101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 151 Medical: Veterinary: Regulation: Veterinary medicines Purpose The purpose of this notice is to outline the arrangements that would come into force to regulate veterinary medicines in the unlikely event the UK leaves the EU on 29 March 2019 with no agreement in place, with specific reference to:  Marketing Authorisation Holder (MAH) - legal presence requirements  Veterinary ‘Generic’ Marketing Authorisations – reference products  Marketing Authorisation for Parallel Import (MAPI)  Maximum Residue Limits (MRLs) Before March 2019 The UK is currently part of the EU regulatory framework for medicines and is a member of the European Medicines Agency (EMA). The Veterinary Medicines Directorate (VMD) is the UK authorising body for assessing veterinary medicine Marketing Authorisation (MA) applications. Currently, an MAH can be based anywhere in the EU. There are several different legal bases upon which an application for an MA may be submitted. These reflect the type and content of the data submitted in support of the application. Two of these include:  Generic: The MA is based on safety and efficacy aspects of data from an existing approved veterinary medicine authorised within the UK, EU or EEA, which is known as the “reference product”.  MAPI: This is when an EU authorised veterinary medicine is imported and marketed in the UK. The veterinary medicine to be imported (known as the “parent product”) must be “essentially similar” or identical to a UK authorised veterinary medicine. UK MAs can be granted for use in food-producing animals. To ensure consumer safety, and facilitate trade in animal food products, maximum residue levels (MRLs) are set by the European Commission. MRLs are scientifically determined highest levels of pharmacologically active substances that are allowed in food derived from farmed animals (including game) following treatment with veterinary medicines. These foods include lean meat, offal, fat, skin (pigs, poultry and fish only), milk, eggs (poultry only), and honey. After March 2019 if there’s no deal The UK government is committed to negotiating a future relationship with the EU which, for veterinary medicines, would include the UK exploring the terms on which we could remain part of the EMA. However, in a ‘no deal’ scenario, where we are no longer part of the EU regulatory framework for veterinary medicines, the UK would need to carry out functions nationally, which are currently undertaken centrally through the EU. Sharing of common systems, and exchange and recognition of data submitted for regulatory activities, between the UK and EU countries would cease. This would require changes to the Veterinary Medicines Regulations with some implications for veterinary medicine pharmaceutical industry stakeholders. Implications Marketing Authorisation Holder (MAH) legal presence requirements In order to ensure the VMD could retain full control of UK marketed veterinary medicines and could take swift, appropriate legal action to protect public health, the MAH would need to be established within the UK. This would enable the UK to accept Qualified Person (QP) release and Qualified Person Responsible For Pharmacovigilance (QPPV) to be based elsewhere outside of the UK. Actions: Pharmaceutical companies would need to ensure they have an established location within the UK. Further details regarding a timescale for this will be published in due course. Veterinary ‘Generic’ Marketing Authorisations – Reference Products The VMD would not have access to the data packages provided in support of EU approved reference products. Whilst this data would have been assessed by another authorising body, the VMD takes full responsibility for a new generic MA application assessment and would need to have confidence that suitable data are available to support the approval of the new MA. Therefore, new generic applications would need to be restricted to those based on reference products authorised in the UK. However, if