New MHRA Guidance following a ‘hard’ Brexit

On January 3rd the MHRA issued its updated guidance on the regulation of medicines, medical devices and clinical trials in the event of a no-deal Brexit. 
In this scenario the MHRA would regain sole responsibility for all regulatory activities currently carried out by the EMA in the UK. The updated guidance can be found here.

The goals:

  • Providing seamless legal cover for all procedures currently governed by EU law
  • Improving the existing regulatory framework
  • Maintaining a competitive Life Sciences and Healthcare Industry in the UK

The Guidance:

  1. New Options for Securing a Marketing Authorisation (MA)
  2. Packaging, Leaflets and Consequences for Implementation of the EU Falsified Medicines Directive
  3. Batch Certification of Medicinal Products derived from Human Blood or Plasma
  4. Paediatric Investigation Plans (PIP), Orphan Designations (OD) and Scientific Advice
  5. Handling of Prescriptions from EU Countries

1. New Options for Securing a Marketing Authorisation (MA)

  • A ‘Rolling Review’ process for novel active substances and biosimilars, in which applications and assessments are carried out in stages throughout development.
  • ‘Targeted Assessments’ guaranteed to finish within 67 for new applications submitted via the CAP with positive CHMP opinion; this mirrors the timeline from CHMP opinion to EC decision, ensuring that new medicines can be launched on identical dates in all markets.
  • Option to ‘Fast-track’ the national licensing procedure for new active substances to a 150-day accelerated assessment.
  • ‘Grandfathering’ of existing Centrally Authorised MAs with automatic conversion to a UK MA on 29 March 2019
  • UK converted CAPs to be legitimate references on which abridged applications for generics or biosimilars can be based upon

2. Packaging, Leaflets and Consequences for Implementation of the EU Falsified Medicines Directive

Amendments to national law require that the Package Leaflet contains:

  • UK Product License number
  • Name and address of the UK MAH
  • Most recent information about the manufacturing site 

For products marketed prior to Brexit, these changes need to be completed by the end of 2021.

Implementation of FMD requirements:

  • A no-deal Brexit will terminate access to the EU central data hub meaning that no information on the location history of medicinal product packs can be exchanged
  • Exclusion from this verification system will leave UK supply chains more vulnerable to influx of falsified medicines 
  • To address this public safety concern, the MHRA is currently assessing options for development of a future national Falsified Medicines Regulatory Framework. 

3. Batch Certification of Medicinal Products derived from Human Blood or Plasma

  • Currently, medicines derived from biological materials must be independently tested by an Official Medicines Control Laboratory (OMCL) before marketing; OMCL membership comes with mutual recognition of batch certification and release. 
  • The MHRA is actively trying to find an alternative for the UK National Control Laboratory’s (NIBSC) OMCL membership after a hard Brexit.
  • Israel and Switzerland are expected to sign an MRA with the UK termed OCABR (Official Control Authority Batch Release), and other countries are also invited to sign up.
  • The NIBSC will review batches coming into the UK:
    • All EU member states will be listed as ‘Approved Countries’
    • Batch testing carried out by their National Laboratories is likely to be accepted 
    • Charges will apply

4. Paediatric Investigation Plans (PIP), Orphan Designations (OD) and Scientific Advice

  • MHRA procedures for PIPs and ODs will be essentially the same as the current EU system. 
  • Fees for MAA for ODDs will be completely refunded to SMEs. 
  • All scientific advice fees will be waived for UK based SMEs.

5. Handling of Prescriptions from EU Countries

  • All EU member states will be listed as ‘Approved Countries’, with no major changes in handling of prescriptions planned. 
  • Prescriptions will be handled as ‘Private Prescriptions’ and will not be covered by the NHS.