Brexit // Where do we go from here?
A cautious agreement has been reached for the future relationship between the European Union and Great Britain. Here are some facts about the given Brexit scenario regarding the pharmaceutical and pharmacy sector:
The agreement contains specific provisions for both the pharmaceutical and pharmacy sectors, which are not as comprehensive as hoped:
- There will be separate Marketing Authorisation Systems for medicinal products.
Neither a Mutual Recognition of the Marketing Authorisation decisions nor a transitional period was agreed upon.
- There is no Mutual Recognition Agreement on batch release or testing.
Upon importation of medicinal products from Great Britain to the European Union, an EU re-testing needs to be performed and based thereon, batch release must be carried out by a Qualified Person according to Annex 16 EU GMP Guideline.
GMP certification
In Annex TBT-2, Article 5 the Mutual Recognition of official GMP-documents (including certifications or authorisations) of manufacturers within the scope of inspections of the respective Parties is facilitated; the valid legal bases the manufacturing facility must comply with, are listed in Annex TBT-2, Appendix B and includes laws, regulations and technical guidelines accepted by both Parties. The Mutual Recognition embraces not only GMP documents and certification of facilities within but also outside the respective Party’s territory, the latter being voluntary.
Further regulations concern, among other things, non-recognition in justified individual cases and the performance of own inspections on the territory of the other Party: The authority of one Party may, under certain circumstances, decide not to recognise an official GMP document for manufacturing facilities issued by the authority of the other Party on the basis of evidence on non-conformity, deficiencies or insufficiencies.
Inspections
Both European Union and Great Britain grant each other’s authorities the right to conduct their own inspections of manufacturing facilities that have been certified as compliant by the other Party as per Annex TBT-2, Article 7, given that a curtesy notification is issued to the respective Party’s authority at least 30 days in advance of the planned inspection. The time frame may be shortened in cases of urgency and both Parties agree on the possibility of carrying these out as joint inspections.
Fallout
So, where do we go from here? Manufacturer’s and pharmaceutical Companies both in the European Union as well as Great Britain shift their Supply Chain accordingly, of course. Many anticipations have proved to be correct, though their execution remains to be harmonised individually:
Where shall established Marketing Authorisations apply? Is a shift, transfer or variation necessary to be compliant? Most Supply Chains are implemented internationally, with contract manufacturing organisations located in different territories. The recognition of their GMP certification, if issued by the other Party’s authorities, needs to be individually confirmed with their own Party’s applicable authority. This has not only an impact on the compliance with GMP, but also with the aforementioned Marketing Authorisation. Lastly, imported medicinal products from Great Britain to the European Union need to be re-tested within the European Union and, if satisfactory and within specification, released to market by a Qualified Person.
The Tentamus Group offers a qualified network for specialised analyses within both Parties’ territories and excellent knowledge and experience with (re-)testing, importation and batch release.
If you would like to ensure that your Supply Chain remains compliant and effective, TentaConsult may offer you support in the assessment of established and development of new processes, including the qualification of contract manufacturing or testing organisations. TentaConsult offers QP services both individually as contracted Qualified Person under your Importation Authorisation (MIA), and also together with DSI-pharm, Quality Services International GmbH.
DSI-pharm is a GMP-certified and well-experienced laboratory for testing of medicinal products within the Tentamus Group, offering not only release and stability testing, but also QP release of these tested batches under their MIA.
For all necessary activities in the UK or access to them, the experienced and excellently equipped laboratories of Tentamus UK – flanked by all necessary services for you and your products – are already at the ready.
We don’t have to set anything up, we are already on site for you! It would be great if we could demonstrate it to you soon!
Your contact partner:
Ronja Loy
Senior Consultant
+49 251 928715-63
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