APIs from UK will need Written Confirmation

As indicated in Brexit: U.K. will become 'Third Country' according to EU Statement, the European Medicines Agency (EMA) and the European Commission intend to provide a series of Brexit related Questions and Answers on the consequences for the pharmaceutical industry. Now, the EMA has published a first set of Q&As

Most of the questions and answers are drug product oriented and are also discussing the location of the establishment of a company in the context of centralised procedures. But question number six gives some information about an important aspect of API distribution: the Written Confirmation.

And the Agency is clear about that: "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." That means APIs imported into the European Union will need to be accompanied by a Written Confirmation from the competent authority of the exporting third country (in this case the UK), pursuant to Article 46b(2) of Directive 2001/83/EC.

Generally, after the withdrawal of the UK from the European Union (EU), "medicinal products manufactured in the UK will be considered imported medicinal products". That means:

  • The Marketing Authorisation Holder (MAH) must be established in the EU (or EEA states Norway, Iceland and Liechtenstein). This will be also the case for centrally authorised medicinal products.
  • The sponsor of an orphan medicinal product designation must be established in the EU (or EEA).
  • The Qualified Person for Pharmacovigilance (QPPV) must reside and carry out his/her tasks in a Member State of the EU/EEA. Also the Pharmacovigilance System Master (PSMF) must be located in the EU/EEA.
  • All production batches imported into the EU/EAA must be analysed/ controlled (again) at a site located in the EU/EEA.
  • Batch release has to be performed in the EU/EAA. As a consequence, a UK based site for batch release has to transfer this activity "to a location established in the Union (EEA) and submit the corresponding variation".

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