20/21 April 2021
Again, two of the Q&A documents relating to the "centralised procedure" have been updated and published on the website of the European Medicines Agency (EMA) in March 2021. The documents are the "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" and the "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which refer to pre-authorisation as well as post-authorisation questions. The latest versions of these two sets of questions have each been supplemented by a question regarding the importation of finished medicinal products into the European Union.
Paragraph 18.104.22.168 "Physical importation site" has been added to this section which explains the regulatory requirements for the companies carrying out the physical importation of finished medicinal products and lists the licenses and agreements required for this purpose. It clearly shows that the manufacturing site responsible for the batch certification shall ensure that the physical importation site is licensed and competent to do the physical import. If this is the case and the importer only performs this step of the supply chain, it is not required to register the physical imortation site in the dossier.
Question 7.2.14. "Do I need to record in the dossier a new manufacturing site for physical importation?" has been added to this Q&A document. In addition to the points already explained in the previous section, it mentions that caused by the fact that there is no need to register the physical importation site, also variations for changes in the physical import site are not required.
To check the latest versions of the two "Q&A" documents on pre-authorisation and post-authorisation advices within the centralised procedure please see: