middle east customs guide - dhl

MIDDLE EAST CUSTOMS GUIDE V3 July 2012

The Information provided is based on customs regulations and requirements as of 29th July 2012. Please note customs regulations and sanctions are fluid and may change, we will provide updated information in a timely fashion however the information communicated in this document from June 2012 onwards is to be used as a guide.

SAUDI ARABIA

SAUDI ARABIADocumentation Requirements

Saudi Arabia Gateway Details

Import Requirements

Product Labeling & Country of Origin Markings

Commercial invoice

Certificate of Origin

SASO

Authorization Letter

Customer Reference Documents

Kingdom of Saudi Arabia Websites

KUWAITDocumentation Requirements

Commercial invoice


Certificate Of Conformity

Shipment Labeling

BAHRAINDocumentation Requirements

Commercial invoice

OMANDocumentation Requirements

Commercial invoice

QATARDocumentation Requirements

Commercial invoice


Authorization letter

Legalization Charges – Road Shipment

Legalization Charges – Air Shipment

Additional Import Requirements

Product Labeling & Country of Origin Markings

UNITED ARAB EMIRATESDocumentation Requirements

Commercial invoice

YEMENDocumentation Requirements

Commercial invoice


Broker Arrangements

LEBANONDocumentation Requirements

Commercial invoice

Broker Arrangements

JORDANDocumentation Requirements

Commercial invoice

Broker Arrangements

IRAQDocumentation Requirements

Oil & Gas Imports For Southern Iraq

Commercial invoice


AFGHANISTANDocumentation Requirements

Commercial invoice

SYRIADocumentation Requirements

Commercial invoice

EGYPTDocumentation Requirements

Customs Clearance Paperwork

Special approvals for inbound shipments

Commercial invoice


KUWAIT BAHRAIN OMAN QATAR UAE YEMEN LEBANON JORDAN EGYPT IRAQ AFGHANISTAN

WELCOME TO DHL EXPRESS MIDDLE EAST CUSTOMS GUIDE

SYRIA

KINGDOM OF SAUDI ARABIA CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS

CERTIFICATE OF ORIGIN

SAUDI ARABIA GATEWAY DETAILS

SASO

IMPORT REQUIREMENTS

AUTHORIZATION LETTER

PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS

CUSTOMER REFERENCE DOCUMENTS

COMMERCIAL INVOICE

KSA WEBSITES

KINGDOM OF SAUDI ARABIA

Gateways Dhahran Causeway Riyadh Airport

Line Haul DHL B727 DHL road movements

DHL Clearance Yes

Broker Handover Not possible

DDP Yes

Deminimus US$150.00





SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES



The following documents are required to complete the clearance of a shipment into Saudi Arabia

1. Airwaybill

2. Detailed Commercial Invoice

3. Packing List

4. Certificate of Origin The requirement for a COO is value dependent and varies by gateway

5. Saudi Arabian Standards Organization (SASO) Required for certain products

6. Company Registration Importer to provide a copy of a valid Company Registration

7. Authorization Letter Importer to provide Authorization letter to DHL to act as their broker

The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES


KINGDOM OF SAUDI ARABIA GATEWAY DETAILS

Dhahran Causeway1. Shipments consigned to locations in the Eastern Province of Kingdom of Saudi Arabia are cleared at the DHL facility on the Bahrain –

Kingdom Of Saudi Arabia Causeway.

2. The Causeway is also the primary clearance point for road shipments entering Kingdom of Saudi Arabia.

3. Shipments for the Central & Western Provinces with values exceeding US$5,300 are also cleared on the Causeway.

4. “Shipments valued in excess of US$13,149 require a Certificate of Origin if clearing at the Causeway”.

Riyadh1. Shipments consigned to locations in the Central Province of Kingdom of Saudi Arabia are cleared at the DHL facility at the Riyadh Airport.

2. Only shipments with values less than US$5,300 can be cleared.

3. Shipments for the Central Province with values exceeding US$5,300 are cleared on the Causeway.

4. Shipments valued in excess of US$2,500 require a Certificate of Origin “If clearing at Riyadh Airport”.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES


IMPORT REQUIREMENTS

Importer of Record• All shipments with a value above US$100 require that the Company or individual be identified as

the Importer of record (IOR).

• DHL cannot act as the importer of Record into Kingdom of Saudi Arabia

Company Registration• The customs declaration form prepared by DHL at time of customs clearance must be accompanied

by a copy of the consignee’s commercial registration or personal ID.

• Copies of CR’s & ID’s provided by importers will be kept on file by DHL for use as and when required.

Authorization Letter (AL)• For shipments valued at > US$13,249 for DHA or US$2,499 for JED & RUH an original letter

authorizing DHL to act as the clearance broker on behalf of the customer is required.

• The AL should be in the approved format and on the company letter head.

• The AL can be issued for a period of 12 months and will be kept on file by DHL for use as and when required.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES


IMPORT REQUIREMENTS

Saudi Arabian Standards Organization (SASO)• SASO approval is required for some items valued at over US$ 100 . The exporter should check the

SASO website to confirm if the products they are shipping require SASO approval.

• SASO is similar to a Clean Report Finding (CRF) and can be obtained from a reputable inspection company such as Intertek. SGS or Bureau Veritas.

Certificate of Origin (COO)• All shipments for DHA above US$ 13,249 require a COO.

• All shipments for JED & RUH above US$ 2,500.00 require COO.

Communications and Information Technology Commmission (CITC)• All telecommunications related equipment and spare parts are subject to CITC approval.

• The consignee is responsible for obtaining CITC approval and this must be in place before the shipment is collected. A copy of the CITC approval should be attached to the shipping documents




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES



1. Product labeling indicating the Made In and brand name are compulsory for any products to be exported to Saudi Arabia.

2. Labeling is required for all products and is particularly important for spare parts, finished goods, food products, personal care products, health care products, and pharmaceuticals.

3. Where physically possible the actual product should be embossed / engraved or have an irremovable label stating the made in country as well as the product brand name.

4. Where product labeling is not possible due to size or product sensitivity the external packing should carry the required markings.

5. SASO has specific requirements for identifying marks and labels for various imported items. Companies can request a copy of the labeling requirements on the SASO website : www.saso.org.sa/English/Pages/Default.aspx

6. Shipments / parts which do not have a country of origin stamp or sticker may be rejected for clearance by Saudi Customs and returned to origin.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES


COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)

PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS

COMMERCIAL INVOICE

Invoice no 25Date 01/04/2010

Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683

DescriptionCountry of

originNet

weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD

Total price, USD:

Insurance cost, USD:

Freight cost, USD:

Total for payment, USD:

Gross Weight (total):

Signed by:

Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining

viscose(100%)

Italy,Lignano spa 5 kg 61042900 10

7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg

Signature, Stamp of CNOR

Italy,Lignano spa

China, BailihuaTrade ltd

Malaysia, Intertrade ltd

Italy, Masterprint

srl


viscose(100%)

Sweater, mod, Holiday, trade mark Mosiac; wool(98%),

polyester(2%)

Brush for cleaning of clothes, plastic 100%

Catalogues Loops

Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef

Phone: + 971 56 1547700

Delivery terms (Incoterms): CIF

An invoice number is mandatory for the invoice.

Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.

HS Code essential as well as country of origin

Signature and company stamp

Realistic valuation required. Provide unit price as well as total price

Same currency throughout the invoice.

Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,

The name and addresses should match the consignee’s registration documents.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES



Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Saudi Embassy or Consulate in THE ORIGIN COUNTRY – “local”, “in the origin country” , Saudi, in the Origin Country do not have to be in Uppers case, was meant to show you the placement and replacement of words – please change to lower care.

When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.

For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES


SASO

The role of SASO in Kingdom of Saudi Arabia is primarily consumer protection and the maintenance of public health and safety as well as environmental protection and the guarantee of the well being of the general public through the issuing and implementing of standards, quality and metrology systems.

Web Site www.saso.org.sa/English/Pages/Default.aspx

All shipments are subject to mandatory verification prior import clearance into Saudi Arabia and related certificate is required for clearance.

Exceptions are limited to specific products.

Products for which conformity to SASO standards is mandatory shall have been subject to satisfactory laboratory testing.

Conformity to international and equivalent standards is recognized.

Products shall also comply with national deviations such as :

Language (Instructions in Arabic)

Local climate

Electric supply (domestic 127/220V, 60Hz) and electric plug Religious requirements

SASO certification can be obtained through 3rd party entities such as Bureau Veritas and SGS – (www.bivac.com & www.sgs.com)

Exporters should present documents showing the conformity of their products in accordance with the specified Standards to BVQI / SGS who will assess the documents and the product prior to issuing the SASO certificate.




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES



For shipments clearing through the Causeway were the value exceeds US$13,249.00 the importer is required to issue an Authorization Letter (AL).

For shipments clearing through Riyadh Airport were the value exceeds US$ 2,500.00 the importer is required to issue an Authorization Letter (AL).

This letter authorizes DHL to act as their clearing agent.

The AL can be valid for a specific shipment or for a defined period of time up to a maximum of 12 months.

DHL will retain the original AL on file at the clearance gateway and submit a copy with each shipment cleared for the corresponding importer.

DATE:

Authorization

Civil record #................................... Importer Computer # …………….. Authorization #............................. Import -- Export

Director General of customs King Fahad Causeway Custom Manager Dear Sir, I, Residing in P.O. Box: ------ Zip Code: --------- Tel: … -------. Fax: ---------------- Telex: C.R. #: ------------- Date: ----------- Issued by: ---------On: -------------Expire ---------- Member of Chamber of Commerce and industry In AL-KHOBAR. Holding membership Do hereby state that I have authorize customs broker Name Sameer Hameed Al Judaibi License #.1601 Date 20/01/1411 H To finalize all customs procedures, expedite transactions, submit all require documents, attend inspection and examination, pay customs duties, sign Release card and receive the goods. I also state the following: My commercial activity and goods I deal with and Import and export is The imported goods is: Quantity: Origin: This consignment(s) belong to me personally. I shall Be fully responsible for validity of the information. It is confirming with my statement on the Declaration and documents attached to it. I am also responsible for violation committed in connection with this authorization. This authorization is valid for one year from to

Corporation Name: Signature: ……………………………………………. Seal Chamber of commerce stamp

:

:010263697831 ......................: ..................................:

: :

- .

:

: ----5641--: . --- ---11432

:4919624 : .4919736 : ..............:1010011557

: 10/9/1428 -: .

:30/5/1433 .:

.:160120/01/1411

. :

:

/

.................... .

. -

- 131431131433

: . :

..................................................: .....................................................:




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES



Saudi Food & Drug Authority

Communication & Information Technology Commission

Saudi Arabian Standards Organization




SASO

IMPORT REQUIREMENTS




COMMERCIAL INVOICE

KSA WEBSITES


KINGDOM OF SAUDI ARABIA WEBSITES

SASO – Saudi Arabian Standards Organization

http://www.saso.org.sa/English/Pages/Default.aspx

SFDA - Saudi Food & Drug Authority

http://www.sfda.gov.sa/En/Home

MOCI - Ministry of Commerce & Industry

http://mci.gov.sa/english/default.aspx

CITC - Communications & Information Technology Commission

http://www.citc.gov.sa/English/Pages/default.aspx

For SASO – Certification Bodies

If you need to have goods certified prior to export then please check which of these service providers have an agreement with SASO for your country of origin.

Intertek

http://www.intertek.com/government/product-conformity/exports/saudi-arabia/

SGS Group

http://www.sgs.com/import_certification_me.htm?serviceId=10096307&lobId=5550

Bureau Veritas

http://www.bureauveritas.com/wps/wcm/connect/bv_com/group

KUWAIT CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING

KUWAIT

KUWAIT

Gateways Kuwait Airport (Road & Air) Sulabiya (Road only)

Line Haul DHL 727 DHL road movements

DHL Clearance Yes

Broker Handover Yes

DDP Yes

Deminimus US$0.00


KUWAIT


The following documents are required to complete the clearance of a shipment into Kuwait

1. Airwaybill


3. Packing List

4. Certificate of Origin Required for shipments >100 kilos or where the value is in excess of US$2,999.00.

5. Certificate of Conformity Required for certain products (ICCP - International Conformity Certification Program is required for

certain commodities including all electronics items. The Public Authority for Industry (PAI) is the regulatory authority responsible for ICCP)

6. Legalized Invoices Legalization is required when the shipments value is >100 kilos in weight or where the value exceeds

US$1499.00 Legalization can be done on arrival in Kuwait with cnee paying charges Legalization Costs KD 10.00 per invoice , KD 15.00 for a Cert of Origin, KD 4.00 admin charge



KUWAIT



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











KUWAIT


Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Kuwait Embassy or Consulate in the origin country.




KUWAIT

CERTIFICATE OF CONFORMITY


KUWAIT

SHIPMENT LABELING

1. Labeling and marking requirements are compulsory for any products to be exported to Kuwait.

2. Labeling is required for all products and is particularly important for companies marketing food products, personal care products, health care products, and pharmaceuticals.

