TOPRA IN SWITZERLAND

Authorisation of medicinal products already authorised in foreign countries (Article 13, TPA)

U.Hopff 18.10.2011Regulatory Affairs Manager

Vifor Pharma

The Law

„If a medicinal product or procedure is alreadyauthorized in a country with a comparablecontrol system for medicinal products, the

results of tests carried out for this purpose shallbe taken into account“

Paragraph 13 TPA

Spirit and Purpose of the Law

To take into account the results of tests carried out by countrieswith comparable control system for medicinal products:

AUSTRALIA, CANADA, EU and EFTA Member States, JAPAN, NEW ZEALAND, SINGAPORE, USA

To treat marketing authorisation applications fast and rational

Use resources of SwM well-directed and risk based

Reduce processing time for authorisation and cost by a third

Swissmedic decides whether Art. 13 can be applied

Art. 5a VAM: The results of reference authority are taken intoaccount for marketing authorisations and changes if:

a. The submitted documentation including modifications from the foreign procedure is not older than 5 years.

b. All results of examination and decisions from theforeign procedure are submitted.

c. Documents include Swiss specific requirementsespecially for product information.

d. Documents in Switzerland‘s official language or in English.

Legal Basis

Legal Basis

Art. 5b VAM: Medicinal products with known active substances (KAS)

1. KAS by foreign authority but not CP or FDAExamination of evaluation report but might carry out ownscientific evaluation if:

Prior rejection or withdrawl in Switzerland Rejection by foreign authorities

2. KAS with CP or FDA authorisationSwM refrains from examination of the evaluation report.Analysis of background, context, PhIL, safety signalsexcept:

Material differences Previous rejection or withdrawal in Switzerland

Art. 5c VAM: Medicinal products with new active substances and their newindications (NAS)

Generally Swissmedic carries out own evaluation may howeverreduce assessment in justified cases:

Orphan drugs

Life-threatening / debilitating disease

Considerable therapeutic advantage

Central EMA or FDA authorisation

Legal Basis

Legal Basis

Art. 5d VAM: Parallel procedureSwitch from national procedure to an evaluation according toparagraph 13

Status of application for authorisation in foreigncountries

As soon as EMA issues recomendationsubmit corresponding request

Documentation requirements

CTD Module 2-5 submitted to the reference authority

+CTD Moudule 1 submitted to the reference authority

+CTD Module 1 according to Swiss requirements

Confirm that the documentation including modifications and/oradditions since the decision by the foreign authority is identical .

Documentation submitted to thereference authority

All results of examination and decisions on the part of the reference authority including correspondence

EU Responses to Questions, EU Assessment Report, EU Decision, FDA Decision (incl. FDA Assessment Report)

Modifications and or additions since the decision by the foreign authority

Information regarding safety signals

GLP/GMP/GCP confirmation

Paediatric Investigation Plan (PIP)

Drug Master File (DMF)

Documentation requirements

SWISS MODUL 1

Administrative data Request of Article 13 TPA applicationTick box on application form

Checklist for formal control relating to Article, 13 TPAConfirm that requirements are fulfilled

Product Information Swiss specific information (e.g. pregnancy, storageinstructions, language requirements)Θ word-by word acceptance of the reference countries SPC not possible except EMA decision (EU-SmPC )

Documentation requirements

What differences between the foreign andapplication to SwM are allowed?

Differences of the place of manfacture of the finished product

Differences related to batch release

Differences related to primary packaging

Differences to quality control

Differences to the product designation

Formal Control

Guidances andDocuments:

Administrative OrdinanceAuthorisation of medicinalproduct already authorised in foreign countries (Paragraph 13 TPA)

Guidance on applicationsaccording to Paragraph 13 TPA foreCTD applications

Formal Control Art. 13 andformal control Art 13 CTD

www.swissmedic.ch

Documents for eCTDsubmissions

Swiss Module 1 + Reference dossier + Correspondence

Initial Swiss eCTD sequence contains only Swiss Modules 1

If accepted according to Art. 13 then submit consolidationsequence (incorporate Module 2-5 in Swiss eCTD)

Time Table for RX-registrations

(approximately)Standard-verfahren

nach Art. 13 (CP)*

nach Art. 13 (DCP/MRP)**

Administrative preparationby MAH

30 50 50

SwM: formal control 30 30 30

Marketing Authorisation 300 200 200-290

BAG:Preparation by MAH 30 30 30

BAG: Decision andadmission to SL

120 120 120

Total to Launch 510 430 430-520

Time Table Paragraph 13 TPA

* CP 297 + clock stop / Date of Comission Decision**MRP 440 + clock stop /Date of Day 90**DCP 250 + clock stop /Date of MA in RMS

Responsibilities after authorisation

Conditions that are imposed by the reference authorities are that havenot yet been fulfilled at the time of authorisation are also imposed bySwissmedic

Decisions taken by the reference authorities concerned the fulfilment ofconditions must be forwarded to the Agency

All relevant information such as correspondence in relation to marketsurveillance after authorisation in a reference country

Examples and possible issues atsubmission

Identical documentation not always possible:−e.g. FDA NDA format is not identical with CTD format, international standards BP, USP not always identical withPh.Eur./Ph.Helv requirements.

Timelines unclear:−e.g. procedure lasted more than 2 years

Swissmedic did not approve indication in previous applicationleads to own evaluation based on earlier concern.

Know active substance with slightly different indication in thereference country.

Safety concern and other questions by Swissmedic

Questions ?