101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 139  If the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion by exit day, MHRA will make its decision taking into account the CHMP opinion  If not yet at the opinion phase, the MHRA will continue to assess the application as a national procedure. MHRA will take into account any CHMP assessment that had already taken place. For MR or DC procedures in progress at time of EU Exit it’s proposed that a transitional provision will be made for MRP and DCP procedures in progress immediately before Exit day. These procedures currently already result in a national MA. We’ll complete the assessment (the transitional process for this will depend on how far the procedure has got immediately before Exit day) but if successful, they will be approved as a national (UK) MA. Data and market exclusivity for Marketing Authorisations We’re not proposing any changes to the data and market exclusivity periods for UK MAs. After the UK’s exit from the EU, the start of data or market exclusivity will be the date of authorisation in the EU or UK, whichever is earlier. ‘Generic’ MAs – reference products The MHRA will not have access to the data provided in support of EU approved products. Therefore, new generic applications would need to be based on reference products that have been authorised in the UK. Existing MAs for generic products which are based on a reference product authorised in the EU would remain valid. Legal presence requirements At present, the MHRA requires a named individual who can be contacted in the event of a safety issue, and has the ability to require independent re-testing of medicines and also the ability to withdraw a product from the market. This will continue if there’s no deal. The requirement for this would include:  a MAH should be established in the UK by the end of 2020. Until then, the MHRA will require a contact in the UK. A Change of Ownership will need to be submitted to MHRA to change from an EU MAH to a UK MAH for UK MAs  the Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one, although those without a current UK presence will have until the end of 2020 at the latest to do so, but would nevertheless be required to make arrangements for providing the MHRA with access to the relevant safety data related to UK Marketing Authorisations (MAs) at any time. Companies may choose to have the EU QPPV take on responsibility for UK MAs until the UK QPPV can be established. A variation should be submitted to the MHRA to change QPPV. Exact details of this will be consulted upon  a Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from outside a country on a designated country list (whitelist) must reside and operate in the UK. A QP for products manufactured in a country on a whitelist or manufactured in a third country and imported into the UK from a country on a whitelist can reside in a country on the whitelist. Paediatric medicines Human medicines for children are known as paediatric medicines. In a ‘no deal’, there will be a UK system for regulation of paediatric medicines in which the UK will ensure incentives remain to encourage such medicines onto the UK market. We will make provisions for a UK Paediatric Investigation Plan (PIP), including the deferral and/or waiver of the requirement for studies where appropriate as currently provided for in EU legislation. Details of this will be subject to consultation. Orphan medicines Medicines that have been developed to treat rare diseases are known as orphan medicines. We will be consulting on the proposed UK approach to the regulation of orphan medicines post-exit, including on incentives to encourage such medicines onto the UK market. Packaging and leaflets The MHRA would continue to accept proposals for packaging and leaflets in the English language that include information from other jurisdictions (such as Ireland), as long as information complies with UK requirements. The MHRA would be pragmatic in changing UK requirements and would provide time for companies to comply with any changed requirements, including updates to packaging and leaflets. Any changes will be subject to consultation. Advanced Therapy Medicinal Products (ATMPs) An ATMP is a medicinal product which is either: a gene therapy medicinal product, a somatic cell therapy medicinal product or a tissue engineered product. MA applications for ATMPs to be marketed in the UK, whether for an initial, variation or in progress application, or a conversion from a CAP, would be treated as set out above.