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Brexit and the MRDCRP - update on 5-digit company number

On 23 February 2021, an update was published to the British Medicines and Healthcare products Regulatory Agency's (MHRA) Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisations which was initially published on 4 January 2021. The update sets out how companies that do not have a company code can attain one. In this article, we outline the submission process, including the new update.

Following Brexit, MRDCRP provides a way to apply for marketing authorisations for medicinal products which have already been approved in the European Union (EU). The intention is that acceptable authorisations should be granted within 67 days of validation by the MHRA. Products which are granted in European Union Member States through national procedures only however, may not be approved through the MRDCRP. If major objections are raised and remain outstanding at the end of the 67 day period, the standard British National Procedure will apply.

Recently, the MHRA have advised that the 5-digit company number required to allow registration on the MHRA Submissions Portal should be requested directly from the agency via e-mail to Reference.Data@mhra.gov.uk. This is necessary in order to obtain a product license number prior to the actual submission.

The entire dossier as approved for marketing in the EU Member States, including the full company responses to Reference Member State / Concerned Member States questions, should be submitted to the MHRA as one electronic Common Technical Document sequence through the MHRA Submissions Portal.

The working documents folder for the submission should include all assessment reports and end of procedure documents that were for the original EU authorisation, the proposed product information (as a MS Word file) as well as the market authorisation grant letter approved in the Reference Member State. Submissions will attract fees depending on the scope of the submission (see https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees for detailed information).

Altogether, the MRDCRP provides a clean and fast solution to approve medicines and healthcare products in Great Britain even after Brexit.

Tags

united kingdom, regulation-pharma, regulation, pharmaceuticals

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