Government Issues Brexit Technical Notice for Life Sciences

International

On 23 August 2018, the UK Government (the "Government") issued the first wave of its technical papers designed to provide guidance to companies to help prepare for a "No Deal" Brexit. In this scenario, there will be no "transition period" but rather the UK will simply become a third country to the European Union ("EU") from 29 March 2019. The full guidance paper for human medicines regulation can be found here, and a summary of its key provisions below. In addition, there are other relevant notices on batch testing, found here, and on submitting regulatory information on medicinal products, which can be found here. From the guidance, it is clear that the Government's intention is to maintain regulatory alignment with the EU. The Medicines and Healthcare products Regulatory Agency ("MHRA") will be undertaking a consultation in the autumn, so a more comprehensive technical notice is expected to be issued after that.

1. Medicines

Issue

Government Guidance in the event of a "No Deal" Brexit

Marketing Authorisations ("MA")

The Government states that all EU centrally authorised product MAs will automatically be converted into UK MAs on 29 March 2019.

As the UK will no longer be a part of the EU centralised, mutual recognition and decentralised procedures, an initial MA application will need to be submitted to the MHRA and will go through a national assessment to market a product in the UK.

Medicines licensed via the EU mutual recognition or decentralised procedure prior to 29 March 2019 will be unaffected as they already hold a national UK MA.

For centralised procedures in progress at the time of exit, the application as submitted to the European Medicines Agency ("EMA") will need to be submitted to the MHRA. If the Committee of Medicinal Products for Human Use ("CHMP") has issued an opinion by exit day, the MHRA will take that into account; otherwise the MHRA will continue to assess the application as a national procedure.

The Government proposes a transitional provision for mutual recognition and decentralised procedures in progress immediately before exit day. The transitional process will depend how far the procedure has got but if successful, it will be approved as a national MA.

The start of data or market exclusivity will be the date of authorisation in the EU or UK, whichever is earlier.

New generic MA applications would need to be based on reference products that have been authorised in the UK. Existing MAs for generic products which are based on a reference product authorised in the EU would remain valid.

Legal Presence requirements

The MHRA's current requirement for a named individual to be contacted in the event of a safety issue with the power to require re-testing of medicines and to withdraw products will continue. However, the requirement would include the following:

  • the MA holder ("MAH") be established in the UK by the end of 2020;
  • the Qualified Person for Pharmacovigilance be established in the UK on 29 March 2019, although those companies without a current UK presence will have until the end of 2020 at the latest to do so; and
  • a Qualified Person ("QP") for products manufactured in the UK or directly imported into the UK from outside a country on the designated country list (whitelist) must reside and operate in the UK.

Paediatric Medicines

The Government will make provisions for a UK Paediatric Investigation Plan including the deferral and/or waiver of the need for studies where appropriate.

Orphan Medicines

The Government will be consulting on the proposed UK approach to the regulation of orphan medicines post-Brexit.

 

Packaging and Leaflets

The MHRA would continue to accept proposals for packaging and leaflets in the English language that include information from other jurisdictions, as long as such information complies with UK requirements.

Pharmacovigilance

 

The MHRA will have primary responsibility for the conduct and oversight of all pharmacovigilance activities in relation to UK MAs, certificates of registration and traditional herbal registrations.

Online Sellers

 

UK online sellers will no longer be required to display the EU common logo. The Government proposes exploring the use of a new "UK logo" for UK-based online sellers from 2021.

Good X Practice (GxP) Guidelines

The Government proposes to continue using the EU Good Manufacturing Practice and Good Distribution Practice guidelines.

Parallel Distribution and Parallel Imports

 

The UK will unilaterally align to the EU/EEA exhaustion regime to provide continuity for businesses and consumers to ensure that parallel imports of goods, such as pharmaceuticals, can continue from the EU/EEA.

2. Devices

Issue

Government Guidance in the event of a "No Deal" Brexit

Medical devices on the UK market

 

For a limited period, the UK would continue to recognise that the CE mark on medical devices and devices are accepted on the UK market if they meet all EU requirements.

Notified Bodies

 

UK based Notified Bodies would no longer be able to assess the conformity of medical devices to receive the CE mark and enter the EU market.

Post market surveillance of devices

 

The MHRA would continue to perform national post-market surveillance of medical devices on the UK market and be able to take a national decision over the marketing of a device in the UK.

3. Clinical trials

Issue

Government Guidance in the event of a "No Deal" Brexit

Clinical Trial applications

 

UK clinical trial applications will continue to be authorised by the MHRA and ethics committee, and the UK's ability to participate in multinational trials will also not change.

Legal Presence

While the legal representative will only need to be based in the EU or EEA, the Government is likely to require that an individual is based in the UK who has overall responsibility for the trial.