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Focus on Regulation

Poland: Post-registration changes required in case of no-deal Brexit

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit.

In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration changes in their medicinal product documentation. These changes concern:

  • the marketing authorisation holder,
  • the place of manufacture / place of import, where batch controls are carried out,
  • the Manufacturer / Importer which releases the batch,
  • the Qualified Person responsible for Pharmacovigilance,
  • the Summary of the Pharmacovigilance System Master File.

The Office has emphasised that the above post-registration changes should be implemented before 30 March 2019 in order to maintain compliance with EU legislation.

At the same time, the Office has asked companies to keep up to date with the information published on the European Medicines Agency (EMA), and of Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) websites.

The new communique constitutes another confirmation (after the Polish Minister of Health’s statement on the effects of Brexit on reimbursement) that the Polish authorities do not plan to adopt any special procedures concerning the implications of Brexit on medicinal products. Therefore, in the case of products registered in Poland, they recommend that companies apply for the relevant post-registration changes as soon as possible, if they have not already done so.

[1]          The communique was issued only in Polish and it can be found on the official website of the office: Communique re: necessary post-registration changes due to Brexit in the documentation of medicinal products in Poland.