As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.
The main updates are the following:
- A specific guideline on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP has been published.
- Update in Question 20. Update in Question 20, regarding the GMP certificates issued by UK authorities after the end of the transition period: The GMDP Inspectors Working Group have agreed a harmonised risk-based approach for the use of GMP Certificates issued by UK authorities after the end of the transition period to confirm GMP compliance for the purpose of regulatory submission and importation from third countries. This approach may be used by the EU competent authorities of the EU without prejudice to national legislation. As such, valid GMP certificates for sites located in Great Britain and in other 3rd countries issued by UK authorities after the end of the transition period can be submitted by companies for the purposes of demonstrating GMP compliance in the context of regulatory submissions and/or importation requirements.
The EU Supervisory Authority will verify the submitted UK GMP certificate to ensure that the scope encompasses the facilities, dosage forms and/or manufacturing processes for which it is being submitted and whether other GMP compliance or non-compliance information is available from other EU or international authorities. The EU supervisory authority will assess and confirm the GMP compliance of the site. In accordance with Article 111 of Directive 2001/83/EC and Article 80 of 2001/82/EC, each Supervisory Authority can decide, at any moment in time, to perform an inspection of a manufacturer if it considers that there are grounds for suspecting GMP non-compliance.
The GMDP Inspectors Working Group will re-assess the applicability of this risk-based approach periodically.
- Update in Question 30, regarding activities located in the UK after the end of transition period: After the end of the transition period products with MAH, batch release sites, local representative, QPPV, PSMF or batch control sites still (only) located in the UK (or Great Britain for batch release sites and batch control sites) may no longer be placed on the market in the EU/EEA. Marketing authorisation holders have to submit variations to replace these activities from the UK or GB site to an EU/EEA site or UK(NI) site, as applicable. Only after the activities have been transferred to sites in the EU/EEA the products may be placed on the market in the EU/EEA again.
Products with these activities still located in the UK but already released and placed on the market on the territory of the EU/EEA or UK before the end of the transition period, may be further made available on the market of the EU/EEA in line with Art 41 of the Withdrawal Agreement and do not have to be re-called from the market.
- New question added: Question 37. If I still have UK sites mentioned in the dossier after the end of the transition period in addition to EU sites, e.g. alternative batch release or batch control sites, how can I remove these after the end of the transition period?
- Alternative sites still located in the UK(GB) should be removed from the MA via the respective variation procedure according to the classification guideline.
Asphalion is an International Scientific and Regulatory Affairs Consultancy with extensive knowledge in MRP/DCP procedures and closely monitors every movement around Brexit in order to be able to better advise and guide marketing information holders on this transition. If you have any questions do not hesitate to contact us at: [email protected]
