News Category: Regulatory news
The CMDh has published updated guidance on reference medicinal products (RefMPs) in the latest version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP.
The Practical Guidance, in particular its Annex on Medicinal Products, aims to provide procedural and practical guidance and addresses the implications of the Withdrawal Agreement and the Trade and Cooperation Agreement between the EU and UK.
Specifically, for issues relating to RefMPs, the HPRA wishes to draw your attention to the responses to Questions 34 and 39 of the document.
Guidance on dealing with new DCPs and variations that are cross-referring to UK marketing authorisations for product information alignment is addressed in the response to Q39, and also included in Section 4.1 of the CMDh minutes, January 2021.
For new marketing authorisation applications, a European reference product (ERP) should now be used unless the exceptional case outlined in Question 34 of the CMDh Brexit guidance arises. However, for ongoing generic new applications, while the UK ERP may be kept as being the RefMP of the original application, the applicant should align the product information to a suitable RefMP within the global marketing authorisation.
Details of variation classifications are included in the CMDh minutes, which also highlight the need to keep product information up to date.
The choice of RefMP is the responsibility of the applicant / MAH and the HPRA cannot provide specific advice. General reference medicinal product related queries can be submitted to submissions@hpra.ie.