Same law, different lawyers
12 February 2019

Update EMA relocation & regulatory changes

Hein van den Bos, partner

As the European Medicines Agency (EMA) is relocating from London to Amsterdam in view of Brexit, several developments took place during the last few weeks:

EMA priorities during relocation 

To ensure delivery of EMA's services during relocation, EMA has identified its priorities. Late January, EMA published an updated list of priorities from its work program. The main focus of EMA in the short term will be on:

  • the authorisation, maintenance and supervision of medicinal products;
  • ongoing Brexit preparedness and implementation activities;
  • preparing for the implementation of the new veterinary legislation.

Transfer of EU centralized marketing authorisations 

It has been clarified through an amendment of Regulation (EC) No 726/2004 effective as of 28 January 2019 (through Regulation (EU) No 2019/5) that transfers of a marketing authorisation for a centrally approved medicinal product shall be subject to prior approval by the European Commission, following the submission of an application for the transfer to EMA. The procedural rules for transfer of marketing authorisations as laid down in Commission Regulation (EC) No 2141/96 shall remain in force.

Reporting suspected falsification to EMA 

On 8 February 2019, EMA published a new reporting form to be used by pharmaceutical companies when notifying EMA of any suspected falsification of their centrally authorised products. Also, as of 9 February, medicinal products in the EU should carry a unique identifier and an anti-tampering device.

Brexit: updated guidance from EMA and European Commission 

The European Commission and the EMA have published revised Brexit-related guidance for companies on 1 February 2019. The guidance includes (i) Q&A, (ii) practical EMA guidance and (iii) a notice to marketing authorisation holders. New matters addressed in the documents relate (amongst other things) to parallel trade of medicinal products sourced in the UK, GMP inspections and the impact on referral procedures.

Brexit: information from Dutch Ministry of Health

On 6 February 2019, the Dutch Ministry of Health informed parliament on the preparations for a potential no-deal Brexit relating to medicinal products, medical devices, in-vitro diagnostics and human tissues and cells. For medicinal products,the Ministry stressed, again, that if a marketing authorisation holder is currently established in the UK, the marketing authorisation holder should transfer the marketing authorisation, manufacturer's batch release and quality control to a member state of the European Economic Area in order for the product to be used in the Netherlands. For medical devices and IVDs, the Ministry stressed that product dossiers that are registered with a notified body in the UK should be transferred to a notified body in one of the EU27 member states in order for the product to remain available to patients in the EU.

Strengthening Dutch Life Sciences and Health sector with EMA relocation 

On 5 February 2019, the State Secretary for Economic Affairs and Climate wrote to parliament (and presented during a speech held at an EMA relocation event in Amsterdam) that the EMA relocation to Amsterdam presents opportunities to strengthen the Life Sciences and Health sector in the Netherlands. The state secretary expects that the EMA relocation may attract new companies and may prompt already established companies to deploy new activities in the Netherlands. The state secretary noted the importance of a coordinated approach by all stakeholders in order to fully benefit from the opportunities presented by the EMA relocation. To that end, she announced that a National Action Plan for the Life Sciences and Health sector will be published before Summer.

Visiting EMA in Amsterdam? Let us know! Our Amsterdam office is easily accessible from the temporary and (future) permanent EMA premises. We are happy to offer you a meeting place in our Amsterdam office during your visit.