How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?

The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance which outlines the procedures that the MHRA plan to introduce to regulate biological medicines in the event of a no-deal Brexit. The guidance covers United Kingdom (UK) marketing authorisation for biosimilars, marketing authorisation applications for advanced therapy medicinal products (ATMPs) and plasma master files (PMF) post Brexit.

If the UK were to leave the European Union (EU) without a deal, the MHRA stated that they will continue to regulate biosimilar products according to the principles that are applicable now. These principles are covered in regulation 58 of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 amending Reg 53 of The Human Medicines Regulations 2012. Any new applications will be assessed at national level and should be submitted using existing procedures for national applications. After a final opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has been obtained, applications for biosimilar products will also be eligible for the targeted assessment procedure. The guidance then goes on to discuss biosimilar applications that are submitted after exit day.

ATMPs will also be regulated nationally by the MHRA according to the same principles that previously applied, if the UK leaves the EU without a deal. The principles are outlined in regulation 4 of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/XXXX); Reg 2A of The Human Medicines Regulations 2012 (SI 2012/1916) as amended. Consequently, marketing authorisation applications for ATMPs will be assessed in accordance with the general provisions in place for the licensing of medicines, taking the specific requirements for this group of medicines into account. The MHRA have stated that “data, traceability, exemptions from licensing, packaging and post-authorisation requirements will remain unchanged from the current EU requirements and will be transposed into UK law.”

The MHRA guidance also outlines the procedures that the MHRA will take and or/introduce regarding PMFs and vaccine antigen master files (VAMFs) after Brexit. The guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.

To read the MHRA’s guidance on licensing of biological products: biosimilars, ATMPs and PMFs in a no-deal Brexit, please click here.