The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday released new guidelines related to a no-deal Brexit scenario.
Three of the guidelines published are on licensing of biological products such as biosimilars, managing orphan medicinal products and new provisions for homoeopathic medicinal products.
According to the documents related to the licensing of biological products, the MHRA will continue to regulate biosimilar products as per the same principle that is applicable now. New applications will be assessed at the national level and should be submitted using existing procedures for national applications.
Biosimilar applications submitted after exit day can only be made with reference to a product that complies with regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines Regulations 2019.
Application for biosimilar products will also be eligible for the targeted assessment procedure after a final opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has been obtained.
MHRA will regulate the Advanced Therapy Medicinal Products (ATMPs) with the same principles that previously applied. In the case of Plasma Master Files (PMFs) and Vaccine Antigen Master Files (VAMFs), the MHRA will continue to recognise the existing PMF and associated inspections until further notice.
The guidance on UK orphan medicinal products gives advises on the application process, market exclusivity period and paediatrics indications. All medicines, including active and then withdrawn, suspended or expired, that gain a UK orphan marketing authorisation will be listed on the UK Orphan Register.
MHRA will review applications for orphan designation at the time of a marketing authorisation application (MAA) and to qualify for the designation, the companies should meet certain criteria.
The guidance on herbal and homoeopathic products states that the policies regarding both would follow marketing authorisations (MAs) in areas including place of establishment, variations and any other matters ongoing at EU-level on exit day.
MHRA will expand the lists of countries from which it accepts traditional evidence for herbal medicines and homoeopathic medicinal product. The definition will cover products prepared from homoeopathic stocks made in accordance with a homoeopathic manufacturing procedure described in a pharmacopoeia used officially in any of the MHRA listed countries.