As it stands the UK remains on course to leave the EU on 29 March 2019. That is of course unless a number of other scenarios don’t play out, including a delay. At Panacea, we’ve kept track of the evolving BREXIT landscape. For the purposes of this post, we are setting out some of the actions and mitigating steps Marketing Authorisation Holders (MAHs) should consider in the event of a No Deal scenario based on whether they are based in either the EU or UK:
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MAH with UK MAs
MAH with EU MAs
MAH with UK MAs
- QPPV should be established in the UK however, a temporary exemption will allow companies until the end of 2020; EU QPPV can assume responsibility for UK MAs until a QPPV who resides and operates in the UK can be established
- Where the MAH is not established in the UK on exit day, companies will be expected to put in place a UK-based contact person within four weeks of Exit. This requirement will no longer apply once a UK MAH is established.
- MHRA Contingency legislation
- MHRA Guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
- MHRA How to make regulatory medicines submissions to the MHRA if the UK
leaves the EU with no deal
MAH with EU MAs
- QPPV/ Deputy (back-up):
- According to Directive 2001/83/EC, the QPPV/ back-up must reside and carry out tasks in a Member State of the Union (EEA).
- The QPPV/ back-up will need to change place of residence if they currently reside in the UK, or new QPPV residing and carrying out tasks in the Union (EEA) needs to be appointed.
- QPPV changes, including contact details (telephone, fax, address, email) may be updated through the Article 57 database only (no variation).
- However, if national MA has to be transferred to a new legal entity, a new summary of the PV system has to be submitted as a type IAIN variation.
- According to Directive 2001/83/EC the MAH must be established in the Union (EEA).
- For national authorised medicinal products the MAH will need to transfer its MA to a holder established in the Union (EEA). The transfer of the MA must be fully completed and implemented before 30 March 2019.
- Same rules follow for MAAs – applicants established in the UK will need to change to a non-UK applicant established in the Union (EEA) before 30 March 2019.
- RMS must be a member state of the Union (EEA). After 29 March 2019, UK will not be able to act as RMS (with or without withdrawal agreement – as in withdrawal agreement UK won’t partake in decision-making of EU institutions and bodies). For existing MAs, MAHs strongly advised to change RMS before 30/03/19. After 29 March 2019 the MAH will not be able to make any regulatory submission until new RMS other than UK is appointed. A change of RMS cannot take place during a pending procedure. Ongoing variations and renewals: All ongoing variations and renewals in process with UK as RMS that are not finalised prior to 29th March will be stopped and need to be resubmitted.
- EMA’s plans for Brexit.
- Brexit-related guidance for companies.
- CMDh Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to national authorised medicinal products for human use
See below for Panacea’s social medial updates regarding #BREXIT