Guidance

Guidance on licensing biosimilars, ATMPs and PMFs

The way you apply to licence biological products has changed

From:
Medicines and Healthcare products Regulatory Agency
Published
31 December 2020
Last updated
10 May 2021 — See all updates

Guidance for Great Britain (England, Wales and Scotland) Marketing Authorisation Applications for similar biological products (biosimilars)

The guidance is written on the basis of Reg 53 of The Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period.

From 1 January 2021 the MHRA will regulate biosimilar products according to the MHRA guidance on the licensing of biosimilar products. Northern Ireland is following the EU acquis and MHRA will regulate applications for biosimilars accordingly.

New applications to Great Britain will be assessed at national level and should be submitted using existing procedures for national applications.

For biosimilar applications submitted after 1 January 2021, the application can only be made with reference to a product that falls within the definition of reference medicinal products in regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.

These will be products that have been authorised for at least 8 years. They can include products authorised in the UK and those authorised by conversion from EU Marketing Authorisations (MA). It also includes products for which an EU marketing authorisation was in force on 31 December 2020 but which did not convert into Great Britain marketing authorisations as the holder opted out of that process, and products for which an EU marketing authorisation has ceased to be in force for reasons not related to safety, quality or efficacy.

Data and market exclusivity period entitlements for reference medicinal products approved before 1 January 2021 continue to be applicable in the UK.

As part of the supporting data package, Great Britain continues to accept data generated on reference product sourced in accordance with the MHRA guidance on the licensing of biosimilar products.

Guidance for Great Britain Marketing Authorisation Applications for Advanced Therapy Medicinal Products (ATMPs)

ATMPs will be regulated nationally in relation to Great Britain by the MHRA according to the same principles that previously applied. In Northern Ireland ATMPs will continue to be regulated according the EMA’s Centrally Authorised Procedure.

This means that 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.

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.

Definitions of individual classes of ATMPs will remain unchanged and classification of ATMPs in the UK will be undertaken by the MHRA in accordance with the legislation and current guidance.

Accordingly, ATMPs will continue to be classified into either:

  • gene therapy medicinal products
  • somatic cell therapy medicinal products
  • tissue engineered products

What to do if you are uncertain about classification

If you are uncertain about the classification of your product fill out the ATMP advice form or consult the Reflection paper on classification of advanced therapy medicinal products (EMA/CAT/600280/2010 rev.1).

Guidance for Plasma Master Files (PMFs) and Vaccine Antigen Master Files (VAMFs)

The MHRA continues to recognise the existing PMF and associated inspections until further notice.

The supervision of the PMFs may eventually be fully transferred into a national system. This will be communicated by the MHRA at a later date. In the interim, we require the PMF holder to notify the MHRA of the outcome of the annual updates within 4 weeks of the completion of the update.

For variation applications submitted to the EMA, the PMF holder must notify the MHRA of the submission and determination outcome of such an application within 4 weeks of the submission and determination dates, respectively.

MHRA reserve the right for further review where an EU assessment report is deemed to indicate significant public health issues that are insufficiently addressed at European level.

MHRA will issue guidance on the transfer of PMFs to the MHRA database when this becomes relevant, but the data requirements will be in accordance with those currently in place in the EU.

No VAMF is in use in the UK at present. Applicants proposing such a submission, which will be subject to the same standards and criteria as apply now, should contact the MHRA for further guidance.

Contact

For further information, please email our Customer Services Centre at RIS.NA@mhra.gov.uk. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020
Last updated 10 May 2021 + show all updates

  1. Updated text to link to new 'Guidance on the licensing of biosimilar products'.

  2. First published.

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