It is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law. In March 2020, EMA also updated Brexit-related guidance for the benefit of the pharmaceutical companies. As per the guidance, the following entities can be located in the UK until the year-end:

  • Marketing Authorization Holders (MAH) and applicants
  • Orphan designation holders
  • Companies' manufacturing and batch release sites
  • Minor use/minor species (MUMS)/limited markets classification holders
  • Qualified persons for pharmacovigilance (QPPVs)

Guidance on Centrally Authorized Products:

EMA and the European Commission are maintaining a series of guidance documents for Centrally Authorized Products of pharmaceutical companies, that contain information on

European Commission/EMA Notice to Stakeholders with respect to:

  • Legal considerations after the transition period such as marketing authorizations and procedural issues, manufacturing and importation of finished products and active ingredients
  • Provisions for products placed on the market before the end of the transition period
  • Rules applicable in Northern Ireland after the transition period

EMA practical guidance includes information such as:

  • Necessary changes to the market authorizations and orphan designations
  • Impact on ongoing procedures, compliance assessments
  • Impact on hybrid, generic and biosimilars applications
  • Submission of the UK safety information
  • The UK nationally authorized products in European procedures

Guidance on Nationally Authorized Products:

The Co-ordination Group for Mutual Recognition and Decentralized Procedure - Human (CMDh) released the following guidance documents for the human medicine marketing authorization holders of nationally authorized products.

Notice to stakeholders for human medicine includes:

  • The legal situation as of the end of the transition period
  • Separation provisions of the Withdrawal Agreement 
  • Rules applicable to Northern Ireland as of the end of the transition period

Practical guidance related to human medicinal products includes information on:

  • Guidance on the submission of changes and related fees
  • Additional considerations regarding products placed on the market before the end of the transition period
  • Applicable rules in Northern Ireland after the transition period

To conclude, the marketing authorization holders for pharmaceutical products are required to adapt to the suggested processes before the end of the transition period in order to ensure their products’ continued compliance. Stay Informed! Stay Compliant!


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