- marketing authorisation (MA) applications
- periodic safety update reports (PSURs)
- paediatric investigation plans (PIPs)
- clinical trial applications
- qualified person for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) notifications
- individual case safety reports (ICSRs) and subsequent transmission of anonymised single patient reports (ASPRs)
- device registration
- e-cigarette notifications
Converting CAP’s to UK MAs“Most medicines on the UK market already have a UK Marketing Authorisation (MA), and this will be unaffected by exit from the EU. However, most new medicines come to market via a licencing route overseen by the EMA. These are collectively known as Centrally Authorised Products (CAPs). To ensure such medicines will continue to be authorised for use in the UK, all CAP MAs will automatically be converted into UK MAs on 29 March 2019. MHRA will write to all CAP Marketing Authorisation Holders (MAHs) prior to 29 March 2019 to inform them of the conversion process (known as “grandfathering”) and to provide them with the opportunity to opt out of receiving a UK MA”.
Initial MA ApplicationsMA applications would need to be submitted to the MHRA and will go through a national assessment.
Mutual Recognition Procedures and Decentralised ProceduresExisting medicines that received a MA for the UK via the MR or DC routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA.
In-progress licensing procedures at time of exitThe document issued today by DExEU states “If there’s ‘no deal’, the outcome of EU procedures (including mutual recognition, decentralised and centralised procedures) that have not reached the decision phase at the time that the UK exits the EU, will not be valid in the UK. However, the MHRA will take EU decisions into account where possible. For centralised procedures in progress at time of EU exit:
- The application, as submitted to the EMA, will need to be submitted to the MHRA
- 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 CHMPopinion
- 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”. ‘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.
Legal presence requirementsThis is an issue that has arisen on numerous occasions in discussions with our clients. Again, quoting today’s document: “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”.