Variations, Renewals, MA transfer

During the lifecycle of a medicinal product, the Marketing Authorisation has to be maintained according to up-to-date regulatory requirements.  It will also need to be changed if new information or data becomes available on the product.  All changes have to be introduced through controlled regulatory procedures and are subject to assessment by the Competent Authorities.

Following an initial Marketing Authorisation (MA), various post-authorisation procedures are in place to ensure the lifecycle continuity of the authorised product. The three key procedures are:

• Variations
• Renewals
• Marketing Authorisation transfers
   

Variations

Variations to an MA encompass all changes made to an MA after its initial registration. These changes may concern administrative changes, quality changes, safety/efficacy changes or pharmacovigilance changes. According to the European Commission Regulation (EC) No 1234/2008 of 24 November 2008, and the Guideline on the classification of variations (2013/C 223/01), the classification of variations (type IAIN, type IA, type IB and type II variations, Extension of an MA, or Article 61(3) notification) determines the timetable of the variation procedure and the level of assessment required.

Renewals

In accordance with Article 14(1-3) of Regulation (EC) No 726/2004, an initial MA is valid for five years and then has to be renewed, except for Conditional MAs granted under Article 14(7), which have to be renewed annually. The renewal application has specific documentation and submission requirements. The application undergoes a formal assessment procedure during which there may be a request for information before a renewal is granted.
For Centralised Procedures and national MAs (issued by EU Member States), once renewed, the MA shall be valid for an unlimited period, unless the competent authority decides to proceed with one additional five year renewal for justified reasons.

Marketing Authorisation Transfers

An MA Transfer is the procedure by which the MA is transferred to a new MAH (this is a different legal entity). For licences granted via the Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP) such a transfer of ownership is granted nationally and the regulatory requirements and timelines are based on the national legislation in the Member States (MS). For licences granted via the Centralised Procedure (CP), the transfer is granted by the EMA.

Consequential changes often occur due to an MA Transfer, such as name change of the medicinal product, or the submission of the summary of the pharmacovigilance system of the new MAH. If these changes fall under the variation regulations, they must be implemented according to the relevant variation procedures after the MA transfer is complete.