Serialisation – New EU Aide Memoire for GDP
With just weeks remaining before the planned Brexit date of 29 Mar 2019 will soon be upon us, and the increasing likelihood of a no-deal situation, are you ready? Industry must position itself for a no-deal scenario but what exactly does this mean?
The Medicines and Healthcare product’s Regulatory Authority (MHRA) in the UK issued a press release on 03 Jan 2019 and have advised that key arrangements for the continued supply of medicines, medical devices and clinical trials in the UK must include:
Medicines:
- automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process known as ‘grandfathering’
- targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion
- a full accelerated assessment for new active substances
- free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs)
- a period until the end of 2021 to amend packaging and leaflets for a product already on the market
- allowing the parallel import of medicinal products that hold a marketing authorisation from an EU or EEA country
- continuing to recognise prescriptions issued in EU or EEA countries.
Medical Devices:
- for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market
- the expansion of the MHRA’s registration system to all classes of medical device.
Clinical Trials:
- continuing to recognise existing approvals so there will be no need to re-apply
- requiring the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list which would initially include EU or EEA countries
- aligning, where possible, with the EU Clinical Trials Regulation when it applies
Further detailed guidance was also published and is available in the following MHRA document:
Where the Marketing Authorisation Holder (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 the exit date. This individual must be accessible to the licensing authority in respect of any matter relating to the Marketing Authorisation (MA). This requirement will no longer apply once a UK MAH is established.
UK based MAH’s who wish to continue to supply to the EU are bound by regulatory legislation to seek alternative MAH locations within the EU. As an MAH, it is very important to understand that the MAH retains responsibility for all MAH activities even if they have been delegated via a contractual agreement.
We, at PharmaLex, can support your organisation in many ways including the provision of regulatory support for MAH’s, performance of Brexit readiness assessments or provision of a collaborative responses to any technical queries that you may have in relation to Brexit. Please connect with us to discuss +353 1 846 4742 or email us at contactirl@pharmalex.com.
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