BREXIT – Temporary exemption for transfer of batch control testing to the EU/EEA after March 29, 2019
06.03.2019
Marketing authorisation holders who are unable to transfer their batch testing site from UK to an EU member state before March 29, 2019 may apply for a temporary, time-limited exemption to the implementation of aforementioned transition.
The exemption may be requested in accordance with the conditions set out in the European Commission document "Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products", using the form published by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
The request for exemption should be submitted as soon as possible and no later than March 29, 2019. The request is submitted to the relevant national competent authority for medicinal products approved through national procedure. For medicinal products approved through mutual recognition / decentralised procedure (MRP/DCP), the request is submitted to the reference member state (RMS) with concerned member states (CMS) listed in the notification e-mail copy (CC).
The procedure for applying for an exemption is described in detail in the document Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP, in response to question number 32 "Can I request a delay for transfer of batch control testing to the EU/EEA?".
Taking into account all of the above mentioned, a filled, signed and scanned form must be submitted to HALMED via email or Eudralink to the address Adrijana.IlicMartinac@halmed.hr.
If the request for exemption is justified HALMED will notify the marketing authorisation holder of the acceptance in the shortest possible time.
For medicinal products authorised through centralised procedure (CP), the request for exemption is submitted to the European Medicines Agency in accordance with guidelines available under the link: https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies.
All additional information regarding Brexit is available on the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) website.
