101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 140 Pharmacovigilance Currently pharmacovigilance, which is the monitoring of the safety of medicines on the market, is co-ordinated at EU level. If there’s ‘no deal’, the MHRA will have primary responsibility for the conduct and oversight of all pharmacovigilance activities in relation to UK MAs, certificates of registration and traditional herbal registrations. The details of our approach will be subject to consultation. Sharing of common systems, and formal exchange and recognition of data submitted for regulatory activities between the UK and EU countries would cease. The MHRA already holds its own database of Individual Case Safety Reports (ICSRs), so will not require historical information from MAHs. In future, for medicines sold in the UK, MAHs will be required to submit pharmacovigilance data (UK and non-UK ICSRs and PSURs (Periodic Safety Update Report)) directly to the MHRA. An Individual Case Safety Report (ICSR) is an adverse event report for an individual patient and is a source of data in pharmacovigilance. A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined points in time post- authorisation. Online sellers The EU common logo for online sellers currently allows sale of medicines throughout EU countries and can be issued by the MHRA and other EU competent authorities. In order to sell into the EU, EU-based online sellers have to register, comply with relevant requirements and display an EU common logo linked to the competent authority in which they are based. As they would be outside of the EU, UK-based online sellers would no longer be required to do this. For the UK market, we propose to explore requiring the use of new ‘UK logo’ for UK-based online sellers from 2021. Good X Practice (GxP) Guidelines GxP refers to guidelines established to ensure that businesses working in regulated industries, such as pharmaceuticals, make products that are safe, fit for use, and which have met strict quality standards throughout the entire process of production. The “x” stands for the particular field, for example manufacturing (GMP) or distribution (GDP) and so on. In the event of a no deal scenario the UK proposes to continue using, until further notice, the EU Good Manufacturing Practice and Good Distribution Practice guidelines, as issued under Article 47 and 84 of the 2001 Directive. Parallel Distribution and Parallel Imports Parallel imports are goods produced genuinely under protection of a trademark, patent, or copyright, placed into circulation in one market, and then imported into a second market without the authorisation of the local owner of the intellectual property right. EU exit does not mean that parallel imports of medicines will cease. Under the TRIPS agreement - the Agreement on Trade-Related Aspects of Intellectual Property Rights, an international legal agreement which governs international rules around intellectual property and trade - countries may choose their own exhaustion regime (for products that have been sold by an intellectual property owner) which means they can determine whether or not to allow parallel imports. If there’s ‘no deal’, the UK will unilaterally align to the EU/EEA exhaustion regime from Exit day to provide continuity in the immediate term for businesses and consumers and ensure that parallel imports of goods, such as pharmaceuticals, can continue from the EU/EEA. We’re currently considering all options for how the exhaustion regime should operate after this temporary fix. Any substantial changes to the exhaustion regime will occur only after a full research programme and consultation. Our intention is to convert all currently approved Parallel Distribution Authorisations of CAPs into parallel import licences. In order to grant parallel import licences after exit day the MHRA would also require full product information from the source country competent authority in order to verify the safety of the medicine and that the product is essentially the same as the reference product on the UK market. Devices Medical devices on the UK market For a time-limited period, we would continue to recognise the CE Mark on medical devices, which demonstrates their conformity with EU regulatory requirements. During this period, devices would be accepted on the UK market if they meet all EU requirements, which for all but the lowest-risk devices would include certification by EU Notified Bodies. Further detail on the future process after this temporary situation of bringing a medical device onto the UK market will be subject to consultation in due course. Notified Bodies