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Importation of active substances - Listing of third countries

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The Falsified Medicines Directive introduces EU-wide rules for the importation of active substances. These can only be imported if they are accompanied by written confirmation from the competent authority of the exporting country that attests that the standards of good manufacturing practice and control of the manufacturing site are equivalent to those in the EU. This requirement is waived for certain third countries listed by the Commission.

How to apply for listing?

You should submit your request to be included in the list by letter addressed to the Director-General of DG SANTE accompanied by the documents listed below.

Directorate-General for Health and Food Safety (DG SANTE)
European Commission, office B232 07/095
B-1049 Brussels (Belgium)

An electronic copy of the application, including all supporting documents, should be sent to sante-pharmaceuticals-b4@ec.europa.eu.

The information to be submitted with the listing request is here.

Procedures and time taken for conducting the equivalence assessment

The equivalence assessment is based on the elements of the JAP checklist relevant to API manufacture. The request can take several months to process.

Status of current and past applications

Country

Date of request

Equivalence assessment ongoing

Canada

1 October 2018

Equivalence assessment ongoing

South Korea

22 January 2015

Adopted, Commission Implementing Decision (OJ L 126/70, 15.05.2019)

New Zealand

26 June 2013

Assessment on hold pending clarification of the scope of the existing MRA.

United States

17 January 2013

Adopted, Commission Implementing Decision (OJ L 169/71, 21.06.2013)

Japan

6 December 2012

Adopted, Commission implementing Decision (OJ L 152/52, 5.6.2013)

Brazil

4 October 2012

Adopted, Commission implementing Decision (OJ L 171/23, 2.7.2015)

Singapore

17 September 2012

No listing for the moment (the relevant Singapore legislation provides for a non-mandatory GMP certification scheme). Contacts ongoing. In the meantime, Singapore issues written confirmation.

Australia

18 September 2012

Adopted, Commission implementing Decision (OJ L 113, 25.4.2013)

Israel

9 May 2012

3 september 2014

Adopted, Commission implementing Decision (OJ L 171/23, 2.7.2015)

Switzerland

4 April 2012

Adopted, Commission implementing Decision (OJ L 325, 23.11.2012)