Building bridges for the animal health industry
The prospective withdrawal of the UK from the EU has brought with it uncertainty for all industry sectors and the animal health industry has many particular concerns. As discussed at the recent EMA event “Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure” there is essentially a continued drive to “hope for the best, but plan for the worst”. In this context, the worst is a hard Brexit, where the UK becomes a third country and has a regulatory system separate from the EU from 31/10/2019 (extended from the previously stated deadline of 29/03/2019).
Regulatory affairs support for the UK and the EU
With headquarters in Bristol, UK and our new office in Mannheim, Germany, Cyton can continue to offer all of our services in regulatory affairs and product development, in both regions, regardless of the final outcome of the Brexit negotiations.
Based on recommendations from the EMA and other European regulators (refer to the separate Brexit news page on our website), there are some activities which industry can already commence in preparation for Brexit. In this context, Cyton can offer support with the activities discussed below.
Marketing authorisation holder transfers
It has been confirmed in communications from the EMA and other EU Competent Authorities, that following the UK’s exit from the EU, UK-based companies can no longer hold Marketing Authorisations for Veterinary Medicinal Products marketed in EU Member States. These include nationally authorised products but also so-called ‘Community authorisations’ licensed via the Centralised, Decentralised or Mutual Recognition procedures. Cyton can assist with preparation, submission and oversight of MA transfer applications.
Reference Member State (RMS) changes
The Veterinary Medicines Directorate (the VMD – the UK agency) will no longer be able to act as RMS for European Marketing Authorisation Application procedures, and for VMPs already marketed in the EU where the UK acted as RMS, this responsibility will need to be transferred to the authority of another Member State.
Product literature updates
Changes to product literature may be necessary due to changes in ownership, new distribution arrangements, or changed national requirements following divergence of harmonised labelling.
Batch control and release site change variations
It has not yet been clarified how the exact requirements for Qualified Persons will change. However, as is the case for holding EU Marketing Authorisations, batch release for the EU market will no longer be possible from a UK address and this function will need to be transferred. Cyton has extensive experience in managing such variations.
EU and UK pharmacovigilance support, including veterinary QPPV
Our new office in Mannheim, Germany will allow us to ‘cover all bases’ in pharmacovigilance support, with experienced staff, suitably qualified to act as the QPPV, residing both in the UK and in mainland Europe.
Transfer of MUMS classification status
Since the incentives available for Minor Use, Minor Species products are a European Union initiative, it will be necessary for UK-based license holders to transfer MUMS products to European companies in order to continue to avail of the incentives.
All of the activities discussed above are carried out as part of Cyton's routine work in life cycle management and pharmacovigilance, so you can be sure of a smooth and efficient service.
Brexit News - keep track of the latest developments
To maintain your awareness of any Brexit related developments which have implications for the animal health industry, please visit our dedicated news feed:
Useful external Links
European Commission Brexit preparedness notices (Sante) - includes a general explanatory notice and a Q & A document:
European Medicines Agency (EMA) Brexit landing page
UK Veterinary Medicines Directorate (VMD) EU Exit information hub