101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 134 Medical: Batch Testing Medicines Purpose This notice updates businesses on the arrangements that will come into force in the unlikely event that the UK leaves the EU on 29 March 2019 with no agreement in place for the regulation of human medicines. This notice only covers arrangements with reference to:  batch testing, by manufacturers, of human medicines  Qualified Person (QP) certification and release, by manufacturers, of human medicines The July 2018 white paper on the future relationship between the UK and the EU set out the government’s offer to explore the terms on which the UK could remain part of the European Medicines Agency (EMA). The Prime Minister has also set out our desire to ensure that products only need to undergo one series of approvals in one country - this is essential in continuing to get new medicines and devices to patients quickly. However, we recognise that companies need certainty on the future requirements for batch testing and QP certification and release after the UK leaves the EU and it’s important that we put in place appropriate contingency plans for other potential outcomes from the EU exit negotiations. Batch testing is the process of confirming every batch of medicine has the correct composition through laboratory tests. QP certification and release is the confirmation that the batch meets the requirements of the Marketing Authorisation (MA) and is suitable for sale and supply or export. The pharmaceutical sector may also wish to consider other relevant notices, including on IT systems, general life sciences, intellectual property, and other manufactured goods. Further guidance on the future regulatory framework for medicines, including biological medicines, IT systems requirements, manufacturing and import licensing will be published later this year. Before 29 March 2019 Manufacturers can batch test medicines anywhere in the EU, EEA or other third countries with whom the EU has a ‘Mutual Recognition Agreement’ (MRA) under Article 51(2) of Directive 2001/83/EC (“the Directive”). For human medicines manufactured in the UK, a UK-based Qualified Person must certify the batch testing and ensure compliance with the MA and Good Manufacturing Practice (GMP) guidelines. These medicines can then be sold or supplied anywhere in the EU or EEA, including the UK, without further certification. For human medicines manufactured in the EU/EEA, the batch testing and certification or release by an EU or EEA based QP allows a batch of human medicines to be sold in any other EU or EEA country (subject to the requirements of the country), including the UK, without the need for any further certification. For human medicines manufactured in a third country outside the EU or EEA and imported into the UK through the EU or EEA, batch testing is required within the UK, EU or EEA, unless the medicine has been manufactured in a third country with which the EU has an MRA. However, a human medicine manufactured in a third country requires a QP based in the UK, EU or EEA to certify that it meets all the required standards and specifications of the Marketing Authorisation, before it can be sold or supplied in the EU or EEA (including the UK). After 29 March 2019 if there’s no deal In the unlikely event of no deal, the UK would no longer be part of the EMA. In order to ensure continuity of supply in medicines however, the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA. On exit day, this list would include EU countries, other EEA countries and those third countries with which the EU has an MRA. The UK will also continue to accept batch testing of Investigational Medicinal Products (IMPs) – substances being used in medical trials - manufactured in EU and EEA states. There will be no change to the present arrangements for batch testing of IMPs manufactured in third countries. For human medicines manufactured in the UK, we will continue to require a UK-based QP to certify the batch testing and to ensure compliance with the Marketing Authorisation and GMP guidelines, before these medicines can be sold or supplied in the UK. For human medicines manufactured in a third country and directly imported into the UK, we will continue to require a UK-based QP to certify the batch testing, as well as to ensure compliance with the MA and with GMP guidelines, before they can be sold or supplied in the UK. Where human medicines are manufactured in a third country but are imported into the UK from a country on a separate list maintained by MHRA (on exit day, this list will contain EU and EEA countries), we will continue to recognise certification, release and assurance of compliance with the MA and with GMP guidelines, if conducted by a QP based in the listed country, without the need for any further certification.