Brexit: New Notice to Stakeholders

In the current Corona crisis, some people tend to forget that we are facing another challenge this year: Brexit. The leave of the UK will also affect pharmaceutical industry. Both EU Commission an EMA have now published a new Notice to Stakeholders "Withdrawal of the United Kingdom and EU Rules for medicinal Products for human Use and veterinary medicinal Products". This document with the revision number REV3 - replaces the notice REV2 dated 1 February 2019 AND the Q&A document
(REV4) dated 1 February 2019.

It is pointed out in the document that it is not certain whether an agreement on a new partnership will be concluded by end of the transition period. And even if such an agreement will enter into force, relationships, also in terms of market access conditions, will be very different from what we have now.

The document summarises the most important aspects in three parts:

• Part A: The legal situation as of the end of the transition period
• Part B: Explanation of certain relevant separation provisions of the Withdrawal Agreement
• Part C: Rules applicable to Northern Ireland as of the end of the transition period

Part A describes that at the end of the transition period, the EU rules in the field of medicinal products, in particular Regulation (EC) No 726/2004,6 Directive 2001/83/EC,7 and Directive 2001/82/EC,8 will no longer apply to the UK. This should be of particular interest for the pharmaceutical industry as Part A gives a compact but comprehensive overview of the consequences, in particular on:

• Issues related to marketing authorisation, marketing authorisation procedures
• Manufacturing and importation of finished products and active pharmaceutical ingredients
• Parallel trade
• Pharmacovigilance, incl. Qualified Person for Pharmacovigilance and post-marketing authorisation procedures
• Orphan medicines, traditional herbal medicinal products (medicinal products for human use)
• Product information and labelling
• Safety Features (medicinal products for human use)
• Inspection results

Here are some highlights (all quoted).

As of the end of the transition period, medicinal products shipped from the United Kingdom to the EU will be imported medicinal products, and the requirements for importers apply: In case of a new authorised importer established in the EU, the corresponding variation has to be submitted:

As of the end of the transition period, UK authorities will no longer undertake the role of a supervisory authority. The new EU supervisory authority responsible for supervision of manufacturing sites located in the United Kingdom and third country sites previously inspected by the United Kingdom will decide, using a risk-based approach, when an inspection of the site(s) concerned will be required, in order to confirm or re-confirm GMP compliance.

The Qualified Person of the [EU] manufacturing and importation authorisation holder is responsible to certify that each batch of medicinal product intended to be placed on the EU market was manufactured in accordance with EU GMP requirements and the marketing authorisation.

Each batch imported into the EU has to undergo upon importation a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation. Where a batch release site is transferred to the EU, the corresponding variation has to be submitted. A medicinal product/active pharmaceutical ingredient shipped from Northern Ireland to the EU is not an imported medicinal product; a medicinal product/active pharmaceutical ingredient shipped from Great Britain to Northern Ireland is an imported medicinal product.

As of the end of the transition period, active substances manufactured in the United Kingdom and imported into the EU are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing that exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU.

GMP certificates issued by the UK competent authority before the end of the transition period are to be considered as information on GMP compliance from the third country regulatory authority.