Implementation of an efficient QRM program
BREXIT Implementation Period for the Life Sciences
On 6th August 2018 the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) published guidance relating to the Brexit “implementation period” and what it means for the life sciences sector. The proposed Brexit implementation period will run from 30th March 2019 through to 31st December 2020.
This guidance document explains what the implementation period actually means for the life sciences sector, assuming that the draft withdrawal agreement is ratified by the UK and the EU. If the agreement is not ratified and the UK leave the EU with no deal on 29th March 2019, then there will be no implementation phase and this guidance document does not apply.
The aim of the implementation period is to set the life sciences sector up for business as usual, with market access remaining as is during the period. This is extremely important to ensure continuity of patient supply is maintained.
The guidance outlined within this document can be summarised as follows:
- Firms in the life sciences sector can continue batch release testing and qualified person certification in the UK, with this being recognised by the EU and vice versa.
- Marketing authorisation holders and qualified persons can continue to be based in the UK and access EU markets.
- Pharmacovigilance activities, including the qualified person for pharmacovigilance, can continue to be based in the UK and access EU markets.
- UK Manufacturing and Distribution licences, as well as regulatory inspections, will continue to be recognised by the EU and vice versa.
- Firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures. However, the UK will no longer be able to act as the lead authority (Reference Member State) in these procedures for approval of marketing autborisations.
- For medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.
- Labelling rules will remain the same until the end of the implementation period, allowing multi-country packs for medicinal products to be valid for the EU, including the UK.
- The UK will continue to be treated as a Member Stated for the purposes of international agreements, including Mutual Recognition Agreements.
The target date for finalisation of the withdrawal agreement is October 2018 and this will provide the necessary clarification on whether the implementation period will apply or not.
At PharmaLex, we have a team of consultants who are currently supporting several companies with their Brexit planning activities. We have considerable expertise in the different requirements and the respective timelines that are required to be met before the 30 March 2019 deadline. Contingency planning is unique to each company and PharmaLex would be more than happy to facilitate a call with your company to help with your Brexit readiness and contingency planning.
If you would like further information or wish to discuss how we can tailor our services to meet your specific need’s please connect with us to discuss +353 1 846 4742 or contactirl@pharmalex.com
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