3. Kuwait Conformity Assurance Scheme (KCAS) has specific requirements for identifying marks and labels for various imported items.

4. All products should carry a stamp or permanent irremovable sticker which states the country or manufacture.

5. Shipments / parts which do not have a country of origin stamp or sticker will be rejected by Kuwait customs for further actions by importer.

6. For further details customers can visit the following link:

https://www.pai.gov.kw/portal/page/portal/pai/KUCAS

BAHRAIN CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE

BAHRAIN

BAHRAIN

Gateways Bahrain Airport (Road and Air)

Line Haul DHL 727 DHL road movements

DHL Clearance Yes

Broker Handover Yes

DDP Yes

Deminimus US$0.00


BAHRAIN


The following documents are required to complete the clearance of a shipment into Bahrain

1. Airwaybill


3. Packing List

4. Certificate of Origin Required for shipments valued in excess of US$1,300 A penalty of BD10.00 (US$30.00) may be paid in the absence of a Certificate of Origin



BAHRAIN



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700










OMAN CUSTOMS GUIDE


OMAN

OMAN

Gateways Seeb Airport (Road and Air)

DHL Clearance Yes

Broker Handover Yes

DDP Yes

Deminimus US$0.00


OMAN


The following documents are required to complete the clearance of a shipment into Oman

1.Airwaybill

2.Detailed Commercial Invoice

3.Packing List



OMAN



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700










QATAR CUSTOMS GUIDE


LEGALIZATION CHARGES – AIR SHIPMENT

COMMERCIAL INVOICE

ADDITIONAL IMPORT REQUIREMENTS



AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT

QATAR

QATAR

Gateways Doha Airport (Air only)

DHL Clearance Yes

Broker Handover No

DDP Yes

Deminimus US$0.00

QCCSW (Qatar Customs Clearance Single Window) has been effectively implemented in Qatar. Currently, this

applies only for sea freight shipments and implementation for air freight and couriers is yet to be announced.

Qatar customs has now migrated into QCCSW. All importers in Qatar must register their business activity online

with Qatar customs by visiting the Qatar customs website www.ecustoms.gov.qa. It is mandatory for all importers

to have the DHL Qatar license details - DHL QATAR LTD” Under the CR no 4642 - entered as a one time process,

which authorizes DHL Qatar to act on behalf of the importer as a customs clearance broker.

Please advise all importers in Qatar to complete the registration as early as possible to ensure shipments are

cleared from customs without delay

KINGDOM OF SAUDI ARABIA / Qatar Land Border (Road)



COMMERCIAL INVOICE





QATAR


The following documents are required to complete the clearance of a shipment into Qatar

1. Airwaybill


3. Legalized Invoices Legalization can be done on arrival in Qatar with charges paid by the cnee

4. Packing List

5. Certificate of Origin Required for shipments moving by air with a weight exceeding 100 kilos (actual or volumetric) COO required for all shipments moving by road.

6. Authorization Letter




COMMERCIAL INVOICE





QATAR



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700












COMMERCIAL INVOICE





QATAR


Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Qatar Embassy or Consulate in the origin country.





COMMERCIAL INVOICE





QATAR


Required for all shipments and provided by the consignee.

Can be valid for a period of time and for a max period of 12 months after which it needs to be renewed.



COMMERCIAL INVOICE





QATAR

LEGALIZATION CHARGES – ROAD SHIPMENT

Road shipments cannot be moved by paying penalty original certificate of origin has to be present

* All prices in QAR

Shipment Value

From To


Attestation of Commercial

InvoiceTotal Payable

0.4% of declared invoice value

0.01

5,000

15,000

50,000

100,000

150,000

250,000

500,000

1,000,000

4,999

14,999

49,999

99,999

149,999

249,999

499,999

999,999

above

150

150

150

150

150

150

150

150

100

200

500

900

1300

1800

2200

3000

250

350

650

1050

1450

1950

2350

3150



COMMERCIAL INVOICE





QATAR


If the value of the shipment more 50,000QAR 1% will be the fine from invoice value

* All prices in QAR

Shipment Value

From To


Attestation of Commercial

InvoiceTotal Payable

0.4% of declared invoice value

0.01

5,000

15,000

50,000

100,000

150,000

250,000

500,000

1,000,000

4,999

14,999

49,999

99,999

149,999

249,999

499,999

999,999

above

150

150

150

150

150

150

150

150

100

200

500

900

1300

1800

2200

3000

250

350

650

1050

1450

1950

2350

3150



COMMERCIAL INVOICE





QATAR


AGENCY PRODUCTS COMMENTS WEBSITE

Ministry of Health Medicine, Cosmetics, Nutrition foods Will be rwquested on arrival www.sch.gov.qa

Ministry of Interior Security devices, Specialist cameras Will be requested on arrival www.moi.gov.qa

Ministry of Interior Fire related items like Alarm and Equipments Will be rwquested on arrival www.moi.gov.qa

Supreme Educational Council Educational books Will be rwquested on arrival www.education.gov.qa

Qatar General Organization for Standards and Metrology Automotive spare parts Will be requested on arrival for air but must

be obtained in advance for road www.moi.gov.qa

ICT (information & CommunicationTechnology)

Computer items, Network equipments,Wireless devices

Will be requested on arrival for air but must be obtained in advance for road shipments www.ictqatar.qa

EPC (Environmental Protection Council) Chemical, Liquids, Lubricants, Radioactive material

Will be requested on arrival for air but must be obtained in advance for road www.moi.gov.qa



COMMERCIAL INVOICE





QATAR


1. Product labeling indicating the Made In and brand name are compulsory for any products to be exported to Qatar

2. Labeling is required for all products and is particularly important for spare parts, finished goods, food products, personal care products, health care products, and pharmaceuticals.

3. Where physically possible the actual product should be embossed / engraved or have an irremovable label stating the made in country as well as the product brand name.

4. Where product labeling is not possible due to size or product sensitivity the external packing should carry the required markings.

5. Shipments / parts which do not have a country of origin stamp or sticker may be rejected for clearance by Qatar customs and be destroyed or returned to origin.

UNITED ARAB EMIRATES CUSTOMS GUIDE


UNITED ARAB EMIRATES


Gateways Dubai Airport (Air only)

Abu Dhabi Airport ( Air & Road)

DHL Clearance Yes

Broker Handover Yes

DDP Yes

Deminimus US$270.00




The following documents are required to complete the clearance of a shipment into United Arab Emirates

1. Airwaybill


3. Packing List

4. Importer must have a valid import code

There are a number of Free Trade Zones in the UAE including Jebel Ali Free Zone and Dubai Airport Free Zone) where duty is not applicable. Imports to a UAE Free Trade Zone must be consigned to a registered company operating within the Free Trade Zone the shipment is to be delivered to. Import documentation requirements are the same for regular import shipments to the UAE.






COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700










YEMEN CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN BROKER ARRANGEMENTS

YEMEN

YEMEN

Gateways S’anna Airport (Air) Border (Road)

Line Haul Commercial Air DHL road movement

DHL Clearance No – Broker

Broker Handover Yes

DDP NO

Deminimus US$


YEMEN


The following documents are required to complete the clearance of a shipment into Yemen

1. Airwaybill


3. Packing List

4. Certificate of Origin

Required for all shipments valued >US$250.00

The COO must be attested by the Yemeni Embassy



YEMEN



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











YEMEN


Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Yemen Embassy or Consulate in the origin country.




YEMEN

BROKER ARRANGEMENTS

1. DHL does not have a broker license in Yemen and must use the services of a 3rd party broker to clear shipments on behalf of the importer.

2. This is standard practice with the courier industry in Yemen where shipment clearance is outsourced

3. The importer has the option to use their own broker or to engage the services of the DHL broker.

4. If the cnee uses their own broker DHL will hand over the clearance documents to the nominated broker and they will be responsible for clearance and delivery of the shipment.

5. If the cnee uses the DHL broker we will be responsible for the clearance and delivery of the shipment.

6. Brokerage charges are as follows:

from 0-100Kg US$60.00

from 101-300Kg US$75.00

from 301-600Kg US$100.00

from 601-1000Kg US$120.00

More than 1000Kg 12 cent per kilo

LEBANON CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS

LEBANON

LEBANON

Gateways Beirut Airport


DHL Clearance No – Broker clearance

Broker Handover Yes

DDP Yes

Deminimus US$0.00


LEBANON


The following documents are required to complete the clearance of a shipment into Lebanon

1.Airwaybill


3.Packing List

DHL does not have a brokerage license to clear shipments and instead use a 3rd party broker to clear shipments into Lebanon

The importer has the option to use the DHL broker or their own broker.

Note – the use of 3rd party brokers is industry practice in Lebanon and all courier companies are operate in the same way



LEBANON



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











LEBANON

BROKER ARRANGEMENTS

1 .DHL does not have a broker license in Lebanon and must use the services of a 3rd party broker to clear shipments on behalf of the importer.

2. This is standard practice with the courier industry in Lebanon where shipment clearance is only possible through licensed brokers.




6. Brokerage charges are based on shipments value and as follows:

JORDAN CUSTOMS GUIDE


JORDAN

JORDAN

Gateways Amman Airport (Air & road)


DHL Clearance No – Broker clearance

Broker Handover Yes

DDP Yes

Deminimus US$0.00


JORDAN


The following documents are required to complete the clearance of a shipment into Jordan

1.Airwaybill


3.Packing List

DHL can clear shipments up to US$100.00

DHL does not have a brokerage license to clear shipments >US$100.00 and instead use a 3rd party broker to clear shipments into Jordan.

The importer has the option to use the DHL broker or their own broker.

Note – the use of 3rd party brokers is industry practice in Jordan and all courier companies are operate in the same way



JORDAN



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











JORDAN

BROKER ARRANGEMENTS

1. DHL does not have a broker license in Jordan and must use the services of a 3rd party broker to clear shipments on behalf of the importer.

2. This is standard practice with the courier industry in Jordan where shipment clearance is only possible through licensed brokers.




6. Brokerage charges are based on shipments value and range from JD 40.00 to JD 60.00.

SYRIA CUSTOMS GUIDE


SYRIA

SYRIA

Gateways Damascus Airport (Air)

Line Haul Commercial Air

DHL Clearance Yes

Broker Handover Yes

DDP No

Deminimus US$0.00


SYRIA


The following documents are required to complete the clearance of a shipment into Syria

1. Airwaybill


3. Packing List


Shipments > 50 kg ex China or manufactured in China should have a COO certified by Syrian Embassy in China



SYRIA



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700










EGYPT CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN

EGYPT

EGYPT

Gateways Cairo Airport

Line Haul Commercial Air

DHL Clearance Yes

Broker Handover Yes

DDP No

Deminimus US$0.00


EGYPT


The following documents are required to complete the clearance of a shipment into Egypt

1. Airwaybill


3. Packing List


Required for shipments valued at >US$1,999.00

COO must be endorsed by the Egyptian Embassy

5. China (Origin only) shipper must issue Certificate of Inspections & Quarantine “CIQ”

6. Importation registration

7. Bank Transfer form ( proof of payment for commercial shipments).

8. Company or Private use forms

Under Egyptian Postal Authority regulations the maximum weight permissible under a single Airwaybill as a courier shipment into Egypt is 100 kilos. Shipments above 100 kilos will be transferred to main cargo for customs clearance incurring clearance delays of up to 5 days



EGYPT

CUSTOMS CLEARANCE PAPERWORK

Paperwork Required for investment Companies

Ministry Of Investment›s approval

Customs dealing Card Copy

Taxes Card Copy

Commercial Registration Card Copy

Authorization Letter Original

Paperwork Required for Petroleum Companies

EGPC declaration for exemption purposes


Non Exemption clearance process will require

Co’s registration Copy

Taxes Card Copy

Paperwork Required for Diplomatic Entities

Ministry Of Foreign Affairs approval required to release shipments without inspection & for duty exemption purposes.



Paperwork Required for Industrial Companies

Industrial License Copy


Taxes Card Copy


Form 6 (For Company use)

Form 5 (For industrial use)

Bank form 4 for industrial use -declare value is + US$ 5,000.00

Paperwork Required for Commercial Companies

Import License Copy


Taxes Card Copy


Internal use form stamped and signed

Bank Form 4 for industrial use where value >US$ 5,000.00


Paperwork Required for Free Zone Companies


Free Zone declaration original form

Paperwork Required for Repair & Return “R&R”


Taxes Card Copy


126 KM original Form

R&R Invoice shows repair cost

Serial number must be engraved on all parts

If shipment arrives with a different serial number, customs will treat shipment as a new unit (subject to duty and taxes)


EGYPT

SPECIAL APPROVALS FOR INBOUND SHIPMENTS

DESCRIPTION OF GOODS REGULATORY AUTHORITIES NAME

Food or food samples Ministry of Health

Seeds / Plants Ministry of Agriculture & Land Reclamation

Video cassettes, CDs, DVDs The Public Authority For Audio & Visual Works Censorship

Color printer, Scanners The Ministry of Interior Public Security Department

Telephones (regular/cellular) and telecom equipment, GPS Ministry Of TelecommunicationNational Telecommunication Regulatory Authority - “NTRA”

Satellite receiver Ministry Of Telecommunication

Books , Brochure, Magazine Ministry Of Culture

Drugs,medical product, Cosmetics: Dental instruments: Ministry of Health Population. Central Administration of Pharmaceutical Affairs

Films Films Import & Export Licenses Committee

Wooden products Ministry of Agriculture & Land Reclamation


EGYPT



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











EGYPT


Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Egypt Embassy or Consulate in the origin country.



