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 and territories 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-CONSULT-D2
ec [dot] europa [dot] eu (SANTE-CONSULT-D2[at]ec[dot]europa[dot]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 / territory |
Date of request |
Equivalence assessment status |
|
Taiwan* |
8 December 2021 |
Adopted, Commission Implementing Decision (OJ L, 10.11.2023) |
|
Canada |
1 October 2018 |
Adopted, Commission Implementing decision (OJ L 24/37, 26.01.2023) |
|
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) |
* The list contains countries and territories. It is not limited to countries recognised by the EU.
