MHRA Grants 12-Year Exclusivity for Romvimza in UK

• The Human Medicines Regulations 2012 govern orphan market exclusivity in the UK.
• A 10-year period of exclusivity is granted from marketing authorisation, with potential for a two-year extension if paediatric data requirements are met.
• Products with EU orphan designation may be considered for Great Britain orphan marketing authorisation, but only in the absence of an active EU designation.
• The Orphan Register has been updated to reflect changes to listings and exclusivity dates.

Under regulation 58D of the Human Medicines Regulations 2012 (as amended), a period of 10 years orphan market exclusivity is awarded from the date of marketing authorisation by MHRA.

The Human Medicines Regulations 2012 (as amended) govern orphan market exclusivity in the UK. Under regulation 58D, a 10-year period of exclusivity is granted from the date of marketing authorisation by the MHRA. This can be extended by an additional two years if paediatric data requirements are met, as per regulation 58C(2). The scope of orphan market exclusivity is tied to the authorised indication for each product. Products with EU orphan designation may be considered for a Great Britain orphan marketing authorisation, but only in the absence of an active EU designation. A UK-wide orphan marketing authorisation requires no pre-authorisation orphan designation in Great Britain.

The Orphan Register has undergone several updates recently. Romvimza (14mg, 20mg and 30mg capsules) was added to the register with an OD1 designation. IMCIVREE was also added, along with amendments to Takhzyro 300 mg and Lonapegsomatropin Ascendis Pharma's product name change to Skytrofa. Reblozyl and Vyloy 300mg were added, while Mepsevil was renamed Mepsevii. Kanuma and Strensiq were reinstated to the register after being removed. Amvuttra's expiry date was amended, and ZYNYZ was added to the register. Koselugo 5 & 7.5 mg granules in capsule for opening were also included.

The Orphan Register lists products with orphan market exclusivity, including their corresponding dates. The register has been updated to reflect changes to these listings. For instance, the expiry date for Lutathera's orphan market exclusivity was amended, while Kinpeygo's orphan indication was updated. Wayrilz 400mg film-coated tablets and Vyjuvek 5×10^9 plaque forming units/mL suspension and gel for gel were added to the register. Hepcludex also underwent an update.

Lawyers and compliance officers should review the updated Orphan Register to ensure their clients' products are correctly listed and that any market exclusivity dates have been accurately recorded.

Source: Original reporting via GOV.UK