MHRA EU Exit no-deal contingency legislation for the regulation of medicines and medical devices

Closes 1 Nov 2018

Introduction

MHRA CONSULTATION ON EU EXIT NO-DEAL PROPOSALS

EU Exit

The UK is exiting the EU on 29th March 2019. The UK and EU negotiating teams have reached agreement on the terms of an implementation period that will start on 30 March 2019 and last until 31 December 2020. With talks ongoing, we remain firmly on track to reach agreement on the Withdrawal Agreement and Future Framework in the Autumn.

However, a responsible government should prepare for all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached and that is exactly what we are doing, with this consultation forming part of these preparations.

Overview

This consultation seeks your views on how the Medicines and Healthcare products Regulatory Agency’s (MHRA) legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period.  This consultation covers no-deal proposals on medicines, clinical trials and medical devices.  Following on from the publication of the technical notices, on 23 August 2018, in relation to How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal, Batch testing medicines if there's no Brexit deal, and Submitting regulatory information on medical products if there’s no Brexit deal, this consultation also asks questions on the finer detail of how that policy might be best implemented in the event of no deal being reached.

The overall approach in no-deal is for the Secretary of State for Health and Social Care and the Minister for Health, Social Services and Public Safety in Northern Ireland, acting through the MHRA, to be a stand-alone regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.  This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.

Our approach

This consultation covers changes to four different Statutory Instruments (SIs): the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016.  The changes to the latter two instruments are combined in a single SI.

Many of the changes to these SIs are of a technical nature which will remove relevant references to the EU, insert references to the UK and other similar changes. The legislation is still being drafted and we are not consulting on the exact legal texts. Rather, this consultation gives narrative on any amendments being considered, with the following principles having been applied:

  • pragmatic and proportionate approach in establishing UK regulatory requirements.
  • the UK regulator’s ability to take regulatory action to protect public safety.
  • minimum disruption and burden on companies as the UK exits the EU.
    In line with this approach, we are also publishing the draft legal texts that relate to the amendments being consulted on in this document.
    A small number of legislative changes have been communicated in August 2018 in the Government’s no deal Technical Notices, to ensure that stakeholders have as much time as possible to prepare

 

Policy changes with the biggest impact on which views are sought

Consultation information

  • The consultation will run for 4 weeks and close at 23:45 on 1st November 2018.  You will be asked a series of questions and are required to input your responses either by clicking the corresponding button or by typing in responses where this is appropriate.
  • The policy issues we are seeking your views on are listed below and more information about every issue, background and questions are in the main consultation question pages and the Consultation Annex.

Contents of consultation (please note each section is optional depending on what areas you are interested in responding)

SECTION 1 MEDICINES   

  • Change M1: Legal presence
  • Change M2: New marketing authorisation (MA) assessment routes
  • Change M3: Converting centrally authorised products (CAPs) to UK MAs (grandfathering)
  • Change M4: Packaging

 A: Amending packaging and leaflets for a product on the market

 B: Safety Features under the Falsified Medicines Directive (FMD)

  • Change M5: Paediatric investigation plans (PIPs) and studies
  • Change M6: Orphan designation
  • Change M7: Abridged applications
  • Change M8: Increased requirements for needing a manufacturer’s licence for import or a wholesale dealer’s licence
  • Change M9: Recognition of prescriptions
  • Medicines Impact Assessment

SECTION 2 CLINICAL TRIALS        

  • Change CT1: Legal presence – clinical trials
  • Change CT2: Transparency
  • Change CT3: Use of designated country lists, including for legal presence and importation of investigational medicinal products
  • Clinical trials Impact Assessment

SECTION 3 MEDICAL DEVICES    

  • Change D1: Registration of medical devices
  • Devices Impact Assessment

SECTION 4 FEES

  • Change F1: Fee waivers for orphan products
  • Change F2: New/amended MHRA fees for six processes/services previously provided centrally by EC/EMA
  • Fees Impact Assessment

SECTION 5 NIBSC            

  • Change N1:  Independent UK batch testing of biological medicines and associated fees
  • NIBSC Impact Assessment

SECTION 6 IMPACT ASSESSMENT       

  • Further comments to support the Impact Assessment

SECTION 7 PUBLIC SECTOR EQUALITY DUTY         

  • Impacts (positive or negative) of these proposals on groups with protected characteristics for the purposes of the Equality Act 2010 or on other groups of people who suffer health inequalities