IRAQ CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS OIL & GAS IMPORTS FOR SOUTHERN IRAQ COMMERCIAL INVOICE CERTIFICATE OF ORIGIN

IRAQ

IRAQ

Gateways Basra, Baghdad and Erbil Airports

Line Haul DHL & Commercial Air

DHL Clearance Yes

Broker Handover Yes

DDP No

Deminimus US$


IRAQ


The following documents are required to complete the clearance of a shipment into Iraq

1.Airwaybill


3.Packing List

See separate slide on import requirements for the Oil and Gas industry in Southern Iraq.



IRAQ

OIL & GAS IMPORTS FOR SOUTHERN IRAQ

Dutiable Shipments1. Commercial Invoice (English & translated into Arabic)2. Packing list (English & translated into Arabic)3. Certificate of Origin (endorsed by Iraqi Embassy)4. Certificate of Conformity (only were required by the Iraqi authorities)5. Import license from relevant ministry – based on the imported product (example: medicine – need approval from Ministry of Health)

Non Dutiable / South Oil Company (SOC) Contract1. Commercial Invoice (English & translated into Arabic)2. Packing list (English & translated into Arabic)3. Certificate of Origin (endorsed by Iraqi Embassy)4. Copy of the Contract with SOC (translated into Arabic)5. Letter from the consignee declaring whether shipment is temporary or permanent import (also needs to be translated into Arabic)6. Original HAirwaybill copy (provided by DHL)

Important Notes:Exemptions for O&G shipments are only applicable to importers/Consignees that have contracts with the SOC and the imported items are part of the agreed contracted list of items. SOC manage and regulate all O&G imports into the Southern Governate of Iraq and work hand in hand with the customs. SOC determine what paperwork and documentation are required in clearance and they are the only ones authorized to issue permits for exemption material in South Iraq. SOC Brokers are employees of SOC working for the SOC – they are not 3rd party independent brokers thus DHL cannot replace them or performtheir activities.

Any shipment arriving without a COO will be detained in customs and there will be a deposit fee of (Iraqi Dinar) ID 250,000 to ID 750,000 depending on the declared value. Be advised that values are reassessed by customs if deemed to low based on internal Iraqi Custom Guidelines.

If COO is not produced within 30 days – the deposit will be CONFISCATED and official receipt will be provided.


IRAQ



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











IRAQ


Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Iraq Embassy or Consulate in the origin country.



AFGHANISTAN CUSTOMS GUIDE

DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE INCOTERMS 2012

AFGHANISTAN

AFGHANISTAN

Gateways Kabul Airport

Line Haul DHL

DHL Clearance Yes

Broker Handover Yes

DDP No

Deminimus US$0.00


AFGHANISTAN


The following documents are required to complete the clearance of a shipment into Afghanistan

1. Airwaybill


3. Packing List

4. Authorization letter for DHL to act as importers broker.

Approval from Kabul US Embassy is required to proceed with any import exemptions. Approval will be granted after letter of exemption is received from the Military/ISAF.

Exemption process takes an average of 2-3 weeks for standard cargo & 4-5 weeks for any medical shipments, military supplies



AFGHANISTAN



COMMERCIAL INVOICE




originNet


Total price, USD:


Freight cost, USD:



Signed by:


viscose(100%)


7,6 kg 6104290000 15

4 kg 6110111000 34

3,1 kg 3924909000 100

6,3 kg 4911101000 5

500

500

45

5

10

5000

7500

1530

500

50

14580

200

9500

24280

30 Kg


Italy,Lignano spa



Italy, Masterprint

srl


viscose(100%)


polyester(2%)


Catalogues Loops


Phone: + 971 56 1547700











AFGHANISTAN

INCOTERMS 2012

MIDDLE EAST REGION CUSTOMS GUIDE

ADDITIONAL SERVICES GLOSSARY OF TERMS DISCLAIMER

ADDITIONAL SERVICES

Importer of Record DHL cannot act as an importer of recorder but can assist in identifying an entity that can act as an IOR in the destination country.

Repair & Return DHL can support repair and return services in most countries.

Temporary Import Services DHL can support temporary import services in most countries.

Documentation Services DHL can provide documentation services such as Certificate of Origin, SASO, Certificate of Conformity and invoice legalization either directly or through 3rd party service providers.

Break Bulk Services DHL can support Break Bulk services in a number of countries

Duty Exemptions DHL can support the importation of goods that are exempted from duty once the importer has the required exemption approvals.

Ministerial Approvals DHL can assist the importer in obtaining ministerial approvals but is unable to act on behalf of the importer where they are required to make the application directly with the relevant ministry / agency.


GLOSSARY OF TERMS

Deliver Duty Paid (DDP) Duty is paid at destination and billed back to the shipper

Certificate of Origin (COO) Required in certain countries to demonstrate true origin of the shipment.

Authorization Letter (AL) Approval from the importer to permit DHL to act as their broker.

Importer of Record (IOR) Registered importer of goods into country of final destination.


DISCLAIMER

The information included in this guide is designed to provide general guidance on the basic import requirements for countries in the Middle East region. It is not a definitive document and should be used primarily as a basic introduction to customs requirements across the region. Should a customer have more specific questions regarding import regulations and requirements the DHL customs and operational teams will be happy to respond in detail.

Procedures for Obtaining ICT Equipment Approval

The Communications and Information Technology Commission (CITC) is mandated by its Statutes to

license ICT equipment to be used in the Kingdom of Saudi Arabia. Any party desiring to get equipment

approval of any wireline or wireless ICT equipment is required to follow the following procedures.

First Step: Equipment Approval Application Form

1. Complete the Equipment Approval Application Form on the CITC website www.citc.gov.sa for

each piece of equipment of one model.

2. Print out the application form on the official letterhead of the organization or company.

3. Attach the following documents to the application form:

1. Detailed technical information and catalogues of the equipment, including description of

the mechanism by which the equipment and its accessories will be operated, the planned

applications, and data related to the public network interface characteristics and

compatibility.

2. Declaration of Conformity from a test lab accredited by the International Laboratory

Accreditation Cooperation (ILAC) that the equipment conforms to the international

standards approved by CITC.

3. Certification from the manufacturer including an undertaking that the equipment

conforms to the CITC technical specifications. The certification must be signed by an

authorized officer of the manufacturer.

4. A report certified by the test labs providing details of the approved tests that were

performed for the equipment and the results of those tests.

5. A statement identifying the names and addresses of the test labs and the dates the tests

were conducted. If the tests were conducted by independent test labs, names of the

countries that have accredited the test labs for the equipment should also be indicated.

6. If the equipment supports encryption systems, provide the details of the equipment types

from the manufacturer.

7. CITC may require the equipment supplier to provide a sample for testing.

http://www.citc.gov.sa/

Second Step: Application Submission

After completing the application with all required documents, it should be hand delivered or

mailed to the following address:

Technical Standards and Type Approval Department, Technical Affairs Sector,

Communications and Information Technology Commission, King Fahad Road, Rahmaniya

District, PO Box 75606, Riyadh 11588, Kingdom of Saudi Arabia; Tel +966‐14618000. It may

also be hand delivered to one of the CITC branches. Acknowledgement of receipt of the

documents should be obtained from the receiver at CITC if hand delivered.

Third Step: Application Follow‐up

CITC will send the result of the tests to the applicant either by regular mail, fax or email.

Equipment Approval Request Form جهازنموذج طلب اعتماد :Date: Request No :التاريخ :رقم الطلب

Information on the enterprise submitting the قدمة الطلب مالجهةمعلومات application

:Name of the enterprise :الجهةاسم

الرمز /ب .ص( :)البريدي

Postal Code:

:Tel :الهاتف

:Fax :الفاآس

:E-mail :البريد اإللكتروني

:Contact Person :المسئول اإلداري

:Mobile Phone :الهاتف المتنقل

لها شهادة المطابقةالصادرة معلومات الجهةInformation on the enterprise to which conformity Certificate will be issued:

:Name of the enterprise :اسم الجهة

Device Details بيانات الجهاز

:Product Name :اسم المنتج

:Product model :موديل المنتج

:Manufacturer :الشرآة المصنعة

:Product Description :وصف عمل المنتج

رقم مواصفة الهيئة :المطابقة للجهاز

CITC Technical Specification Number:

Additional Details بيانات إضافية

:Operating Frequency :الترددات المستخدمة

قدرة الخرج القصوى )ERIP:(

Maximum Transmit Power (ERIP):

Antenna Gain :آسب الهوائي

اقر أنا الموقع أدناه بأن آافة البيانات المذآورة أعاله :صحيحة

I, the undersigned that all the above statements are true:

Applicant's Name اسم مقدم الطلب

Applicant's Signature توقيع مقدم الطلب

ختمال لالستعمال الرسمي

For official use

Stamp

Sort by: None

Number Type Category Approval Name

AI001 Analog Interface PSTN Equipment connecting to the Analogue PSTN

AI003 Analog Interface DSL Equipment connecting to ADSL, ADSL2 and ADSL2+ Services

DI001 Digital Interface Digital Interface Equipment connecting to 2.048 Mb/s Digital Leased Line Services

DI002 Digital Interface Digital Interface Equipment connecting to 34 Mb/s Digital Leased Line Services

DI003 Digital Interface Digital Interface Equipment connecting to Co-directional G.703 Digital Leased Line Services

DI004 Digital Interface Digital Interface Equipment connecting to X.25 Packet Switched Networks

DI005 Digital Interface Digital Interface Equipment connecting to High Speed Serial Interfaces (HSSI)

DI006 Digital Interface Digital Interface Equipment connecting to 64Kbit/s Services

DI007 Digital Interface Digital Interface Equipment connecting to X.21 Services

DSL001 Digital Subscriber Line

Digital Interface Equipment connecting to SHDSL Services

GEN001 General General

Glossary General

IT001 Information Technology

General IT Equipment


Voice over IP Voice over IP Equipment ( Private usage only )


Radio Links Laser P-P-Links Equipment


Fibre Optics Fibre Optics Equipment


Receivers Receivers with Internet Support

RI001 Radio Interface GSM GSM Handsets, Terminals and Ancillary Equipment

RI002 Radio Interface GSM GSM Base Station and Ancillary Equipment

RI003 Radio Interface Paging Paging terminals and Ancillary Equipment

RI004 Radio Interface Paging Paging Base Stations and Ancillary Equipment

RI009 Radio Interface PMR Analogue PMR handsets and Ancillary Equipment

RI010 Radio Interface PMR Analogue PMR base stations Ancillary Equipment

RI011 Radio Interface TETRA TETRA handsets and Ancillary Equipment

RI012 Radio Interface TETRA TETRA base stations and Ancillary Equipment

RI013 Radio Interface TETRAPOL TETRAPOL handsets and Ancillary Equipment

RI014 Radio Interface TETRAPOL TETRAPOL base stations and Ancillary Equipment

RI015 Radio Interface APCO APCO 25 handsets and Ancillary Equipment

RI016 Radio Interface APCO APCO 25 base stations and Ancillary Equipment

RI017 Radio Interface iDEN iDEN handsets and Ancillary Equipment

RI018 Radio Interface iDEN iDEN base stations and Ancillary Equipment

RI019 Radio Interface Citizens’ Band Citizens’ Band radio and Ancillary Equipment

RI021 Radio Interface Amateur Radio Amateur Radio and Ancillary Equipment

RI022 Radio Interface Mobile satellite Mobile satellite service (MSS) <1GHz Terminals and Ancillary Equipment

RI023 Radio Interface Mobile satellite Mobile satellite service (MSS) > 1GHz Terminals and Ancillary Equipment

RI025 Radio Interface Mobile satellite SPCN Mobile Satellite Service (MSS) Terminals and Ancillary Equipment

RI026 Radio Interface V-SAT V-SAT Terminals and Ancillary Equipment

RI027 Radio Interface other Satellite News Gathering (SNG) Transportable Earth Stations and Ancillary Equipment

RI028 Radio Interface other SIT and SUT Terminals and Ancillary Equipment

RI029 Radio Interface Radio MF Radio MF (AM) Broadcast Services Equipment and Ancillary Equipment

