Celebrating 10 years of innovative, global,
Regulatory solutions & services for Life Sciences industry

MRP/DCP National/Central Procedure

The UK has formally left the European Union on January 31, 2020 and has become a 3rd country to the EU. On February 1, 2020 a transition period has started which ends on December 31, 2020.

During the transition period, EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ will still be applicable to the United Kingdom, meaning that pharmaceutical companies can still perform activities within the UK until the end of the year.

Companies have until December 31, 2020 to form the required changes to make sure that their authorised medicines suit EU law and may remain on the EU market. Marketing authorisation holders/ applicants can still be established within the UK and Qualified Persons for Pharmacovigilance (QPPVs) and Pharmacovigilance System Master Files (PSMFs), also as manufacturing/quality control testing/batch release sites, can still be based within the UK until the top of 2020.

The withdrawal agreement foresees that following its departure from the EU on January 31, 2020, the United Kingdom will not participate in the EU institutions and their decision-making. For the CMDh, this suggests that as of February 1, 2020, nobody who represents the United Kingdom or is appointed or nominated by the United Kingdom can systemically participate within the CMDh meetings. During the transition period, the United Kingdom won't be ready to act as RMS in MRP/DCP, but the United Kingdom can participate in MRP/DCP as CMS.

Latest Resources

  • Blogs

    Brexit: The MHRA and The Proposed eSubmission Portal

    Read More
  • White Papers

    Impact of COIVD – 19 on FMCG Supply Chain Regulatory Compliance

    Read More
  • Case Studies

    Expedited Product Classification and NIOSH Certification for N95 Respirator

    Read More

What our Clients Say?

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Quick Inquiry
x