Dossier submission in the UK after Brexit

  • Bhavika Patel MS
  • Niranjan Kanaki K.B. Institute Of Pharmaceutical Education and Research, Sector 23,Near GH 6, Gandhinagar, Gujarat, India
  • Bhavik Joshi
  • Maitreyi Zaveri


The withdrawal of the United Kingdom (UK) from the European Union (EU), commonly known as Brexit, occurred on January 31, 2020, triggering a transition period until December 31, 2020, during which the UK and EU negotiated their future relationship. Brexit has brought significant changes to regulatory frameworks, particularly in the pharmaceutical sector. This article examines the transition of dossier submission procedures in the UK following Brexit, focusing on the implications for marketing authorizations (MAs) and pharmacovigilance. The Medicines and Healthcare Products Regulatory Agency (MHRA) transitioned to an independent regulatory body, establishing new guidelines for pharmaceutical companies seeking MAs in the UK. Key changes in marketing authorization routes include the conversion of centrally authorized products (CAPs) to UK MAs, the introduction of the Decentralized and Mutual Recognition Reliance Procedure (MRDCRP), and the implementation of a 150-day assessment timeline for national procedures.

This article compares dossier requirements before and after Brexit in the UK and highlights pharmacovigilance requirements post-Brexit, emphasizing adjustments to reporting obligations, Qualified Person for Pharmacovigilance (QPPV) responsibilities, and the establishment of UK-specific Pharmacovigilance System Master Files (PSMFs). Additionally, it addresses the dossier Module 1 administrative information requirements to provide a comprehensive overview of the changes in regulatory procedures in the UK pharmaceutical sector following Brexit.

Overall, the article aims to serve as a valuable resource for industry professionals, regulatory experts, and other stakeholders seeking clarity on the regulatory changes and their implications for pharmaceutical products in the UK following Brexit.

Keywords: Brexit, Transition period, Marketing authorization, Medicines and Healthcare Products Regulatory Agency (MHRA), Decentralized and Mutual Recognition Reliance Procedure (MRDCRP), National procedure, pharmacovigilance, Qualified Person, Pharmacovigilance, Pharmacovigilance System Master Files (PSMFs), Qualified Person for Pharmacovigilance (QPPV), PSUR


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1. Wikipedia contributors. Brexit [Internet]. Wikipedia; 2020 Jan [updated 2022 Mar 29; cited 2024 Apr 11]. Available from:
2. Regulatory Affairs Professionals Society. The UK Regulatory Landscape Post-Brexit [Internet]. Regulatory Affairs Professionals Society; 2021 May [cited 2024 Apr 13]. Available from:
3. Certara. Medicines and Medical Devices Post-Brexit [Internet]. Certara; 2023 Feb [cited 2024 Apr 10]. Available from:
4. Voisin Consulting Life Sciences. How to Overcome the Regulatory Challenges Due to Brexit [Internet]. Voisin Consulting Life Sciences; [cited 2024 Apr 12]. Available from:
5. European Medicines Agency. Practical Guidance on Procedures Related to Brexit for Medicinal Products for Human and Veterinary Use within the Framework of the Centralised Procedure [Internet]. European Medicines Agency; 2020 Mar 16 [cited 2024 Apr 12]. Available from:
6. UK Government. Decentralised and Mutual Recognition Reliance Procedure for Marketing Authorisations [Internet]. UK Government; 2021 Jan 4 [cited 2024 Apr 12]. Available from:
7. UK Government. Established Medicines Marketing Authorisation Application Process Changes [Internet]. UK Government; 2024 Feb 28 [cited 2024 Apr 10]. Available from:
8. UK Government. International Recognition Procedure [Internet]. UK Government; 2024 [cited 2024 Apr 11]. Available from:
9. SlideShare. Post-Brexit Pharmacovigilance in UK [Internet]. SlideShare; 2024 [cited 2024 Apr 11]. Available from:
10. UK Government. Guidance on Pharmacovigilance Procedures [Internet]. UK Government; 2022 Oct 28 [cited 2024 Apr 5]. Available from:
11. Pharmaceutical Information & Pharmacovigilance Association. Pharmacovigilance [Internet]. pipaonline; 2024 [cited 2024 Apr 11]. Available from:
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How to Cite
Patel, B., N. Kanaki, B. Joshi, and M. Zaveri. “Dossier Submission in the UK After Brexit”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 2, June 2024, pp. 46-57, doi:10.22270/ijdra.v12i2.674.

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