RI030 Radio Interface Radio MF Radio MF (FM) Broadcast Services Equipment and Ancillary Equipment

http://www.citc.gov.sa/English/RulesandSystems/RegulatoryDocuments/EquipmentApproval/Equipment%20Approval/TA%20900%20E%20AI001.pdf

http://www.citc.gov.sa/English/RulesandSystems/RegulatoryDocuments/EquipmentApproval/Equipment%20Approval/TA%20901%20E%20AI003.pdf

http://www.citc.gov.sa/English/RulesandSystems/RegulatoryDocuments/EquipmentApproval/Equipment%20Approval/TA%20904%20E%20DI001.pdf








http://www.citc.gov.sa/English/RulesandSystems/RegulatoryDocuments/EquipmentApproval/Equipment%20Approval/TA%20910%20E%20DSL001.pdf

http://www.citc.gov.sa/English/RulesandSystems/RegulatoryDocuments/EquipmentApproval/Equipment%20Approval/TA%20913%20E%20IT001.pdf





http://www.citc.gov.sa/English/RulesandSystems/RegulatoryDocuments/EquipmentApproval/Equipment%20Approval/TA%20918%20E%20RI001.pdf

























RI031 Radio Interface Radio Links Point to Point (PP) Radio Fixed Links

RI032 Radio Interface Radio Links Multipoint (PMP) Radio Fixed Links

RI033 Radio Interface other Wireless Local Loop Subscriber Equipment

RI034 Radio Interface other Wireless Local Loop Base Stations and Ancillary Equipment

RI035 Radio Interface other Broadband Wireless Access Subscriber equipment, Base Stations and Ancillary Equipment

RI037 Radio Interface other Wireless Telemetry Equipment

RI038 Radio Interface other Analogue Cordless Telephones, Base Stations and Ancillary Equipment

RI040 Radio Interface DECT DECT Cordless Telephones Handsets and Ancillary Equipment

RI041 Radio Interface DECT DECT Base Stations and Ancillary Equipment

RI044 Radio Interface SRD Radio Microphones/In-Ear Monitoring and Ancillary Equipment

RI045 Radio Interface other Wideband Data Transmission systems and Ancillary Equipment

RI048 Radio Interface Detection of Movement

Detection of Movement Equipment, Tanks Level Probing Radar Applications and Ancillary Equipment (Radio determination Applications)

RI049 Radio Interface other Road Transport, Traffic Telematics and Ancillary Equipment

RI050 Radio Interface SRD Inductive Applications and Ancillary Equipment

RI051 Radio Interface other Ground and Airborne Model Control Equipment

RI052 Radio Interface SRD Radio Hearing Aids

RI053 Radio Interface other Wireless Audio Applications Equipment

RI054 Radio Interface SRD Non-Specific Short Range Devices and Ancillary Equipment

RI055 Radio Interface SRD Radio Frequency Identification (RFID) Equipment

RI056 Radio Interface UMTS UMTS (3G) handsets and related Equipment

RI057 Radio Interface UMTS UMTS (3G) Handsets Base Stations and Related Equipment

RI058 Radio Interface WiMAX WiMAX Subscriber equipment, Base Stations and Ancillary Equipment

RI080 Radio Interface other Tracking, Tracing and Data Acquisition Equipment

RI081 Radio Interface other Avalanche Beacons

RI082 Radio Interface SRD Alarms

RI083 Radio Interface SRD Medical devices

RI084 Radio Interface other Animal implantable devices

RI085 Radio Interface SRD Ultra Wideband Equipment

RI086 Radio Interface Broadcasting Broadcasting DAB Transmitting Equipment

RI087 Radio Interface Broadcasting Broadcasting DVB Transmitting Equipment

RI088 Radio Interface other Digital Radio Mondiale (DRM) Equipment

RI089 Radio Interface Powerline Powerline Equipment

RI090 Radio Interface Navigation Navigation (Air) Equipment

RI091 Radio Interface Navigation Navigation (Ground) Equipment

RI092 Radio Interface Navigation Navigation (Water) Equipment

RI093 Radio Interface GSM Alarm Systems with GSM

RI094 Radio Interface other Wireless beamer

RI095 Radio Interface SRD Cameras with radio Interfaces

RI096 Radio Interface other Emergency Beacons

RI101 Radio Interface SRD Wireless HD Equipment

RI102 Radio Interface other GPS Receiver

RI103 Radio Interface SRD Bluetooth Equipment

RI104 Radio Interface SRD Zigbee Equipment

RI105 Radio Interface WiFi WiFi Router with WiMAX

RI106 Radio Interface WiFi WiFi Router with UMTS (3G)

RI108 Radio Interface other Software Defined Radio Equipment (SDR)

RI109 Radio Interface Receivers DAB, DVB and DRM Broadcasting Receivers

RI110 Radio Interface GSM Encryption GSM Equipment

R I111 Radio Interface other Automatic Identification System (AIS) Equipment




















































بموجب الصالحيات الممنوحة لها وفقا ألنظمتها ) الهيئة(تعتبر هيئة االتصاالت وتقنية المعلومات

هي الجهة المسئولة عن إصدار التراخيص الالزمة الستخدام أجهزة االتصاالت وتقنية المعلومات ية ألجهزة االتصاالت وتقنفسح جمرآي أية جهة ترغب في الحصول على ويتعين علىبالمملكة،

:إتباع اإلجراءات التاليةالمعلومات

لغير مشغلي - أجهزة محجوزة بالجمرك وترخيص فسحنموذج نموذج طلب : أوال شبكات االتصاالت العامة

لغير مشغلي شبكات االتصاالت - أجهزة محجوزة بالجمرك وترخيصفسحطلب " تعبئة نموذج .1

:آالتالي sa.gov.citc.www موقع الهيئة االلكترونيالمنشور على "العامة :الشحنةبيانات - أ

البيانات الخاصة بالجهة الموردة للشحنة باإلضافة إلى البيانات المعرفة للشحنة مع إيضاح هي . إليه الشحنة من حيث االستخداملمن تعود

:الشحنةمحتويات - بدها، وعند امتالء الخانات بجدول بمحتويات الشحنة فإنه يانات األجهزة المراد استيراتفاصيل ب

.يتطلب إضافة صفوف جديدة للجدول :الغرض من استيراد األجهزة المضمنة بالشحنة - ت

.إيضاح سبب استيراد هذه الشحنة .اإلقرار - ث

. صحة المعلومات المدونة بالنموذجتحمل مسئولية . الشرآةطباعة الطلب على الورق الرسمي الخاص بالمؤسسة أو .2 :إرفاق الوثائق التالية .3

.)Airway bill (صورة من بوليصة الشحن - أ .)Packing list(صورة من بيان التعبئة - ب .)Invoices (الفواتيرمن صورة - تاألجهزة والكتالوجات الخاصة بتلك)Technical Specification(البيانات الفنية التفصيلية - ث

المتعلقة اتالتطبيقات المزمعة لها والبيانوصف آللية عمل األجهزة وملحقاتها و شاملة .لالتصاالت العامة مع الشبكاتةموالموائ بخصائص الربط

تتضمن التعهد بأن األجهزة (Declaration of Conformity)شهادة من الجهة المصنعة - جالمعنية تطابق المواصفات الصادرة عن هيئة االتصاالت و تقنية المعلومات، على أن يتم توقيع

.وآذلك المورد لشهادة من قبل صاحب الصالحية لدى الجهة المصنعةامن الشرآة المصنعة ما يوضح األجهزة تدعم أنظمة تشفير فإنه يلزم موافاتنا آانتفي حال - ح

.نوع هذه األنظمة :آما يجب توفير الوثائق التالية في حال تم طلبها من قبل الهيئة - خ

ص التي تم فيها إجراء الفحوصات على األجهزة بيان يوضح أسماء وعناوين مختبرات الفح .1المعنية مع إيضاح تاريخ إجراء الفحوصات، وذلك في الحاالت التي تكون األجهزة قد تم


فحصها في مختبرات مستقلة مع إيضاح أسماء الدول التي اعتمدت المختبرات التي قامت .بإجراء الفحوصات

تقرير معتمد يوضح تفاصيل الفحوصات التي تم إجراؤها على األجهزة ونتائج تلك .2وعلى المورد االحتفاظ لديه بنتائج الفحوصات وإبرازها لدى طلبها من قبل . الفحوصات

.الهيئة

تعهدات:ثانيا

طلب وفي حال .sa.gov.citc.www موقع الهيئة االلكترونيالمنشورة على قائمة التعهداتيرجع إلى ) الشرآة/المؤسسة(توقيع أي تعهد من التعهدات فإنه يلزم طباعتها على األوراق الرسمية الخاصة بـ .مع إرفاق صورة من السجل التجاري و صورة من بطاقة أحوال الموقع على التعهد

استيراد أجهزة لطرف آخر :ثالثا

عائد إلحدى الجهات الحكومية او غير الحكومية مشروعسيجري توريدها ضمن إذا آانت األجهزة

وطبيعة يوضح ملكيتها لهذه األجهزةفيجب على المورد إرفاق خطاب من الجهة المستفيدة . األجهزةاتاستخدامها ويدون بالخطاب رقم بوليصة الشحنة وموديالت وآمي

أخرىرخص: رابعا

مثل ( من الهيئة مسبقةاستيرادها يتطلب استخدامها الحصول على رخصةإذا آانت األجهزة المراد

، فيجب )رخصة تقديم خدمة أو رخصة استخدام طيف ترددي أو رخصة جهاز اتصاالت السلكي .ترخيص ساري المفعولذلك الإرفاق صورة من

الكشف الفني: خامسا

راء الفحوصات عليهاقد تطلب الهيئة من مورد األجهزة تزويدها بعينه منها ألج. ينبغي على الجهة الموردة األمر الكشف على الشحنة المحجوزة بالجمرك فإنه تطلبفي حال

.القيام بحجز األجهزة في قسم المحجوزات بالجمرك، تمهيدا للكشف الفني تتطلب في حال أن الشحنة المحجوزة المراد الكشف عليها تحتوي على أجهزة اتصاالت السلكية

. العائد لها الشحنة الترددات المخصصة للجهةفإنه يلزم ضبط تردداتها على ترددات، تخصيص يجوز للهيئة أخذ عينات من الشحنة المراد الكشف عليها.


تقديم الطلب: سادسا

:يرسل هذا الطلب إلى العنوان التالي/ بعد إآمال الطلب مع جميع الوثائق المطلوبة يسلم – هيئة االتصاالت وتقنية المعلومات - قطاع الشئون الفنية -ية واعتماد النوعية إدارة المعايير الفن , المملكة العربية السعودية11588 الرياض 75606ب . ص- حي الرحمانية -طريق الملك فهد

.أو احد فروعها واستالم رقم للمعاملة , )+966-1-4618000هاتف (

متابعة الطلب :سابعا ب عن طريق الحضور للمرآز الرئيسي للهيئة أو أحد فروعها أو االتصال على يمكن متابعة الطل

+).966-1-4618000(الهاتف رقم يتم إرسال إذن الفسح إلى المنفذ الجمرآي مباشرة، وتزود الجهة الموردة بصورة من إذن الفسح

.للمتابعة، وذلك عن طريق البريد السريع دة بذلكفي حال التعذر يتم إبالغ الجهة المور .

لغير مشغلي شبكات االتصاالت العامة- أجهزة محجوزة بالجمرك وترخيص فسحنموذج طلب

:التاريخ :الرقم سعادة نائب المحافظ للشؤون الفنية

السالم عليكم ورحمة اهللا وبرآاته .طلب وفقا لألنظمة المعمول بها في الهيئةهذا الاسة لذا آمل من سعادتكم در, أفيدآم بأننا استوردنا األجهزة حسب البيانات المدونة باألسفل

,,,نا تحياتتقبلواو

الشحنةبيانات اسم الجهة مقدمة الطلب

الهاتف العنوان عنوان الجهة مقدمة الطلب

الرمز البريدي المدينة ب.ص الفاآس

إيصال الحجز/ رقم البوليصة

رقم الفاتورة

الشحنة به ة المحجوزالمنفذ الجمرآي

الجهة العائدة إليها الشحنة

الشحنةمحتويات ذه األعمدة في حال آون األجهزة السلكيةتعبأ ه

اسم المنتج Product Name

نوع الجهازDevice Type

الموديلModel

الشرآة المصنعةManufacturer

الكميةQuantity

الترددات التي يعمل عليها الجهاز

Operating Frequencies

قدرة الخرجOutput Power

آسب الهوائيAntenna Gain

1

2

3

4

5

6

: ةالغرض من استيراد األجهزة المضمنة بالشحن

الختم

:اقر أنا الموقع أدناه بأن آافة البيانات المذآورة أعاله صحيحة

اسم المسئول اإلداري

)جوال(رقم االتصال

التوقيع

لالستعمال الرسمي

)رق الرسمي لهافي حال آون مقدم الطلب شرآة أو مؤسسة يتم طباعة النموذج على الو: (يرسل هذا الطلب إلى العنوان التالي/ يسلم -1 (4618000هاتف , المملكة العربية السعودية11588 الرياض 75606ب . ص- حي الرحمانية- طريق الملك فهد- هيئة االتصاالت وتقنية المعلومات - قطاع الشئون الفنية -إدارة المعايير الفنية واعتماد النوعية

966(

Item that require SASO (Pre export CRF)

GROUP I - Toys

No. Item HS Code

I-01

Toys and Playground Equipment 9501/9502/9503/9505/From 9506.99/9508/From 3407/8712.00

