News about GMP/cGMP

18.09.2016

Importation of APIs: Version 7 of Q&A Document

The European Commission has published a revised Version 7 of its Question and Answers Document that sets out frequently asked questions on importation of active substances for medicinal products for human use. This document is continuously updated and further supplemented.

With this new version, Q&A 35 was added to clarify the requirements in case of importation of active substances released for sale before the expiration date of their written confirmation but only imported into the EU once the written confirmation had been expired. The detailed answer can be summarized to the extent that

“It is legitimate to consider that the guarantees of equivalence provided by the written confirmation apply to any API batch in the scope of the written confirmation which was released for sale within the period of validity of the written confirmation, even if not exported in that time period.”

This is acceptable provided that the data unequivocally proves the whole process and that a solid justification of why a valid written confirmation is not available is given. Furthermore, a minor editing of Q&A 10A and 29A was carried out and Q&A 29B was deleted.