EMA/Commission guidance re centralised procedure and Brexit

Good morning from London where it is business as usual.

Given uncertainty surrounding the outcome the forthcoming Brexit negotiations, this GuestKat was interested to learn of guidance issued last week by the European Commission and the European Medicines Agency.  This took the form of a set of Q&As drafted jointly by both bodies "related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure". 

Easier said than done?

The Commission and EMA intend to issue a series of Q&As to provide guidance to marketing authorisation holders.  This first set of Q&As concerns information related to establishment requirements within the EU/EEA.  The publication's introduction notes that "preparing for the consequences of the UK's withdrawal from the Union is not just a matter for European and national administrations, but also for private parties". 

The EMA has previously stated that "although negotiations on the terms of the UK's departure have not yet officially commenced and one cannot prejudge their outcome, work will now start on the basis of the scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory system as of 30 March 2019" (see press release here).  The EMA is therefore proceeding on the basis that there will be no deal concerning the matters in issue, and that the UK will become a 'third country' in Spring 2019.

What do the 9 Q&As cover/recommend? Some extracts are set out below to give interested readers a flavour of the guidance:

"1. What if I am a marketing authorisation holder established in the UK?

According to Article 2 of Regulation (EC) No 726/2004 the marketing authorisation holder must be established in the Union. Through the EEA Agreement this is extended to include also Norway, Iceland and Liechtenstein.

For centrally authorised medicinal products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation to a holder established in the Union (EEA) (see Commission Regulation (EC) 2141/96 and EMA Q&A on transfer). This means that the addressee of the marketing authorisation decision changes to the new addressee." [Notwithstanding the brevity of the statement, the IPKitten suspects that the implications of a restructuring whereby centrally authorised MAs are transferred out of a UK company to a company of an EU/EEA member state may be considerable.]   

The QPPV Kat - on the move 

"4. What if my Qualified Person for Pharmacovigilance (QPPV) resides and carries out his/her tasks in the UK?

According to Article 8 of Directive 2001/83/EC and Article 74 of Directive 2001/82/EC, the qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in the Member State of the Union (EEA). The QPPV will therefore need to change his/her place of residence and carry out his/her tasks in the Union (EEA) or a new QPPV residing and carrying out his/her tasks in the Union (EEA) will need to be appointed."

[So either the QPPV moves to an EU/EEA member state, or that role is transferred to someone else who is resident/carrying on tasks in the EU/EEA] 

The EMA has set up a section on its website dedicated to information concerning the UK's departure from the EU.  The IPKat will keep you posted on developments of interest.