GROUP II - Electronics and Electrical Products

No. Item HS Code

II-01 Air conditioning systems up to 60,000 BTU (5 tons)

8415.10.20 / 8415.81.20 / 8415.82.20/ 8415.83.20

II-02 Combined function audio and/or video systems(non-professional)

8518.30 / 8518.50 / 8520.30/ Combinations of II-03, II-04, II-41, II-43

II-03 Non-professional stand-alone audio products(except radio receivers)

8518.21 / 8518.22 / 8518.29 / 8518.40 / 8519.21 / 8519.29 / 8519.31 / 8519.39 / 8519.92 / 8519.93 / 8519.99 / 8520.20 / 8520.90

II-04 Video playing and recording systems(non-professional)

8521.10 / 8521.90 / 8525.40

II-05 Generator sets up to12 KW 8502.11 / 8502.20

II-06 Motors up to12 KW 8501.10 / 8501.31 / 8501.32

/ 8501.40 / 8501.51 / 8501.52

II-07 Fax and telex machines 8517.21 / 8517.22

II-08 Household cooking appliances 8516.60 / 8516.72

II-09 Clothes washing machines up to 10 KG

8450.11 / 8450.12 / 8450.19

II-10 Clothes drying machines up to 10 KG

8451.21

II-11 Electric irons, ironers and clothes steamers and hand-held hair dryers

8516.31 / 8516.32 / 8516.40

II-12 Food processors (non-industrial) 8509.40 / 8509.80

II-13 Meat choppers and grinders (non-industrial) 8509.40

II-14 Lift and elevator systems 8428.10 / 8431.31

Page 1 of 5


II-15 Household microwave ovens 8516.50

II-16 Electric ovens up to 10 KW 8516.60

II-17 Copy machines 9009.11 / 9009.12 / 9009.30 / 9009.21 / 9009.22

II-18 Computers (desktops and portables) and monitors

8471.41 / 8471.49 / 8471.50 / 8471.60 / 8471.70 / 8471.80 / 8473.30

II-19 Power transformers and distribution transformers up to 1,000 KVA

8504.21 / 8504.22 / 8504.31 / 8504.32 / 8504.33 / 8504.34

II-20 Household refrigerators and freezers up to 40 cubic feet

8418.10 / 8418.21 / 8418.22 /8418.29 / 8418.30 / 8418.40

II-21 Telephone sets and modems 8517.19 / 8517.50

II-22 Electric wires and cables up to 1,000V

8544.51 / 8544.59

II-23 Non-industrial vacuum cleaners, water suction appliances and shampooers

8509.10 / 8509.80

II-24 Household electric fires and heaters

8516.21/8516.29

II-25 Drinking water coolers and fountains

8418.69.10

II-26 Evaporative air coolers (desert coolers) up to 1.5 KW

8415.10.10 / 8415.82.10 / 8415.82.90 / 8415.83.10 / 8415.83.90

II-27 Domestic electric fans 8414.51 / 8414.60

II-28 Compressors for cooling units up to 60,000 BTU

8414.30

II-29 Tea and coffee brewing appliances and appliancesfor heating liquids

8516.10 / 8516.71

II-30 Incandescent, fluorescent and discharge luminaires, fixtures, and lampholders

8536.61/ 9405.10 / 9405.20

II-31 Manually operated switches, circuit breakers and fuses up to 30A

8536.10 / 8536.20 / 8536.50

II-32 Incandescent, tubular fluorescent and discharge lamps

8539.21 / 8539.22 / 8539.29 / 8539.31 / 8539.32

II-33 Ballasts for discharge type lamps 8504.10

Page 2 of 5


(including tubular fluorescent lamps)

II-34 Starters for discharge type lamps (including tubular fluorescent lamps)

8532.29 / 8536.50

II-35 General use mains plugs, socket outlets and mains configuration adapters

8536.69

II-36 Luminaires for road and street lighting

9405.40

II-37 Batteries 8506.10 / 8506.30 / 8506.40 / 8506.50/ 8506.60 / 8506.80 / 8507.10 / 8507.30 / 8507.40

II-38 Immersed swimming pool luminaires

9405.40

II-39 Battery terminals and jump cables 8536.90 / 8544.41

II-40 Water pumps up to 12 KW 8413.70

II-41 T.V. sets (color and black/white) 8528.12 / 8528.13

II-42 General use mains voltage converters and power supplies

8504.40

II-43 Stand alone radio receivers 8527.12 / 8527.13 / 8527.19 / 8527.21 / 8527.29

II-44 Storage type water heaters up to 200 liters

8516.10

II-45 Watt hour meters 9028.30

II-46 Cordless telephone sets 8517.11 / 8525.20

II-47 Domestic pressure cookers, including non-electric

7323.93 / 7323.99 / 7615.10

Page 3 of 5


GROUP III - Automotive Products

No. Item H.S. Code

III-01a Passenger automobiles, trucks buses and multi-purpose vehicles (new)

8701 / 8702 / 8703 / 8704 / 8705

III-01b Passenger automobiles, trucks, buses and multi-purpose vehicles (used)

8701 / 8702 / 8703 / 8704 / 8705

III-02 Automotive glass (windshield, side, and rear glass)

7007.21

III-03 Automotive brake fluid 2710.00.94 / 3819

III-04 New tires for passenger automobiles, trucks, buses and multi-purpose vehicles

4011.10 / 4011.20 / 4012.10

GROUP IV - Chemical Products

No. Item H.S. Code

IV-01 Engine, transmission, hydraulic, turbine, and transformer oils

2710.00.52 / 2710.00.53 / 2710.00.54 / 2710.00.55 / 2710.00.95 / 2710.00.96

IV-02 Paints All 3208 / All 3209

IV-03 Perfumes and cosmetics 3302.90 / All 3303 / All 3304 / All 3305 / All 3306 / 3307.10 / 3307.20 / 3307.30 / 3307.49.10 / 3307.90.10 / 3401.11

IV-04 Domestic use pesticides and insecticides

3808

Page 4 of 5


Page 5 of 5

GROUP V - Others

No. Item H.S. Code

V-01 Aluminum and aluminum alloy products for architectural application

7604 / 7606 / 7608 / 7609 / 7610 / 7616

V-02 Steel and iron alloy pipes 7304 / 7305 / 7306 / 7307

V-03 Gold and silver jewelry (including gemstones)

7113.11 / 7113.19 7113.20 / 7114.11 / 7114.19 / 7114.20

V-04 Head dress for men -- cotton shimaghs 6505.91.0

V-05 Fire extinguishers up to 24 KG 8424.10

V-06 Cement 2523.21 / 2523.29.10 / 2523.29.20

V-07 Safety matches 3605.00

V-08 Low pressure regulators for domestic gas cylinders

8481.80.30

V-09 Facial tissue paper 4803 / 4818.20

V-10 Cigarettes only 2402.20

Version 2

GGGuuuiiidddaaannnccceee fffooorrr SSSuuubbbmmmiiissssssiiiooonnn

July 2009

July 2009

Saudi Food & Drug Authority 2009 2

GGGuuuiiidddaaannnccceee fffooorrr SSSuuubbbmmmiiissssssiiiooonnn Version 2

Drug Sector

Saudi Food & Drug Authority

Kingdome of Saudi Arabia

Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug for the latest update

July 2009


Drug Sector

Vision & Mission

Vision

To be the leading regional Drug Regulatory Authority for pharmaceuticals and safety of cosmetic products, with professional excellence and services that contribute to the protection and advancement of public health in the Kingdom of Saudi Arabia.

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،א א א א אא אא אאאאK

Mission

Protecting public health by ensuring safety, quality, efficacy and accessibility of human, veterinary drugs and biological products, and safety of cosmetics, through administration of a national regulatory system which is consistent with international best practice. Through our mission, we also provide accurate and scientific‐based information to the public and healthcare professionals.

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July 2009


Document Control

Version Date Author(s) Comments 1.0 11/05/2009 Licensing department Initial draft for internal consultation

1.1 20/05/2009 Licensing department Draft revision 1.2 06/06/2009 Licensing department Draft revision 1.3 28/06/2009 Licensing department Revisions after management

discussion 2.0 08/07/2009 Licensing department Published for comments

July 2009


Table of Contents

Document Control ............................................................................................................ 4

Table of Contents ............................................................................................................... 5

1 Introduction ................................................................................................................ 7

2 Scope ............................................................................................................................ 8

3 Registration Process ................................................................................................ 9

4 Structure and Content of Submission .....................................................................13

5 Presentation of the Product File ..............................................................................16

5.1 Hardcopy and Softcopy Requirements: ................................................................... 16

5.3 MEDIA ....................................................................................................................... 18

5.3.1 System compatibility: ........................................................................................ 18

5.4 Security ..................................................................................................................... 19

5.4.1 Password protection: ......................................................................................... 19

5.4.2 Virus protection: ................................................................................................ 19

6 Document Requirements .......................................................................................20

6.1 Legibility and Size ..................................................................................................... 20

6.2 Pagination................................................................................................................. 20

6.3 Language .................................................................................................................. 20

6.4 Authentication .......................................................................................................... 20

Appendices .......................................................................................................................21

Appendix A: Data Requirements ................................................................................. 21

Appendix B: Electronic Version of the Paper‐Based Submission ............................. 29

Appendix C: File Formats ............................................................................................. 30

Appendix D: ICH Common Technical Document ........................................................ 34

Appendix E: Target Performance Timelines .............................................................. 37

Appendix F: Required Quantities of Samples ................................................................. 38

Appendix G: References ............................................................................................... 39

Appendix H: Contact Address ...................................................................................... 40

Appendix I: Price List ................................................................................................... 41

Appendix J: Cover Letter .............................................................................................. 42

Appendix K: Laboratory Samples Form ...................................................................... 43

Appendix L: Abbreviation and Acronyms ................................................................... 44

July 2009


July 2009


1 Introduction

The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed

this document, "Guidance for Submission" to assist applicants and industry in the

preparation and submission of drug applications for new Marketing Authorization

(MA) as well as renewals and variations to existing products to the SFDA. The

guidance provides an outline of the way the Framework will be managed with

respect to drug applications by the SFDA.

It is intended to provide clarification to applicants of the way in which the Drug

Sector in the SFDA manage information and material submitted in accordance with

the Regulatory framework for Drug Approvals (version 4). Also, it provides

assistance to comply with the requirements of filing and maintenance of their

application.

Industry representatives, as well as the staff of the SFDA responsible for the

drug application management, will follow this guidance and operational directions

in various areas, including the handling of application information, procedure

related to drug assessment, clarification and performance target of drug

assessments.

To maintain its consistency and enhanced transparency, this guidance will be

updated regularly to reflect the current practices in regulatory sciences. It is

expected that this guidance and any amendments to it will create efficiency in the

drug application management and reduce the number of clarification requests.

It should be noted that the SFDA has the right to request any information and

data within the context of this guidance in order to assess adequately the safety,

efficacy and quality of any medicinal products available in the Kingdom of Saudi

Arabia. The SFDA is committed to ensuring that such requests are justifiable and

decisions are clearly documented.

July 2009


2 Scope

This guidance document applies to all drug submission types:

• Generics

• New drugs (NCE and Known Active Substances)

• Biologics

• Radiopharmaceuticals

• Herbal & Health products

• Veterinary products

• Renewal of MA

• Variations type I & II

All submitted information and material will be screened to ensure that it is

complete and of suitable quality to be reviewed. The same management principles

will be applied consistently to all submission types.

This guidance document covers the preparation and filling requirements for

submissions in paper-based CTD and electronic format. It is based on the ICH

CTD and the eCTD Specifications, and the SFDA Regulatory Framework for Drug

Approval.

This guidance document DOES NOT currently apply to Clinical Trials

Application.

July 2009


3 Registration Process

All Applications will be subjected to the following procedures:

1. Online Filing of Application

The applicant shall fill up the appropriate application form in the SFDA

website. Once completed, application form cannot be submitted unless the

payment details are entered into the system. A reference number will be

assigned to the application once submitted to facilitate the communication with

the SFDA. Then, the applicant will be given an opportunity to book an

appointment to hand over the drug application (figure 1). The earliest

appointment is 1 week, up to 12 weeks in advance. An automatic reminder will

be sent 3 days before the appointment. The applicant can reschedule a week

before the chosen appointment. If it is missed, the earliest appointment that can

be booked is one month after the missed one.

Figure 1: A “Drug Application” includes the application form, the product file and the drug

samples.

2. Acceptance of Drug Application

Upon receipt of the drug application in the appointment day, a checklist for

‘Phase I Validation’ will be used to verify that the information and materials

provided are complete.

July 2009


a. Drug application Without Deficiencies:

The applicant will be notified of the acceptability by printing an

Acknowledgement Letter. Then, the drug application will be forwarded

to the product manager (Licensing Department) for further processing

and assessment. Once these applications are accepted, they will be

assessed in the order in which they are received.

b. Drug application With Deficiencies:

If deficiencies are identified, an Acknowledgment Letter stating the

deficiencies will be issued. The applicant will be required to submit the

requested information within 60 days from the date of the letter. The

applicant will be given only ONE opportunity to complete the file.

