MHRA updates numerous procedural guidance documents

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated several procedural guidance documents with more detailed information relating to application processes. The changes are summarised below.

5-digit company number

Marketing Authorisation Applications (MAAs) submitted to the MHRA via their submissions portal require the applicant to have a 5-digit company number in order to register on the portal. For those that do not already have this number, they can request one from the MHRA by emailing Reference.Data@mhra.gov.uk. This applies to  the Unfettered Access Procedure (UAP) for Northern Ireland approval, the decentralised and mutual recognition reliance procedure (MRDCRP) and the European Commission Decision Reliance Procedure (ECDRP). The guidance documents for each of these procedures have been updated accordingly.

Orphan medicinal products

Following the recent publication of the UK orphan register, the guidance on orphan medicinal products in Great Britain (GB) has been updated to provide further detail on the market exclusivity period. At the date of its creation, the register only contained centrally authorised European Union (EU) marketing authorisations (MAs) converted into GB MAs. The market exclusivity periods for these products will not be changed in any way by the conversion process. Furthermore, if a Change of Ownership application is submitted, the orphan designation will automatically transfer with no impact on the market exclusivity period. An additional update to the guidance includes a section noting that the UK Licensing Authority can request a reduction in the exclusivity period from 10 to 6 years in cases where the orphan criteria are no longer met in relation to the medicinal product.

Under normal circumstances, a product will be removed from the Orphan Register when its period of market exclusivity for an indication ends which causes its orphan designation to expire. However, if other authorised orphan indications are still within their period of exclusivity for that product, it will remain on the register. Only once all orphan designations for an approved medicine have expired or been withdrawn by the sponsor with the product be removed from the register.

To view the full guidance document on orphan medicinal products, click here.