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Life Sciences

EMA Issues Brexit Guidance To Pharma

Pharmaceutical companies selling their products in the UK need to consider the impact Brexit will have on their operations. Some changes will need to be made before the UK leaves the European Union on March 30, 2019.

In a press release, the European Medicines Agency (EMA) said:

“The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area after the UK withdraws from the EU. The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019. It should be read in conjunction with the Questions and answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure published in May 2017.”

The following questions are answered in the document:

1. Can I group Brexit-related variations?

2. How to classify Brexit-related changes impacting on the manufacturing activities for my medicinal product?

3. Can I submit several changes relating to manufacturing of the active substance or finished product under a single Type II variation?

4. How can I submit an application for the transfer of a marketing authorisation for my products and what would the applicable fees be?

4a. How to handle planned or ongoing regulatory procedures during the transfer of marketing authorisation?

4b. Is it possible to submit a transfer of the orphan designation in parallel with a transfer of the marketing authorisation?

4c. Is there any possibility to simplify transfer applications when these are Brexit related?

4d. Can requirement for mock-ups be waived for Transfers?

5. How can I submit a transfer or change in the name/address of an orphan drug designation sponsor for my products? (for medicines for human use)

6. How do I submit changes to Qualified Person for Pharmacovigilance (QPPV) and/or changes in the Pharmacovigilance Master File (PSMF)location? (for medicines for human use)

7. How do I submit changes to QPPV? (for veterinary medicines)

8. How do I submit changes to the person responsible of scientific services and to the person responsible for batch recall and quality defects? (for medicines for human use)

9. How do I submit changes to the person responsible for batch recall and quality defects? (for veterinary medicines)

To read the guidance, click here.

If you are interested in learning how Perficient can help you prepare for Brexit or help you evaluate the impact of new and proposed regulatory rules on your organisation, please reach out.

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Indy Ahluwalia

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