• If the applicant has provided the requested information within

60 days, the application will be accepted and the applicant will

be notified of the acceptability by e-mail. The drug application

will be forwarded to the product manager for further processing

and assessment.


60 days but it was found to be still incomplete, the application

will be rejected and the applicant will be required to file a new

application. An acknowledgment letter will be provided to the

applicant.

• If the applicant fails to provide the requested information within

60 days, the drug application will be rejected and securely

disposed of.

3. Phase II Validation

After accepting the drug application from the applicant, the submitted

information and material will be validated to ensure that it has suitable quality

to be assessed. However, if deficiencies are identified, the applicant will be

asked to submit the required information, and it will follow one of the

following cases:

July 2009



60 days, the product file will be forwarded for further

processing and assessment. The applicant will be notified by e-

mail.


60 days but it was found to be still incomplete, SFDA will study

the case and may extend the period for another maximum 30

days. The applicant will be notified by e-mail.

• If the applicant fails to provide the requested information within

60 days, the drug application will be rejected and securely

disposed of.

4. Assessment of Application

All applications will be assessed in terms of quality, safety and efficacy –

as needed – depending on the type of the product.

If issues are identified during the assessment, these issues will be resolved

through electronic Inquiry Forms. Although there is no limitation of inquiries,

it is expected that these issues be resolved by two to three inquiries. Responses

to inquiries are required within 30 days.

5. Pricing

The pricing will be calculated according to the pricing rules outlined in the

pricing guideline.

6. Testing

All drug products will be subjected to appropriate testing according to the

type of the application and dosage form, to ensure the quality of the products as

required by Drug Law. Moreover, the applicant is requested to deliver the

samples to SFDA headquarters as part of the drug application. There will be no

direct contact between the applicant and SFDAs laboratory.

July 2009


7. Inspection

The head of the inspection unit will communicate with the applicant to

decide the appropriate time for inspection – if needed, depending on the

schedules of the inspectors. After the inspection is done, an inspection report

will be written and a copy of this report will be sent to the applicant. In case of

deficiencies, further details will follow.

8. Stop-clock

The stop-clock starts whenever SFDA issues an Inquiry Form. Inquiries

may be raised at any time from the Phase II Validation to SFDA decision. The

stop-clock ends whenever SFDA receives complete and acceptable responses

from the applicant.

If the applicant faces difficulties in responding to inquiries within the

specified time, applicant should contact SFDA as soon as possible. A drug

application will be considered rejected if the stop-clock time exceeds the SFDA

deadline.

9. SFDA Decision

The final decision is made based on the outcome of SFDA's assessment,

pricing, testing and inspection. The decision can be one of the following:

• Approval: when the drug application has satisfied the registration requirements for quality, safety and efficacy.

• More information is needed: when the drug application has minor deficiencies.

• Rejection: when the drug application has not satisfied the registration requirements.

10. Appeal Process

The applicant will have the right to appeal within 30 days against the SFDA

decision. The relevant guidance will be published soon.

July 2009


4 Structure and Content of Submission

4.1 Structure of Submission:

The SFDA will require all applicants to submit their applications in

accordance to the ICH Common Technical Document (CTD) format. For more

information on the CTD, please refer to appendix D.

The dossier requirements for each application will differ, depending on the

type of application. The table below outlines the CTD Modules required for all

types of applications:

CTD Modules

Type of drug submission

1 2 3 4 5

Generics R1 P2 R P P

New drugs R R R R R

Biologics R R R R R

Radiopharmaceutical R R R R R

Herbal & Health product R P R P P

4.2 Content of Submission

The content will differ from a drug type to another. For more details, see

appendix A.

It is important to remember that the CTD provides a format for an MAA and

does not indicate the content of a dossier and which studies should be performed.

Regional and national requirements may affect the content of the dossier; therefore

the dossier will not necessarily be identical for all regions.

1 R: Required 2 P: Partially required

July 2009


Relevant guidelines, such as Stability guideline, should be followed in

providing the information or studies. For updated guidelines, visit the SFDA

website.

4.3 Module 1: Regional Administrative Information

This module includes the regional required information specific to SFDA, such

as administrative information and certificates. The information to be provided are

identified below and includes:

• 1.0 Cover letter:

The applicant shall include a cover letter for each drug type submission. A

template is provided in appendix J.

• 1.1 Comprehensive table of contents (ToC):

The ToC for the entire submission should list all documents included in

Module 1 and the contents of Modules 2 to 5 to the level of detail or

‘granularity’ defined in the Organization of the Common Technical

Document guidance.

• 1.2 Application Form:

The completed and signed Application Form should be presented in this

section.

• 1.3 Product Information:

This section contains the Summary of Product Characteristics (SPC),

Labeling, Patient information leaflet (PIL) in Arabic and English, Artwork

and the samples. SPC, Labeling and PIL information shall follow the WHO

templates.

• 1.4 Information on the Experts:

The relevant quality, non-clinical and clinical expert declaration(s),

signature(s) and CV(s) must be provided – if applicable, corresponding to

the Overview/Summary submitted in Module 2.3, 2.4 and 2.5 respectively.

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• 1.5 Environmental Risk Assessment:

The application for MA shall be accompanied by an environmental risk

assessment, evaluating any potential risks of the medicinal product to the

environment. Such risk may include those arising from use, storage

disposal and synthesis or manufacture of medicinal products.

• 1.6 Pharmacovigilance:

It shall contain a detailed description of the pharmacovigilance system

including the proof that the applicant has the services of a qualified person

responsible for pharmacovigilance and the necessary means for the

notification of any adverse reaction.

• 1.7 Certificates:

This section contains different type of required certificates such as

Certificate of Pharmaceutical Product (CPP), certificate of analysis and

others.

• 1.8 Pricing:

It should contain the price of the product in countries listed in appendix I.

• 1.9 Responses to questions:

The applicant answers on the SFDA questions shall be placed here. This

part is only applicable to eCTD submissions.

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5 Presentation of the Product File

BOTH the hard-copy (paper-based) and soft-copy (electronic-based) of the

product file shall be submitted by applicants. The hard-copy shall be in the CTD

structure. Whereas, the soft-copy shall be either as:

a. eCTD (appendix D), or

b. An electronic version of the paper-based submission in a specific

structure (appendix B).

5.1 Hardcopy and Softcopy Requirements:

For the hardcopy (paper-submission), the full dossier should be bound into

one volume (ring binder) or more according to the number of pages. For every

300 pages, one volume is needed.

The ring binder specifications:

A4 D-ring 2-ring binder (box file)

Binder Dimensions: width 26.5cm, height 34cm and thickness

7.5cm (26.5 X 34 cm X 7.5 cm)

Label: should contain the following information (figure 2):

1. Reference number (generated from the system)

2. Company name

3. Product trade name

4. Product Generic name

5. Date of submission (DD/MM/YYYY)

6. Number of volumes

7. Type of submission (e.g. new, renew or variation)

If more than one volume is needed, avoid spanning the content of a

Part or a Module of the dossier over two volumes - if applicable.

Tabs should be used to separate the modules

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For the softcopy (electronic-submission), each CD or DVD submitted should

include the following label information, clearly presented and printed on the

media:

• The label should be printed on the CD with the font of 12 Times New

Roman

• The reference number

• The company name

• The product trade name

• The Generic name

• Date of submission (DD/MM/YYYY)

• Number of media units per full set and an indication of the place of the

individual CD/DVD within this set (e.g. 1(4), 2(4)...)

• The submission type of each submission(s) contained on the CD/DVD

(e.g. Initial Application, Variation Type II)

• The sequence number(s) of the eCTD submissions contained on the

CD/DVD (when applicable)

5.2 Number of copies:

Applicants should submit TWO softcopies (identical) and ONE hardcopy of

the product file for all drug submission types. However, in case of NCE,

HG00015-00-00-00 Company ABCDE

Trade Name® Generic Name

01/06/2009 1 of 2

New application

Figure 2: the binder label information

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biologicals and biosimilars only module 1, 2 & 3 are required as a hardcopy

(i.e. the softcopy will contain all the CTD structure).

5.3 MEDIA

The electronic submission may only be submitted in CD or DVD (single or

dual layer). The disc must not be bootable or have auto-start programs. Two

electronic copies are required to be submitted.

Applicant must provide the electronic information on the smallest number

of media units possible, taking into consideration the size of the submission.

Currently both CD-ROM and DVD ISO 9660 are considered an acceptable

media standard.

If more than one CD-ROM or DVD is needed, avoid spanning the content

of a Part or a Module of the dossier over two CD-ROMs or DVDs.

Hard media (e.g. CD, DVD) must be used for the submission of all CTD

documents and eCTDs. It is appreciated that it may be necessary at certain

times in the evaluation process, to submit certain documents via email in the

first instance in order to ensure that the documents are received by SFDA in a

timely manner. However, it is expected to receive an exact copy of the same

submission on hard media as soon as possible, and this electronic submission

will become the formal SFDA record. The electronic submission will be

appropriately processed once received on hard media. The SFDA strongly

advises that eCTD sequences should ONLY be submitted via CD or DVD as

far as possible to ensure that only one communication channel is used.

However, the SFDA will not accept any hardware (laptops, desktops,

thumb drives, hard drive, floppy discs etc.) from applicants in connection with

the electronic submission.

5.3.1 System compatibility:

The electronic submission (as provided) must be directly readable and

usable on SFDA hardware and software.

Although it is the policy of the SFDA to maintain desktop

configurations and IT infrastructure in line with common office standards,

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the electronic information provided in the submission must not only be

readable on the latest operating system, but support a reasonable number of

backward versions of windows operating systems.

5.4 Security

There are various aspects related to security. The physical security of the

submission during transportation/transmission is the responsibility of the applicant.

Once received within the SFDA, security and submission integrity is the sole

responsibility of the SFDA. In this respect, it should be noted that the SFDA will

take appropriate measures to prevent loss, unauthorized duplication and/or access

or theft of regulatory information presented both on paper and electronic media

that are distributed throughout the SFDA.

5.4.1 Password protection:

One-time security settings or password protection of electronic submissions

for security purposes is not acceptable during transportation/transmission

from the applicant to the SFDA.

Applicants should also not include any file level security settings or

password protection for individual files in the electronic submission.

Applicants should allow printing, annotations to the documents, and

selection of text and graphics. The Internal security and access control

processes in the SFDA maintain the integrity of the submitted files.

5.4.2 Virus protection:

The applicant is responsible for checking the submission for viruses.

Checking must be performed with an up-to-date and well-recognized virus-

checker.

After receipt of the submission at the SFDA, a similar internal virus check

will be performed. If a virus is detected it can constitute grounds for refusal

of the electronic submission.

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6 Document Requirements

6.1 Legibility and Size

All documents should be legible. The page size, including tables, shall be

uniform.

6.2 Pagination

The pagination may be sequential for the entire submission or by volume.

Cross-references should include both volume and page number.

6.3 Language

Information and documents supporting a drug application – such as

certificates and approval letters– must be either in Arabic or English. If

documents are neither in Arabic nor English, a translation to English from an

authorized translation office and authentication from the Saudi Embassy in the

COO are required.

6.4 Authentication

Authentication – also known as legalization – refers to the process whereby

the origins of a document are attested. Authentication of documents are made

to SFDA by the Health authority and/or the Ministry of Foreign affairs in the

country of origin, in addition to the Saudi Arabia Embassy or Consulate where

the document was issued.

Certificates that must be authenticated are:

1. CPP or Free Sale Certificate

2. Certificate of analysis

3. Pork-free declaration

4. Price List

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Appendices

Appendix A: Data Requirements

The data requirements for each application will differ, depending on the drug submission type. However, all the required data should be in accordance with the CTD structure.

• In case of New Chemical Entity (NCE), Biologicals and Biosimilars ALL the CTD Modules are required.

