Brexit or no Brexit, deal or no-deal, patients in the UK and the EU will continue to need treatment for all conditions after the 29th of March 2019. In the event of a no-deal Brexit, UK Marketing Authorisation Holders (MAHs) will need to ensure continued authorisation and, hence, supply of medicines in the UK. In an effort to reduce the risk of product shortages in this scenario, the UK government has drafted legislation whereby Centrally Authorisation Product (CAP) Marketing Authorisations (MAs) will automatically convert to UK MAs in a process known as ‘grand-fathering’1. Product Licence (PL) numbers will also be issued to CAPs by the MHRA based on current UK practice2. To facilitate this transition, the Medicine & Healthcare Products Regulatory Agency (MHRA) in the UK has issued guidance detailing the proposed baseline data which will be required to be submitted in the form of an initiating electronic Common Technical Document (eCTD) sequence between 29th March 2019 and 29th March 2020.
Briefly, the data submission package must contain1:
- A cover letter and declaration that the documentation included in the package is approved.
- A single eCTD initiating sequence for the converted EU MA indicating the current authorised and approved position of the product.
- An electronic application form (eAF) for each converted EU MA.
- A complete summary of the historical regulatory activity associated with the CAP including: the type of submission; date of submission to the EMA; summary of submission; regulatory outcome; the date of the outcome and eCTD sequence number of the submission.
- Details regarding the current and previous marketing status of the converted EU MA on the UK market.
- The current EU approved Summary of Product Characteristics (SmPC).
- The current EU approved packaging and leaflets.
The eCTD must be technically valid, and the data submitted must be relevant to the UK market1.
More information regarding the method of submission, which is expected to be via a newly developed portal, and the preparation of an initiating sequence can be found in a document issued by the MHRA entitled Guidance on Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) – proposed requirements for submitting baseline information.
MAHs can opt-out of converting some or all CAPs to UK MAs which would result in the products in question being unlicensed in the UK2. To do so, CAP MAHs should inform the MHRA by the end of January 2019 of any products that they do not wish to convert to UK MAs2.
You can find all of the latest news and documents issued by the MHRA at the link below:
If you wish to discuss how PharmaLex can support your organisation during the transition period when the UK exit the EU, please connect with us at +353 1 846 4742 or firstname.lastname@example.org.
- Medicine & Healthcare Products Regulatory Agency. Guidance on Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) –proposed requirements for submitting baseline information. 26th November 2018.
- Medicine & Healthcare Products Regulatory Agency. Preparations in the event of a No-deal Brexit Preparation: Conversion of Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs). 26th November 2016.