This guidance document is the first in a series of further guidance documents to follow which should be published in due course. It concerns information related to the location of the establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites. The guidance relates to both human and veterinary medicines.
Here are the nine questions that are currently being answered together with a short summary of those answers regarding the area of GMP:
1. What if I am a marketing authorisation holder (MAH) established in the UK?
For centrally authorised medicinal products the MAH will need to transfer its marketing authorisation to a holder established in the Union (EEA).
2. What if I am an orphan designation holder established in the UK? (for medicines for human use)
For designated orphan medicinal products the holder will need to transfer its designation to a holder established in the Union (EEA) or it will need to change its place of establishment to a Member State of the Union (or EEA) and submit the corresponding documentation through a change of name and/or address of the orphan designation holder procedure provided the legal entity remains the same.
3. What if I am a UK company with a MUMS (Minor Use Minor Species/limited market) status for my product? (for veterinary medicines)
4. What if my Qualified Person for Pharmacovigilance (QPPV) resides and carries out his/her tasks in the UK?
5. What if my Pharmacovigilance System Master File is located in the UK (PSMF)? (for medicines for human use)
6. What if my manufacturing site of the active substance is located in the UK?
As of the date of the withdrawal of the UK from the Union, active substances manufactured in the UK will be considered imported active substances. From then on APIs shall only be imported into the Union (EEA) if they are accompanied by a written confirmation from the competent authority of the exporting third country which confirms GMP standards equivalent those to the EEA.
7. What if my manufacturing site of the finished product is located in the UK?
As of the date of the withdrawal of the UK from the Union, medicinal products manufactured in the UK will be considered imported medicinal products. For centrally authorized products the MAH will need to specify an authorized importer established in the EEA. The MHA will also need to specify a site of batch control in the Union where each production batch can undergo upon importation a full qualitative analysis of at least all the APIs and all other tests or checks necessary to ensure the quality of medicinal products.
For centrally authorised medicinal products the MAH will need to change the location of its current UK based site of batch control to a location established in the Union (EEA) and submit the corresponding variation.
8. What if my batch release site is located in the UK?
The qualified person of the manufacturing and importation authorisation holder is responsible to certify that each batch of a medicinal product intended to be placed on the EEA market was manufactured in accordance with EU GMP requirements and the marketing authorisation. For centrally authorised medicinal products the MAH will therefore need to transfer its current UK based site of batch release to a location established in the Union (EEA) and submit the corresponding variation.
9. I am a UK based SME, would I still have access to financial and administrative assistance in accordance with Commission Regulation (EC) No 2049/2005 (the ‘SME Regulation’)?
The Q&As will be further updated and complemented in the near future. Click here for a detailed look at the document.
This guidance document is the first in a series of further guidance documents to follow which should be published in due course. You will find all information and documents concerning the UK`s withdrawal from the European Union here on the EMA website.