• On the other hand the table below outlines the CTD Modules required for Generics (Human and Veterinary) Herbal & Health products3:

G: Generics R: Required H: Herbal & Health products O: Optional4

Section Requirements G H

Module 1 Regional Administrative Information

1.0 Cover letter R R 1.1 Comprehensive Table of content R R 1.2 Application Form R R 1.3 Product Information 1.3.1 Summary of Product Characteristics (SPC) R R 1.3.2 Labeling R R 1.3.3 Patient information leaflet (PIL)

1.3.3.1 Arabic leaflet R R 1.3.3.2 English leaflet R R

1.3.4 Artwork (Mock-ups) R R 1.3.5 Samples R R

1.4 Information on the experts 1.4.1 Quality O O 1.4.2 Non-Clinical O O 1.4.3 Clinical O O

1.5 Environmental Risk Assessment 1.5.1 Non-Genetically Modified Organism (Non-GMO) O O 1.5.2 GMO O O

1.6 Pharmacovigilance 1.6.1 Pharmacovigilance System R R 1.6.2 Risk Management Plan O

1.7 Certificates 1.7.1 CPP or Free-sales R R 1.7.2 Certificate of analysis – Drug Substance R R 1.7.3 Certificate of analysis – Excipients O O 1.7.4 Alcohol-free declaration R R 1.7.5 Pork-free declaration R R

3 Blank fields are not required at this stage or not applicable for that specific drug submission type. 4 Optional means that it might not be needed at this stage

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Section Requirements G H 1.7.6 The diluents and coloring agents in the product formula R R 1.7.7 Patent Information R R

1.8 Pricing 1.8.1 Price list R R 1.8.2 Other documents related O O

1.9 Responses to questions R R

Module 25 Common Technical Document Summaries

2.1 Table of Contents of Module 2-5 2.2 Introduction 2.3 Quality Overall Summary Introduction

2.3.S Drug substance 2.3.S.1 General Information 2.3.S.2 Manufacture 2.3.S.3 Characterization 2.3.S.4 Control of Drug Substance 2.3.S.5 Reference Standards or Materials 2.3.S.6 Container/Closure System 2.3.S.7 Stability

2.3.P Drug Product 2.3.P.1 Description and Composition of the Drug Product 2.3.P.2 Pharmaceutical Development 2.3.P.3 Manufacture 2.3.P.4 Control of Excipients 2.3.P.5 Control of Drug Product 2.3.P.6 Reference Standards or Materials 2.3.P.7 Container/Closure System 2.3.P.8 Stability

2.3.A Appendices 2.3.A.1 Facilities and Equipment 2.3.A.2 Adventitious Agents Safety Evaluation 2.3.A.3 Novel Excipients

2.3.R Regional Information 2.4 Nonclinical Overview 2.5 Overview of the Nonclinical Testing Strategy 2.5.1 Product Development Rationale 2.5.2 Overview of Biopharmaceutics 2.5.3 Overview of Clinical Pharmacology 2.5.4 Overview of Efficacy 2.5.5 Overview of Safety 2.5.6 Benefits and Risks Conclusions

5 Module 2 Should reflect the information provided in modules 3, 4 and 5.

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Section Requirements G H 2.5.7 References

2.6 Non clinical written and tabulated summaries: Pharmacology, pharmacokinetics Toxicology

2.6.1 Introduction 2.6.2 Pharmacology Written Summary

2.6.2.1 Brief Summary 2.6.2.2 Primary Pharmacodynamics 2.6.2.3 Secondary Pharmacodynamics 2.6.2.4 Safety Pharmacology 2.6.2.5 Pharmacodynamic Drug Interactions 2.6.2.6 Discussion and Conclusions 2.6.2.7 Tables and Figures

2.6.3 Pharmacology Tabulated Summary 2.6.4 Pharmacokinetics Written Summary

2.6.4.1 Brief Summary 2.6.4.2 Methods of Analysis 2.6.4.3 Absorption 2.6.4.4 Distribution 2.6.4.5 Metabolism (interspecies comparison) 2.6.4.6 Excretion 2.6.4.7 Pharmacokinetic Drug Interactions 2.6.4.8 Other Pharmacokinetic Studies 2.6.4.9 Discussion and Conclusions 2.6.4.10 Tables and Figures

2.6.5 Pharmacokinetics Tabulated Summary 2.6.6 Toxicology Written Summary

2.6.6.1 Brief Summary 2.6.6.2 Single-Dose Toxicity 2.6.6.3 Repeat-Dose Toxicity 2.6.6.4 Genotoxicity 2.6.6.5 Carcinogenicity 2.6.6.6 Reproductive and Developmental Toxicity 2.6.6.7 Local Tolerance 2.6.6.8 Other Toxicity Studies (if available) 2.6.6.9 Discussion and Conclusions 2.6.6.10 References

2.6.7 Toxicology Tabulated Summary 2.7 Clinical Summary

2.7.1 Summary of Biopharmaceutic and Associated Analytical Methods 2.7.1.1 Background and Overview 2.7.1.2 Summary of Results of Individual Studies 2.7.1.3 Comparison and Analyses of Results Across Studies 2.7.1.4 Appendix

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Section Requirements G H 2.7.2 Summary of Clinical Pharmacology Studies

2.7.2.1 Background and Overview 2.7.2.2 Summary of Results of Individual Studies 2.7.2.3 Comparison and Analyses of Results Across Studies 2.7.2.4 Special Studies 2.7.2.5 Appendix

2.7.3 Summary of Clinical Efficacy 2.7.3.1 Background and Overview of Clinical Efficacy 2.7.3.2 Summary of Results of Individual Studies 2.7.3.3 Comparison and Analyses of Results Across Studies

2.7.3.3.1 Study Populations 2.7.3.3.2 Comparison of Efficacy Results Across All Studies 2.7.3.3.3 Comparison of Results in Sub-Populations

2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations

2.7.3.5 Persistence of Efficacy and/or Tolerance Effects 2.7.3.6 Appendix

2.7.4 Summary of Clinical Safety 2.7.4.1 Exposure to the Drug

2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies 2.7.4.1.2 Overall Extent of Exposure 2.7.4.1.3 Demographic and Other Characteristics of Study Population

2.7.4.2 Adverse Events 2.7.4.2.1 Analysis of Adverse Events by Organ System or Syndrome 2.7.4.2.2 Narratives

2.7.4.3 Clinical Laboratory Evaluations 2.7.4.4 Vital Signs, Physical Findings, Observations Related to Safety 2.7.4.5 Safety in Special Groups and Situations

2.7.4.5.1 Intrinsic Factors 2.7.4.5.2 Extrinsic Factors 2.7.4.5.3 Drug Interactions 2.7.4.5.4 Use in Pregnancy and Lactation 2.7.4.5.5 Overdose 2.7.4.5.6 Drug Abuse 2.7.4.5.7 Withdrawal and Rebound 2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment

of Mental Ability

2.7.4.6 Post-Marketing Data 2.7.4.7 Appendix

2.7.5 References 2.7.6 Synopses of Individual Studies

Module 3 Quality

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Section Requirements G H 3.1 Table of Contents of Module 3 R R 3.2 Body of data

3.2.S Drug Substance 3.2.S.1 General Information

3.2.S.1.1 Nomenclature R R 3.2.S.1.2 Structure R R 3.2.S.1.3 General Properties R R

3.2.S.2 Manufacture 3.2.S.2.1 Manufacturer(s) R R 3.2.S.2.2 Description of Process and Process Controls R O

3.2.S.2.3 Control of Materials R O

3.2.S.2.4 Control of Critical Steps and Intermediates R O 3.2.S.2.5 Process Validation and/or Evaluation R O 3.2.S.2.6 Manufacturing Process Development R O

3.2.S.3 Characterization 3.2.S.3.1 Elucidation of Structure and Other Characteristics R O 3.2.S.3.2 Impurities R R

3.2.S.4 Control of Drug Substance 3.2.S.4.1 Specifications R O 3.2.S.4.2 Analytical Procedures R O 3.2.S.4.3 Validation of Analytical Procedures R O 3.2.S.4.4 Batch Analyses R R 3.2.S.4.5 Justification of Specification R O

3.2.S.5 Reference Standards or Materials R O 3.2.S.6 Container/Closure Systems R O 3.2.S.7 Stability

3.2.S.7.1 Stability Summary and Conclusions R O 3.2.S.7.2 Post-approval Stability Protocol and Commitment R O 3.2.S.7.3 Stability Data R O

3.2.P Drug Product 3.2.P.1 Description and Composition of the Drug Product R R 3.2.P.2 Pharmaceutical Development

3.2.P.2.1 Components of the Drug Product 3.2.P.2.1.1 Drug substance R R 3.2.P.2.1.2 Excipients R R

3.2.P.2.2 Drug Product 3.2.P.2.2.1 Formulation Development O O 3.2.P.2.2.2 Overages R R 3.2.P.2.2.3 Physiochemical and Biological Properties R R

3.2.P.2.3 Manufacturing Process Development R R 3.2.P.2.4 Container Closure System R R 3.2.P.2.5 Microbiological Attributes R R 3.2.P.2.6 Compatibility O O

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Section Requirements G H 3.2.P.3 Manufacture

3.2.P.3.1 Manufacturer(s) R R 3.2.P.3.2 Batch Formula R R 3.2.P.3.3 Description of Manufacturing Process and Process Controls R R 3.2.P.3.4 Controls of Critical Steps and Intermediates R O 3.2.P.3.5 Process Validation and/or Evaluation R O

3.2.P.4 Control of Excipients 3.2.P.4.1 Specifications R R 3.2.P.4.2 Analytical Procedures R R 3.2.P.4.3 Validation of Analytical Procedures R R 3.2.P.4.4 Justification of Specifications R R 3.2.P.4.5 Excipients of Human or Animal Origin R R 3.2.P.4.6 Novel Excipients R R

3.2.P.5 Control of Drug Product

3.2.P.5.1 Specifications R R 3.2.P.5.2 Analytical Procedures R R 3.2.P.5.3 Validation of Analytical Procedures R R 3.2.P.5.4 Batch Analyses R R 3.2.P.5.5 Characterization of Impurities R R 3.2.P.5.6 Justification of Specifications R R

3.2.P.6 Reference Standards or Materials R R 3.2.P.7 Container/Closure System R R

3.2.P.8 Stability

3.2.P.8.1 Stability Summary and Conclusions R R 3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitments R R 3.2.P.8.3 Stability Data R R

3.2.A Appendices

3.2.A.1 Facilities and Equipment O O 3.2.A.2 Adventitious Agents Safety Evaluation O O 3.2.A.3 Excipients R R

3.2.R Regional Information 3.2.R.1 Alcohol Content Declaration R R 3.2.R.2 Porcine/Pork – content/origin R R 3.2.R.3 The diluents and coloring agents in the product formula

3.3 Literature References R R

Module 4 Non-Clinical Study Reports

4.1 Table of Contents of Module 4 R 4.2 Study Reports

4.2.1 Pharmacology 4.2.1.1 Primary Pharmacodynamics R 4.2.1.2 Secondary Pharmacodynamics R

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Section Requirements G H 4.2.1.3 Safety Pharmacology R 4.2.1.4 Pharmacodynamic Drug Interactions R

4.2.2 Pharmacokinetics 4.2.2.1 Analytical Methods and Validation Reports R 4.2.2.2 Absorption R 4.2.2.3 Distribution R 4.2.2.4 Metabolism R 4.2.2.5 Excretion R 4.2.2.6 Pharmacokinetic Drug Interactions R 4.2.2.7 Other Pharmacokinetic Studies R

4.2.3 Toxicology R 4.2.3.1 Single-Dose Toxicity R 4.2.3.2 Repeat-Dose Toxicity R 4.2.3.3 Genotoxicity

4.2.3.3.1 In vitro Studies 4.2.3.3.2 In vivo Studies

4.2.3.4 Carcinogenicity 4.2.3.4.1 Long Term Studies 4.2.3.4.2 Short or medium term studies 4.2.3.4.3 Other studies

4.2.3.5 Reproductive and Development Toxicity 4.2.3.5.1 Fertility and Embryonic Development 4.2.3.5.2 Embryo-Fetal Development 4.2.3.5.3 Pre- and Post-natal Development & Maternal Function 4.2.3.5.4 Offspring, Juvenile, Second & Third-Generation Studies

4.2.3.6 Local Tolerance 4.2.3.7 Other Toxicity Studies

4.2.3.7.1 Antigenicity 4.2.3.7.2 Immunogenicity 4.2.3.7.3 Mechanistic Studies (not included elsewhere) 4.2.3.7.4 Dependence 4.2.3.7.5 Metabolites 4.2.3.7.6 Impurities 4.2.3.7.7 Other

4.3 Literature References O O

Module 5 Clinical Study Reports

5.1 Table of Contents of Module 5 R R 5.2 Tabular Listing of All Clinical Studies R R 5.3 Clinical Study Reports

5.3.1 Reports of Biopharmaceutic Studies 5.3.1.1 Bioavailability (BA) Study Reports R O 5.3.1.2 Comparative BA & BE Study Reports R O

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Section Requirements G H 5.3.1.3 In vitro/In vivo Correlation (IV/IVC) study reports R O 5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human studies R R

5.3.2 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials

5.3.2.1 Plasma Protein Binding Study Reports O 5.3.2.2 Reports of Hepatic Metabolism and Drug Interactions studies O 5.3.2.3 Reports of Studies Using other Human Biomaterials O

5.3.3 Reports of Human Pharmacokinetic Studies

5.3.3.1 Healthy Subject PK and Tolerability

5.3.3.2 Patient PK and Initial Tolerability

5.3.3.3 Intrinsic Factor PK Study Reports

5.3.3.4 Extrinsic Factor PK Study Reports 5.3.3.5 Population PK Study Reports

5.3.4 Reports of Human Pharmacodynamic (PD) Studies 5.3.4.1 Healthy Subject PD and PK/PD Study Reports 5.3.4.2 Patient PD and PK/PD Study Reports

5.3.5 Reports of Efficacy and Safety Studies 5.3.5.1 Study reports of Controlled Clinical Studies pertinent to the claimed

Indication

5.3.5.2 Study reports of Uncontrolled Clinical Studies 5.3.5.3 Reports of Analyses of Data from More than One Study 5.3.5.4 Other Study Reports

5.3.6 Reports of Post-Marketing Experience R R 5.3.7 Case Report Forms and Individual Patient Listings R R

5.4 Literature References R R

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Appendix B: Electronic Version of the PaperBased Submission

The electronic version of the paper-based submission is the submission of electronic information by applicants to support a marketing authorization application.

