The UK Government has published a series of technical notices that provide guidance to the industry. The “no deal” scenario is one where the UK leaves the EU and becomes a third country at 11pm GMT on 29th March 2019 without a Withdrawal Agreement being in place between the UK and the EU. The guidance documents do stress that the UK government is working to agree a trade deal with the EU and the position set out in the notices are only applicable in the “unlikely scenario that they need to be relied upon”. However, the EMA has published on its website that it is “working on the scenario that the UK will become a third country” as of the above exit date.
A total of 25 notices were published as part of a series in August and September 2018 to allow businesses and citizens prepare. Several guidance documents relevant to the pharmaceutical industry have been published and require careful consideration from the industry. The series of notices include the documents listed below that are particularly relevant to the pharmaceutical sector:
- Batch testing medicines if there’s no Brexit deal
- Ensuring blood and blood products are safe if there’s no Brexit deal
- How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
- Quality and safety of organs, tissues and cells if there’s no Brexit deal
- Submitting regulatory information on medical products if there’s no Brexit deal
- Trading in drug precursors if there’s no Brexit deal
So what are the implications of such a scenario? Some of the key points in the guidance documents include:
- All centrally authorised medicinal products will automatically be converted into national UK marketing authorisations (MA) on 29th Mar 2019.
- Applications (i.e. centralised, decentralised and mutual recognition procedure) in progress on exit day will not be valid in the UK and will continue to be assessed by the MHRA as National Procedures.
- Future MA submissions will have to be submitted into both MHRA and EMA. The new process will be streamlined with the intention to issue the UK MA and the EU MA concurrently.
- New generic applications would need to be based on reference products that have been authorised in the UK.
- A UK based MA holder will need to be established in the UK by the end of 2020
- The Qualified Person for Pharmacovigilance (QPPV) should be established in the UK by the end of 2020. However, from exit day, the MHRA should have access to the relevant safety data from the EU QPPV.
- With respect to medical devices, the UK will, for a limited period, continue to recognise the CE mark so devices will be accepted on the UK market if they meet EU requirements. The MHRA, however, will no longer be able to oversee Notified Bodies.
- UK clinical trial applications will continue to be authorised by the MHRA. However, Clinical Trial Regulation 536/2014 planned for implementation in 2019 will not be in effect in the EU when the UK exits the EU.
- The UK will continue to accept batch testing of human medicines and investigational medicinal products carried out in countries on a list created by the MHRA. The UK will also require a UK, EU or EEA-based QP to certify batch release and to assure compliance with the marketing authorisation.
- The UK would no longer be part of the EMA regulatory network shared processes which would result in the requirement for regulatory information relating to human medicines and devices to be submitted directly to the MHRA. In addition, the UK would no longer be part of the EU system for sharing pharmacovigilance information which would mean that the MHRA will take on the primary responsibility to oversee pharmacovigilance activities relating to UK MAs and UK MAHs would have to submit PV data directly to the MHRA.
- Public consultation is proposed on other areas including Orphan medicinal products, paediatric medicines and medical devices
- The current EU Blood Directives would no longer apply to the UK and arrangements for sharing blood, blood components and information with EU partners would be based on the UK’s status as a third country.
The UK government’s guidance documents are very welcomed by the industry as they provide some clarity as to the no deal scenario. Make sure you give them the careful consideration they require!
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