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Brexit agreement and pharmaceutical imports from 1.1.2021

12.1.2021

On 24.12.2020 the EU and UK signed a Trade and Cooperation Agreement that took effect from 1.1.2021. EU legislation sees the UK as a so-called third country – a state outside the European Economic Area (except for Northern Ireland – see more below).

With respect to imports of pharmaceuticals this means that registered pharmaceutical products, or those that are subject to a sales licence, or products for clinical study may be imported from the UK to Finland only by an importer that has been granted a licence to manufacture medicines. In addition, batches of pharmaceutical preparations must undergo an inspection in EU territory in accordance with the sales licence of the pharmaceutical preparation and the batches must be certified by a Qualified Person (QP) in the EU area (Medicines Act, Sections 9 and 17). If the batches of medicinal products were certified by a QP in the UK before 31. 12. 2020 the batches do not have to be recertified in the EU.

Officials’ reciprocal GMP approval

With respect to medicines, the EU and UK give reciprocal approval to the GMP inspections conducted in each other’s territory by the actors and their GMP certificates. Both parties have the right to carry out inspections themselves in each other's territory if necessary. In addition, both parties have the right to approve GMP inspections conducted by each other in third countries.

With respect to medicines, the agreement applies to

  • commercial medicines for people and animals, including biological and immunological preparations
  • therapy preparations that have been extensively developed
  • pharmaceutical preparations for use on people and animals
  • research preparations

Exceptions

As of 1.1.2021 EU legislation will be applied to Northern Ireland for the time being (initially for four years). Preparations in Northern Ireland must meet the requirements of EU legislation and the holders of their sales licences must be in the EU or Northern Ireland. Licences for pharmaceutical manufacturers and pharmaceutical wholesalers and GMP/GDP certificates granted by the UK for Northern Ireland can be found in the EU's shared EudraGMDP database.

In addition, concessions have been granted for historical reasons, and for reasons of availability of medicines through 31. 12. 2021 for the following countries: Cyprus, Ireland, Malta, Northern Ireland.

Included in the concessions, under certain conditions are, among others:

  • batches of pharmaceutical preparations or clinical research preparations may exceptionally be imported from Great Britain or via Great Britain to the countries in question with only a pharmaceutical wholesaler's operating licence
  • relief may be granted for quality control for imported batches of pharmaceuticals in order to ensure quality

It should be noted that pharmaceutical packaging in Cyprus, Ireland, Malta, and Northern Ireland must have EU medicine safety features even if they are imported through Great Britain. Exceptionally, individual codes in the safety features of the packaging in question will not be deleted from the EU's common recording system before passing through Great Britian. The codes will be used for securing the pharmaceutical packaging in Cyprus, Ireland, Malta, and Northern Ireland.

Batch release certificates granted by official laboratories (OCABR certificates)

The official certificates (OCABR certificates) granted by the UK for vaccines and blood and plasma products, which are dated after 1.1.2021 are no longer valid in the EU.

More detailed guidelines can be found in instructions from the European Commission or the European Medicines Agency.

Further information

EMA Brexit instructions for companies, to be updated

EMA Q&A for Northern Ireland, version 2, 11.12.2020

EC & EMA Notice to Stakeholders, version 3, 13.3.2020

EC Notice: markets historically dependent on UK medicines, 22.12.2020

Brexit Agreement, Annex on TBT-2 medicines, 31.12.2020

Ask more

  • Mervi Saukkosaari, Senior Inspector, Head of Section, tel. +358 29 522 3261
  • E-mail address format: firstname.lastname@fimea.fi