Guidance for Great Britain (England, Wales and Scotland) Marketing Authorisation Applications for similar biological products (biosimilars) from 1 January 2021
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 same principles that are applicable now. Northern Ireland will follow the EU acquis and MHRA will regulate applications for bio similar from 1 January 2021 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 December 31st 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 the date of UK exit from the EU will continue to be applicable in the UK.
As part of the supporting data package, Great Britain will continue to accept data generated on reference product sourced in accordance with the ‘Guideline on similar biological medicinal products CHMP/437/04 Rev1’.
We have more information about biosimilar products.
Guidance for Great Britain Marketing Authorisation Applications for Advanced Therapy Medicinal Products (ATMPs) from 1 January 2021
From 1 January 2021, 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) from 1 January 2021
From 1 January 2021, the MHRA will continue 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.
This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.
Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
How traditional herbal medicines and homoeopathic medicines will be treated by the MHRA from 1 January 2021.
New rules for January 2021
The UK has left the EU, and the transition period after Brexit comes to an end this year.
This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.
For current information, read: Decide if your product is a medicine or a medical device
You can also read about the transition period.
Traditional herbal medicines
For issues relating to place of establishment, variations and other regulatory issues which would previously have been regulated at EU-level, please refer to guidance on marketing authorisations (MAs)
From 1 January 2021, the MHRA may expand the list of countries from which it will accept evidence for traditional herbal medicines. Currently for traditional herbal registration evidence has to be provided that the product or a corresponding product has been used for a period of 15 years within the EU/EEA.
From 1 January 2021, the MHRA may be able to accept the 15 years of traditional evidence from a wider range of countries in addition to EEA countries. Suitable countries will be those that have a level of pharmacovigilance equivalent to that of the UK. This is to ensure that any safety issues have been properly identified to support the traditional use of the product. The MHRA will publish a list of suitable countries for this purpose which will be updated as new entries arise.
This provision will not apply to traditional herbal medicines intended to be marketed in Northern Ireland. For these products, traditional use evidence will need to be provided that the product or a corresponding product has been used for a period of 15 years within the EU/EEA. The MHRA may publish its own list of herbal substances, preparations and combinations for use in traditional herbal medicines. This will include the entries in the existing EU List and the MHRA list will be updated as new entries arise.
Only the EU list will be relevant for applicants wanting to apply to market a traditional herbal medicine in Northern Ireland.
Homoeopathic medicines
For issues relating to place of establishment, variations and other regulatory issues which would previously have been regulated at EU-level, please refer to guidance on marketing authorisations (MAs).
From 1 January 2021, the definition of a homoeopathic medicinal product will be expanded. The definition will cover products prepared from homoeopathic stocks made in accordance with a homoeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of a description there, in accordance with a procedure described in the British pharmacopoeia or in a pharmacopoeia used officially in a country that is included in a list published by the MHRA.
It is anticipated that the list will include the:
- British Pharmacopoeia
- European Pharmacopoeia
- Pharmacopoeia used officially in an EEA country
The above list will be updated as new entries arise.
This provision will not apply to products marketed in Northern Ireland and the current EU definition of a homeopathic medicinal product will remain.
This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.