101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 152 a specific EU product, not authorised in the UK, was required for the treatment of an individual/group of animals, this could be obtained from a veterinary surgeon through the current Special Import Scheme. Existing generic-based UK MAs, which cite an EU authorised reference product, would still remain authorised after the UK leaves the EU. Any changes to the MA would require the original data to be submitted to the UK for approval. Actions: For new generic applications, pharmaceutical companies would need to ensure these are based on UK reference products. For currently authorised generic applications which cite an EU reference product, if future changes were to be made these may need to be supported by proprietary data, as appropriate. MAPI (Marketing Authorisation for Parallel Import) MAPI applications require assessment to confirm the proposed EU authorised parent product is ‘essentially similar’ or identical to a UK MA. In a ‘no deal’ scenario, the UK would continue to accept veterinary MAPI applications, but original data from the parent product would not be available from the authorising EU country. The responsibility for obtaining necessary parent product data would pass to the MAPI applicant who would need to contact the regulatory authority for the parent product. Actions: Pharmaceutical companies wishing to submit MAPI applications would need to ensure they would be able to obtain the parent product data from the regulatory authority for the parent product. Maximum Residue Limits (MRLs) Existing EU MRLs would become UK law via the EU Withdrawal Act. This would ensure the UK can continue to trade animal food products with the EU and the majority of third countries that recognise the EU process. After this, the UK would need to set new MRLs and modify existing MRLs on a UK domestic basis. In order to assess MRL applications, the VMDwould need to have access to supporting data. To maximise flexibility, the Secretary of State for Defra would have the power to set MRLs based on data from a range of sources, including other MRL setting bodies. UK exporters of products of animal origin to the EU would need to ensure they comply with EU MRLs, including those which may diverge from UK MRLs. Marketing veterinary medicines in the EU The EMA has published guidance on its website as to the approach EU/EEA/EFTA countries will take on human and veterinary medicines certified by a UK-based Qualified Person. Please refer to th e EMAwebsite f or this advice if relevant to your organisation. Actions: New MRL applications need to be submitted to the UK with the full supporting data, as appropriate. UK exporters of products of animal origin to the EU would need to ensure they comply with EU MRLs, including those which may diverge from UK MRLs.