{"id":512,"date":"2026-08-31T18:13:05","date_gmt":"2026-08-31T16:13:05","guid":{"rendered":"https:\/\/www.pqra.gr\/transferring-a-marketing-authorisation-a-30-day-procedure-with-a-six-month-tail\/"},"modified":"2026-08-31T18:13:22","modified_gmt":"2026-08-31T16:13:22","slug":"transferring-a-marketing-authorisation-a-30-day-procedure-with-a-six-month-tail","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/transferring-a-marketing-authorisation-a-30-day-procedure-with-a-six-month-tail\/","title":{"rendered":"Transferring a Marketing Authorisation: A 30-Day Procedure with a Six-Month Tail"},"content":{"rendered":"

A marketing authorisation transfer looks like paperwork and behaves like a project. The regulatory step itself is fast \u2014 the European Medicines Agency must issue an opinion within 30 days \u2014 but the operational handover behind it runs for months, and most of the things that go wrong have nothing to do with the transfer application at all.<\/strong><\/p>\n\n

The centralised transfer is a 30-day procedure<\/h2>\n\n

Transfers of centrally authorised products are governed by Commission Regulation (EC) No 2141\/96. A “transfer” means changing the addressee of the marketing authorisation decision \u2014 the new holder is a different legal person from the previous one. Under Article 4, the Agency must deliver its opinion within 30 days of receiving the application, and in practice EMA carries out a completeness check within seven days and aims to finalise a complete application by Day 10. If the dossier is incomplete, the applicant has ten calendar days to respond and the procedure targets Day 20.<\/p>\n\n

The opinion can only be unfavourable on two grounds: the supporting documents are incomplete, or the transferee is not established within the Union. Once the Commission amends its decision, the transfer is authorised from the date that amendment is notified.<\/p>\n\n

Day A, Day B, Day C \u2014 where the real risk sits<\/h2>\n\n

EMA works to three milestones. Day A is receipt of a valid application. Day B is notification of the Commission Decision: from that point the transferee is the marketing authorisation holder and becomes EMA’s contact for every subsequent regulatory activity. Day C is the implementation date, agreed between the parties.<\/p>\n\n

The gap between Day B and Day C is the transitional period, and it must not exceed six months. Batch release is the clause that catches people out:<\/p>\n\n