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

Renewing Marketing Authorisations for medicines from 1 January 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK's medicines regulator from 1 January 2021. Your MAs will remain in force until a decision has been made on your renewal applications. If a final decision has been made on your renewal but it hasn't been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome.

The MHRA will continue to accept reduced submission requirements for renewals of MAs for products authorised under Article 10.1. From 1 January 2021, you should continue to submit your renewal applications for conditional MAs 6 months before they expire. For Great Britain MAs, the application should be submitted to the MHRA, who will consider the application in accordance with new regulation 66B of the Human Medicines Regulations 2012. The same applies to converted EU MAs that were granted as conditional MAs. Where the MA has remained in line with the EU or Northern Ireland MA , MHRA - will accept the same renewal application as submitted.

Source: MHRA guideline on  Renewing Marketing Authorisations for medicines from 1 January 2021

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