It is formatted as a simple set of electronic files and folders organized into module folders as per the CTD structure.

How to create an electronic version?

1. Create a folder and name it as:

“Product name – Reference No.”.

For example, “Drug AAA – HG-00253-00-00-00”

2. Inside that folder, create 5 new folders and name it from m1 to m5 (figure 3).

3. Copy the related documents of module 1 and paste it in the folder m1 (figure 4).

4. Repeat step 3 for all modules.

5. After finishing, burn the product file to a CD or a DVD and name it as in step 1.

Figure 3: View of the product file after creation of m1 to m5

Figure 4: View of the product file after creation of m1

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Appendix C: File Formats

General requirements:

Generally, the relevant information must be structured according to the requirements of the Common Technical Document (CTD). The following files formats are accepted:

• PDF

• XML

• Word and RTF6 file formats, but only in addition to a PDF-file of the same document.

• For graphics: Joint Photographic Experts Group (JPEG), Portable Network Graphics (PNG), Scalable Vector Graphics (SVG) or Graphic Interchange Format (GIF).

Please refer to the Status of the Common Technical Document Guidelines:

http://www.ich.org/cache/compo/276-254-1.html

Portable Document Format:

PDF is an open, de facto, published format created by Adobe Systems Incorporated (http://www.adobe.com). It is not necessary to use a product from Adobe or from any specific company to produce PDF documents. PDF is accepted as a standard for documents defined in this specification. The following recommendations support the creation of PDF files that agencies can review effectively. To ensure that PDF files can be accessed efficiently, PDF files should be no larger than 100 megabytes. Optimize PDF files for fast web view.

The following points can be made in relation to PDF files:

• Files must be legible with PDF version 1.4

• PDF files produced from an electronic source document are highly preferred over PDF files produced from scanned paper, since those 'electronic' PDF files provide the maximum functionality to the reviewers in terms of search and print capabilities, and copy and paste functionality. The overviews/summaries in the CTD Module 2 should always be generated from an electronic source document.

• If scanning is unavoidable, readability and file size must be balanced; the following is recommended: resolution 300 dpi (photographs up to 600 dpi), avoid grayscale or color where possible, use only lossless compression techniques.

6 Rich Text Format (often abbreviated RTF) is a document file format

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• If colors other than black are used, the colored pages must be tested on a black and white printer for acceptable reproduction and legibility prior to submission.

• Print area for pages must fit on an A4 sheet of paper; margins must allow binding in multi-ring binders without affecting readability.

• Landscape-oriented tables must automatically appear in landscape on screen.

Indexing PDF Documents:

The software installed in the SFDA for reviewing use full text indexes to help find specific documents and/or search for text within documents. When a document or group of documents is indexed, all words and numbers in the file and all information stored in the Document

Information fields are stored in special index files that are functionally accessible using the search tools available in Acrobat. Portions of a document that are imaged are not indexed.

These full text indexes should not be confused with a table of contents.

Extensible Markup Language (XML):

XML is developed by a working group of the World Wide Web Consortium (W3C). It is an open-source language developed to improve on previous mark-up languages including Standard Generalized Markup Language (SGML) and Hypertext Markup Language (HTML).

Additional details on XML can be found in the ICH eCTD Specification Document.

Text Searchable Files:

Applicants are requested to ensure that all submissions contain the maximum amount of text searchable content. Documents with searchable text will aid the assessor, or any other user, in searching for specific terms and also in copying and pasting information into another document, such as an assessment report. The SFDA recognizes that not all documents need to be text searchable. This appendix provides some guidance about what must be text searchable and the ways to ensure that files are created appropriately.

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Documents that must always be text searchable:

The PDF should be produced wherever possible from a text source, such as MS Word, but if sourced from a scanned original then they must be OCR’d.

• Key administrative documents in Module 1 including, the cover letter, application form, SPC, labeling documents

• Any document in Module 2 of the submission (QOS, Preclinical Overview and Summaries, Clinical Overview and Summaries).

• The main body of text of Periodic Safety Update Reports (PSURs)

• The main body of text of Risk Management Plans

• The main body of text and main tables in any preclinical or clinical report required to support the main claim of the application.

• The main body of text in any reports, methods, analytical procedures, etc. supplied in Module 3 of the submission

Documents that do not need to be text searchable:

The PDF should be produced wherever possible from a text source, such as MS Word, but if sourced from a scanned original then there is no need for OCR.

• Any original Certificate of Pharmaceutical Product

• Any original Certificate that confirm that the product is free from BSE/TSE

• Any original GMP certificate

• Any original certificate of analysis

• Any manufacturer’s licenses

• Any certificates of suitability

• Any Manufacturing Authorization

• Any literature references sourced from journals, periodicals and books (except when these are used in a bibliographic application so support the main claims of the application).

• Any page with a signature that does not contain other information key to the understanding of the submission

• Applicants should consider providing signatures on separate pages from key text in reports, overviews, etc.

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Use of Electronic Signatures:

The use of advanced electronic signatures (digital signatures) will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies, particularly for authentication of electronic submissions and documents contained therein. Saudi Arabia is therefore developing a long-term strategy to implement digital signatures. Currently however, the use of digital signatures for electronic submissions within the kingdom of Saudi Arabia is not fully supported and digital signatures should therefore not be used.

Handling Empty or Missing eCTD sections:

For new applications (including generic applications), detailed statements justifying the absence of data or specific CTD sections should be provided in the relevant Quality Overall Summary and/or Non-Clinical/Clinical Overviews (Module 2.3, 2.4, 2.5). Note that placeholder documents highlighting 'no relevant content' should not be placed in the eCTD structure, as these would create a document lifecycle for non-existent documents, and unnecessary complication and maintenance of the eCTD.

NB: for a generic application, note that there is no need to provide a justification for content that is typically absent.

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Appendix D: ICH Common Technical Document

Common Technical Document (CTD)

The Common Technical Document is an internationally agreed format for the preparation of a marketing authorization (MA) that is to be submitted to the regulatory authorities in the three ICH regions (USA, EU and Japan) and in some other countries and regions. The CTD provides a common format for the preparation of a well structured dossier. It uses a modular framework described in ICH Topic M47. This guidance document should be read in conjunction with the most recent version of the ICH CTD guidance documents.

It is important to remember that the CTD provides a format for an MAA and does not indicate the content of a dossier and which studies should be performed. Regional and national requirements may affect the content of the dossier; therefore the dossier will not necessarily be identical for all regions.

The CTD is applicable for all types of products (new chemical entities, biologicals, herbals etc.)

The CTD is organized into five modules (figure 4). Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions.

• Module 1: Administrative Information and prescribing Information

• Module 2: Common Technical Document Summaries

• Module 3: Quality

• Module 4: Non-Clinical Study Reports

• Module 5: Clinical Study Reports

7 http://www.ich.org/

July 2009


Figure 5: Diagrammatic representation of the organization of the ICH CTD8

eCTD

The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.

The eCTD is an electronic version of the CTD. The structure, folder and file names correspond to those of the CTD. As a submission format, however, it contains additional technical components which enable the lifecycle of individual files in the application, and the lifecycle of the product itself, to be managed.

An eCTD has the following components: Folder structure, Contents (files) and XML backbone.

The folder structure has a hierarchical organization reflecting that of the CTD, and it holds the scientific and technical contents of the eCTD (divided into many files which are the same as those in the non-eCTDs, usually in PDF format).

8 Source: adapted from the ICH guideline……

July 2009


The XML backbone is recognisable as ‘index.xml’ at the root level of the submission folder of an eCTD and provides two useful functions:

• It provides a hyperlinked table of contents of the entire submission when viewed in a web browser with a suitable style sheet

• It provides descriptive information (‘metadata’) on the files that make up the actual contents of the eCTD.

July 2009


Appendix E: Target Performance Timelines

Target performance timelines from the date of acceptance to SFDA decision, excluding the stop-clock for various submission types are as follows:

The timelines stated (in working days) are subject to change.

Process Total Performance Target

Marketing Authorization Application for Generics 165 days

Marketing Authorization Application for NCEs 290 days

Marketing Authorization Application for Biologicals 290 days

Marketing Authorization Application for Radiopharmaceuticals

290 days

Marketing Authorization Application for Veterinary drugs

195 days

Marketing Authorization Application for Herbal products

155 days

Renewal of Marketing Authorization 30 days

Variation to a Marketing Authorization Type I: Notifiable Change

30 days

Variation to a Marketing Authorization Type II: Supplemental to MA

165 days

July 2009


Appendix F: Required Quantities of Samples

The following table shows the required quantities of the samples for different sample types.

No. Sample Type Volume Quantity

1 Tablets - 100 tablets

2 Capsule - 100 capsules

3 Syrup > 250 mL 6-8 packs

4 Solution 250-500 mL 6 packs

5 Solution 5-10 L 2 packs

6 Antiseptic 1 L 6 packs

7 Antiseptic 5 L 2 packs

8 Drops 15 mL 15 packs

9 Ointment & Creams - 15 packs

10 Raw materials - 2 packs

12 Ampoules, Vials & PFS 0.5 mL 25 packs

13 Ampoules, Vials & PFS 1 mL 20 packs

14 Ampoules, Vials & PFS 2-5 mL 15 packs

15 Bottles ≥ 5 mL 6 bottles

16 BCG vaccine - 50 packs

17 Blood bags - 8 bags

18 Infusion sets - 6 packs Notes:

• The SFDA has the right to ask for additional quantities as needed.

• The SFDA has the right to ask for analysis tools and standard materials as needed.

July 2009


Appendix G: References

SFDA Reference Documents:

• Regulatory Framework for Drug Approvals (version 4)

• Bioequivalence Guidelines

• Stability Guidelines

• SPC, Labeling and PIL guidelines (published soon)

• SA Module 1 Specification (published soon)

The latest versions of SFDA's guidance documents are available on the website at the following address:

http://www.sfda.gov.sa/En/Drug/Topics/Regulations+-+Guidelines.htm

ICH Reference Documents:

M4 : The Common Technical Document

• Organization of The Common Technical Document for the Registration of Pharmaceuticals for Human Use

• Implementation Working Group – Questions & Answers (R3)

• Electronic Common Technical Document Specification (version 3.2)

• The Common Technical Document for The Registration of Pharmaceuticals for Human Use: Quality – M4Q(R1)

• The Common Technical Document for The Registration of Pharmaceuticals for Human Use: Safety – M4S(R2)

• The Common Technical Document for The Registration of Pharmaceuticals for Human Use: Efficacy – M4E(R1)

These documents and more are found at the ICH website at the following address:

http://www.ich.org/

July 2009


Appendix H: Contact Address

Saudi Food and Drug Authority – Drug Sector

3292 Northern Ring Road – An nafal District

Riyadh 13312 – 6288

Kingdom of Saudi Arabia

Tel: +966-1-275- 9222 extensions: 1302 or 5302

Fax: +966-1-275-7195

e-mail: [email protected]

July 2009


Appendix I: Price List

Product trade name

Package size

Strength/unit Ex-Factory price

Dosage form COO Wholesale

price

Company name COO public

price

Nationality CIF to SA

The other prices in the countries where the product is marketed

No. Country COO Currency Package

size Ex-factory

price CIF price

Public price

1 Algeria 2 Australia 3 Argentina 4 Bahrain 5 Belgium 6 Canada 7 Cyprus 8 Denmark 9 Egypt

10 Finland 11 France 12 Germany 13 Greece 14 Netherlands 15 Hungary 16 Ireland 17 Italy 18 Japan 19 Jordan 20 Kuwait 21 New Zealand 22 Norway 23 Oman 24 Portugal 25 Lebanon 26 Spain 27 Sweden 28 Switzerland 29 U.A.E. 30 U.K.

July 2009


Appendix J: Cover Letter

אאאאאאאא א

،،،אא

،אאאאאאאאW

אא Trade Name

אא Generic Name

א Strength

אא Dosage Form

אא manufacturer

אא Marketing Company

،،،אאא

KKKKKKKKKKKKKKKKKKKKKKKK

July 2009


Appendix K: Laboratory Samples Form

אא Trade Name

אא Generic Name

א Strength

אא Dosage Form

א Storage condition

א Sample Quantity

אא Marketing Company

אא Manufacturer

אא Expiry Date

א Batch No.

July 2009


Appendix L: Abbreviation and Acronyms

COO Country of Origin

CPP Certificate of Pharmaceutical Product

CTD Common Technical Document

MA Marketing Authorization

MAA Marketing Authorization Application

NCE New Chemical Entity

PFS Prefilled syringe

PIL Patient Information Leaflet

SA Saudi Arabia

SFDA Saudi Food and Drug Authority

SPC Summary of Product Characteristics