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MHRA GDP SymposiumNovotel London West, London

8 & 10 December 2015

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Export and Introduction

Presented by: Cheryl Blake, Senior GDP Inspector

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Export and Introduction.

WHICH – activities are covered by a WDA(H)

WHAT – must we consider when exporting

products

WHEN – is a product defined as being

‘introduced’ and when is it ‘imported’

HOW – are products introduced to the EEA

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WDA(H) – Authorised activity definitions.

According to Article 1(17) of Directive 2001/83/EC,

wholesale distribution of medicinal products is ‘all

activities consisting of procuring, holding, supplying

or exporting medicinal products’.

Procure Hold Supply Export

BUY STORE SELL OUTSIDE EEA

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Medicinal Products - Ranges.

‘with a Marketing Authorisation in EEA

country(s)’.

‘without a Marketing Authorisation in

the EEA and intended for the EEA

market’.

‘without a Marketing Authorisation in

the EEA and intended for exportation’.

This final category defines ‘Introduced’

Medicinal products.

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Trade with a fellow member state is not

defined as Export.

Medicinal product should stay in the

licensed supply chain. – Are you

delivering to a site which is licensed to

‘Hold’ that product?

Use of Incoterms such as EXW (Ex Works)

FCA (Free Carrier) DAT (Delivered at

Terminal) or FOB (Free on Board) do not

relieve the seller of all responsibility.

Export: some considerations

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What will inspectors expect?

Evidence of an unbroken supply chain.

Evidence of customer qualification.

Evidence of suitable shipment methods.

Export documentation specifically the

entry made via CHIEF (the Customs

Handling of Import and Export Freight

system).

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Introduction to Introduction.

‘introduced’ medicines are sourced from a non-

EEA country for the sole purpose of export to a

(usually different) non-EEA country.

They will not have a marketing authorisation

within the EEA.

Frequently and wrongly referred to as ‘Import

for Export’.

Misnomer – technically these items are not

imported as they do not enter ‘free circulation’

within the EEA.

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What is the difference.

Importation of product manufactured in a

third country for use in the EEA is a GMP

activity requiring a Manufacturing Licence

(either MIA or MS dependent upon product).

This activity requires Q.P. release of product.

Introduction of a product manufactured in a

third country to the EEA (either physically or

financially) may not be placed on the market.

This is a GDP activity.

The intention is crucial and should be

reflected by the customs procedure code.

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What is a Customs Procedure Code?

The CPR is entered in box 37 of the C88

It is a 7 digit code made up from 3 groups

of numbers.

Where the digits are 40 to 49 inclusive,

this indicates goods have been entered to

‘free circulation’ and implies import.

It is crucial that your shipping department

or freight forwarder understands and

reflects your intention correctly.

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What documentation is it necessary to retain?

Import form C88 stating the correct CPC code

for the procedure.

Corresponding Export form C99 Discharge of

Goods to 3rd Country.

Tariff codes and quantities should match on

both sets of documents.

Certificate of Origin obtained from

International Chambers of Commerce. This

must reflect the non EEA country where the

majority of manufacturing occurred.

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Facilitating and invoicing trade between two

third countries.

Any trade between two non EEA countries

being invoiced from a member state will be

subject to the GDP guidelines in their entirety.

Therefore it is necessary for the supplying

WDA(H) holder to demonstrate (amongst other

requirements) that transportation has been

compliant with GDP guidelines.

Financial introduction. Product has been

procured and supplied by a Member State.

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Regulatory Position.

To accord with Regulation 44(1) of the Human

Medicines Regulations the holder of a wholesale

distribution authorisation may not obtain supplies of

medicinal products from anyone except:

(a) the holder of a manufacturer’s licence or

wholesale dealer’s authorisation in relation to products

of that description; or

(b) a person who holds an authorisation granted by

another EEA State authorising the manufacture of

products of that description or their distribution by way

of wholesale dealing.

Therefore these requirements will prohibit the sourcing

of medicines via a company in a third country.

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Summary.

Trade within Europe is not defined as Export.

Import and Introduction are different activities.

Ensure correct procedure codes are used.

These describe the Intent.

Upon Export, certificates of origin must reflect

the correct country of origin (manufacture).

Where title of medicinal product is transferred

outside of the EEA and back in, this is

considered Import and therefore requires a

manufacturing licence.

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Thank you for your attention.

Cheryl Blake

Senior GDP Inspector

Inspection, Enforcement and Standards

Medicines and Healthcare products Regulatory Agency

+ 44 203 080 6050

cheryl.blake@mhra.gsi.gov.uk.

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