Brexit update Oct 2018 - EMA cuts back non-core business, Denmark clarifies labeling requirements and UK prepares for "no-deal"

With less than six months to go until the UK leaves the EU, the European Medicines Agency (EMA), the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) and the UK Veterinary Medicines Directorate (VMD) are increasing their preparatory activities for post-Brexit regulation of veterinary medicines. Meanwhile, the rest of Europe is also making preparations and the Danish Medicines Agency (DMA) has recently issued a clarification for industry.

Business Continuity Planning at the EMA

As of October 2018, the EMA has now entered the third phase of its business continuity plan in preparation for Brexit (Link). In this third phase, the following are examples of activities which will be scaled back or temporarily suspended:

• International activities
• Guideline development
• Working Group on Quality Review of Documents (QRD)
• Stakeholder interactions

These cut backs are principally due to staff losses relating to Brexit and increased resources required for the physical move to Amsterdam, progress of which can be tracked here (Link).

The latest EMA press release for Brexit preparedness provides a useful summary of the current state of play (Link). For more detailed information, the presentations from the recent “Industry stakeholder meeting on Brexit and operation of centralised procedure for human and veterinary medicines” are now available online (Link).

CMDv Brexit Q & A for VMPs

The CMDv has updated its document "Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for veterinary use", with a new question relating to the status of outcomes from inspections (GMP, GCP and pharmacovigilance) carried out by UK authorities. The full Q & A docuemnt can be found here (Link).

UK "No-deal" Brexit preparations for animal health product regulation

The UK VMD has prepared a “Stakeholder Engagement” PDF, providing guidance for industry if there is no Brexit deal, which gives a simple overview of all areas of impact for UK authorised products (Link). More detailed information can be found in the industry guidance for a Brexit “no deal", which is split into three technical notices (Link):

Registration of VMPs (Link)

• Batch testing of VMPs
• QP batch certification & release of VMPs
• Wholesale Dealer’s Authorisations
• Manufacturing Authorisation requirements for imported VMPs from the EU
• Centralised VMP authorisations

Regulation of VMPs (Link)

• MAH - legal presence requirements
• Veterinary ‘Generic’ MAs – reference products
• MAs for Parallel Import (MAPI)
• Maximum Residue Limits

Access to IT systems (Link)

• Common European Submission Portal (CESP)
• EudraVigilance veterinary (Gateway / Webtrader)
• EudraLink

Other EU member state Brexit communications

The Danish Medicines Agency has announced that there will be a two-year implementation period during which medicines with packaging indicating a UK marketing authorisation holder (MAH) will be permitted on the market (Link – Danish only). There will be no requirement to withdraw “UK labelled” products during this implementation period.