Medicinal Product Regulation Post Brexit

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) Guidance, published on 1 September 2020, has outlined how the UK medicinal product industry will be regulated once the transition period after Brexit ends on 31 December 2020 (Guidance).

The Guidance states that from 1 January 2021, the MHRA will be the UK’s stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which were previously taken or carried out at EU-level. Decisions on Marketing Authorisation (MA) applications made through the European procedures to market products in Northern Ireland will remain with the European Medicines Agency (EMA). We outline some of the main action points which industry players will have to consider before placing their medicinal products on the market in the UK from 1 January 2021.

Centrally Authorised Products Marketing Authorisations (CAP MAs)

CAP MAs will automatically be converted into UK Marketing Authorisations (UK MAs) effective in Great Britain (excluding Northern Ireland) on 1 January 2021 and they will be issued with a UK MA number.
Currently pending and future applications for CAP MAs may continue to include Northern Ireland. If the application is successful, this authorisation will cover marketing of the product in Northern Ireland.
CAP MAs converted from EU to UK MAs will be treated as if they were granted on the date the corresponding EU Marketing Authorisation (EU MAs) was granted. The renewal date will stay the same.
EU MA holders can choose to opt-out of the conversion process for all or some of their CAPs by notifying the MHRA, in writing, after which UK MAs will be revoked. To opt out the EU MA holders must let the MHRA know by 21 January 2021.
If the EU MA holder chooses to opt-out, their product(s) will no longer be licensed and must not be marketed in Great Britain (England, Scotland and Wales). The MHRA will publish a list of products that have opted out and not been converted as a result of this process.
Within the period of one year starting on 1 January 2021, the UK MA holder must submit certain information to the MHRA for each converted EU MA.[1]

MAs granted through mutual recognition or decentralised procedures

Existing products that received an MA for the UK via the mutual recognition or decentralised procedure routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA.
The Guidance states that if you’ve submitted renewals for MAs granted through mutual recognition or decentralised procedures and have not got a decision before 1 January 2021, you will not need to resubmit them. If a final decision has been made on your renewal, but it hasn’t been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome. Where a final decision has not been made, the MHRA will ensure that the renewal process is concluded and processed by the appropriate route.

National contact person for pharmacovigilance

The appropriately qualified person responsible for pharmacovigilance (QPPV) for UK MA holders can reside and operate in the EU or the UK. They will be responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products.
The Guidance states however if you choose to establish a QPPV who resides and operates in the EU, you must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. This person should have access to the reports of suspected adverse reactions referred to in regulation 187 of the Human Medicines Regulations 2012 (as amended) and the pharmacovigilance system master file (PSMF) for UK authorised products. The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.
There will be a temporary exemption in place which allows 12 months from 1 January 2021 to appoint a national contact person for pharmacovigilance that resides and operates in the UK.

Location of pharmacovigilance system master file

For UK MA holders, the PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the Human Medicines Regulations 2012 (as amended) are accessible.
The PSMF needs to be permanently and immediately available for inspection at the stated location in the UK.

Packaging requirements

Once a UK MA is issued then the MA holder will have 24 months from the end of transition period to submit appropriate amended artwork and then a further 12 months, 36 months total, to transition to releasing stock in compliant packaging.
The MHRA will continue to allow multi-language packaging provided that the entirety of the information is compliant with the UK requirements.

Conditional Marketing Authorisation:

The MHRA will introduce a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products for unmet medical needs in Great Britain from 1 January 2021. The EU, EEA and Northern Ireland will continue to submit to the EMA under the CAP scheme as before.

Importing and Responsible Person (Import)

There will be an approved country for import list. Initially, this will be countries in the European Economic Area (EEA). Current wholesale dealers’ licences will remain in force from 1 January 2021.
Wholesaler dealers’ licences will allow for the importation of medicinal products from a country which is on the approved list.
In order to continue to import medicinal products from a country which is on an approved country for import, the Guidance lists two actions that need to be undertaken:
within 6 months from 1 January 2021, notify MHRA in writing of your intention to continue to import medicinal products from a country on the list
within 2 years from 1 January 2021, nominate and have named on your wholesale dealer’s licence a Responsible Person (import) (RPi) who will carry out specific functions
The RPi is responsible for implementing a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain from countries on an approved country for import list. The RPi may delegate the activity of checking QP certification has taken place, but remains responsible for ensuring the effectiveness of these checks.
Medicinal products sourced from Northern Ireland to Great Britain for wholesale purposes are permitted under the supervision of a Responsible Person (RP) and will not require an RPi.

Conclusion

Manufacturers who wish to supply the UK market should be aware of the timelines set out in the MHRA’s Guidance and the actions that are required for continuing to place medicinal products on the UK market from 1 January 2021. While a number of obligations for manufacturers will not take effect for quite some time, there are also a number of new obligations that need to be fulfilled within the next few months. Manufacturers should also be aware of the differing treatment for products placed on the market in Northern Ireland compared with the rest of the UK. The situation may change from now until 1 January 2021 and stakeholders should keep informed of developments and keep matters under careful review.

[1] This is the information which is specified in paragraph 9(3)(a) of new Schedule 33A to the Human Medicines Regulations 2012, as inserted by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019).

The content of this article is provided for information purposes only and does not constitute legal or other advice.