UK Government Publishes No-Deal Brexit Advice
The UK government released today their first series of advice documents to inform stakeholders of the implications in the event of a No-Deal Brexit scenario.
Several of these documents consider the implications for the regulation and supply of medicines and we provide a summary of key points below.
Links to each document from the UK Government can be found by clicking the subject titles.
How medicines would be regulated if there’s no Brexit deal
There are several procedures that a Marketing Authorisation can be obtained through currently: Centrally Authorised, Decentrally Authorised, through Mutual Recognition and nationally.
The implications of a no Brexit deal are laid out as follows:
Converting centrally authorised products (CAP) to UK Marketing Authorisations
On 29th March 2019 all CAP MAs will automatically be converted into UK MAs.
MAHs will have a period of time from exit day to provide MHRA with baseline data for CAPs that are converted into UK MAs, the exact requirements to be communicated at a later date.
This is likely to cause workflow issues for MAHs and Diamond can provide overflow support to meet the needs of converting these authorisations.
Initial Marketing Authorisation applications
An initial MA application will need to be submitted to the MHRA and will go through a national assessment. The UK will no longer be a part of the EU centralised, mutual recognition and decentralised procedures.
Diamond carry out National submissions with MHRA already, and therefore we will be able to provide continuing services to meet the needs for new applications in a No-Deal scenario.
Medicines licensed via Mutual Recognition and Decentralised Procedures
Existing medicines that received a MA for the UK via the MR or DC routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA.
- In-progress licensing procedures at time of exit
Any EU procedures that have not reached the decision phase at the time that the UK exits the EU will not be valid in the UK.
For centralised procedures in progress at time of EU exit the application will need to be submitted to the MHRA.
It is proposed that a transitional provision will be made for MRP and DCP procedures in progress immediately before Exit day. MHRA will complete the assessment (the transitional process for this will depend on how far the procedure has got immediately before Exit day) but if successful, they will be approved as a national (UK) MA.
‘Generic’ MAs – reference products: The MHRA will not have access to the data provided in support of EU approved products. Therefore, new generic applications would need to be based on reference products that have been authorised in the UK.
Diamond will be able to help MAHs with any resubmissions that are required.
Submitting regulatory information on medical products if there’s no Brexit deal
This notice provides the UK Government’s position on how regulatory information will be practically submitted to MHRA, particularly for processes currently managed by shared EU wide systems (e.g. CESP, EMA gateway, Eudravigilance, Common repository, PSUR repository, PedRA, EudraCT and new CTR portal, Article 57 database, Eudralink and EudraMail).
The government confirm that the UK would need its own national portals for:
- marketing authorisation (MA) applications
- periodic safety update reports (PSURs)
- paediatric investigation plans (PIPs)
- clinical trial applications
- qualified person for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) notifications
- individual case safety reports (ICSRs) and subsequent transmission of anonymised single patient reports (ASPRs)
- device registration
- e-cigarette notifications.
The portal systems would adopt the following principles:
- Continue to accept EU application forms and EU standards for submissions where possible
- Accept eCTD submissions in relation to MAs
- Systems to be live by March 2019 but to be developed further over time
- Stakeholders would be asked to test the systems prior to March 2019 and further information will be provided at a later date.
Diamond will continue to monitor these new systems and be ready to help clients prepare to meet the needs of UK based submissions in the event of a Hard-Brexit, whilst simultaneously providing EU solutions.
Developing genetically modified organisms if there’s no Brexit deal
Regulatory decisions on proposed GMO trials will continue to be made within the UK as they are now on a devolved basis.
Ensuring blood and blood products are safe if there’s no Brexit deal
Blood establishments, blood banks and manufacturers of blood products
Blood and blood components from the UK:
- must conform to the current EU testing requirements (Directive 2002/98/EC4).
- must also meet with the equivalent standards (Directive 2004/33/EC5) of quality and safety as implemented by the UK Blood Safety and Quality Regulations 2005.
Import of blood or blood components into the UK from any country
- Each unit of blood and blood component imported must be prepared in accordance with standards equivalent to the EU standards (which have been transposed into UK law) and requirements set out in the Annex to Commission Directive 2005/62/EC and meet the standards of quality and safety equivalent to those we currently have implemented. These standards are also set out in Part 5 of the Blood Safety and Quality Regulations 2005.
Export of blood or blood components from the UK
- Each unit of blood and each blood component exported must conform with the EU testing requirements (Annex IV, Directive 2002/98/EC4) and meet the equivalent standards of quality and safety (Annex V to Directive 2004/33/EC5).
Manufacturers of blood products
You should comply with Directive 2002/98/EC for the collection and testing of human blood and human plasma, for use in manufacture of blood products.
Quality and safety of organs, tissues and cells if there’s no Brexit deal
The EU Organ Directives and EU Tissues and Cells Directives would no longer apply to the UK. UK law already implements the EU directives, so the safety standards would not change. The UK would, however, become a ‘third country’ and the law would be amended under the EU (Withdrawal) Act to reflect this change.
UK licensed establishments that import or export tissues or cells from EEA establishments would need to make written agreements with those EEA establishments to continue importing or exporting these products post-exit.
For example, UK licensed establishments that already hold an import licence to import tissues and cells from third countries will be able to use their existing written agreements with third country organisations as a template.
Tissues and cells from the UK would meet the current EU safety and quality standards.
Tissues and cells for human use, including reproductive cells
After exit day, the UK and EU countries would consider each other as third countries. The EU directives 2004/23/EC and 2015/566 allow for written agreements to be made to import and export tissues and cells for human use between EU countries and third countries, as set out in EU directive 2015/566. Licensed establishments that import or export tissues or cells would need written agreements with the relevant EU licensed establishments to continue importing and exporting. UK licensed establishments that already hold an import licence to import tissues and cells from third countries can use their existing written agreements with third country organisations as a template. Licensed establishments are recommended to consult the HTA and HFEA for more information.
Organs for transplantation
On 29 March 2019 the UK would meet the current EU safety and quality standards for organs, and these would be traceable from donor to recipient and from recipient to donor.
After exit day, the UK and EU countries would consider each other as third countries. The EU directive 2010/53/EU allows for organ exchange between EU countries and third countries. Organisations that currently exchange organs can make written arrangements to ensure organs can still move between the UK and EU countries.