+39 0677209020 info@direnzo.biz

Brexit, AIFA on non compliant MAs

Following the exit of the United Kingdom from the European Union, the Italian Medicine Agency has informed that for medicinal product with MA holder, PSMF, QPPV, batch control and release sites for the finished product still located in the UK, and for which variations were not submitted nor pertinent actions were taken to ensure the compliance with the European regulations, new batches cannot be marketed anymore.

In particular, the Italian Agency reminded that in order to correct these situations and ensure the release of new batches according to the European norms (Directive 2001/83/EC), any corresponding application of MA transfer/type IAIN/IB/II variation/update of the article 57 database for the QPPV and/or PSMF shall be submitted within 1 month from the date of the communication and/or the corresponding type IA variation should be sent no later than 2 months from the date of the communication.

In the case it is not possible to meet these requirements, an update shall be sent to the dedicated e-mail address (exemption-brexit@aifa.gov.it) within 1 month from the date of the communication, indicating the name of the product and the national MA or MRP/DCP number.

In case of no submission of the relevant variation, regulatory measures will apply, such as the MA suspension or revocation, or a ban to supply the medicinal product.

The product batches already controlled and released before the end of the transition period (31 December 2020) can remain on the EU/EEA market.

Any change requested for the medicinal product, such as the removal of the importation sites, control and batch release sites located in Great Britain, when there are alternative sites in the territory of the European Union/EEA/UK (NI), or the change of local  epresentatives, if still located in the United Kingdom), are still valid.

These variations shall be submitted as soon as possible, and however not beyond 12 months form the implementation, except for the procedures for which Ireland, Cyprus, Malta and Northern Ireland granted an exemption, however applying for a maximum of 12 months, until the end of 2021.

Foto di PublicDomainPictures da Pixabay