Updated: Added statements on Future regulatory partnership & EMA/EU & CMDh notices to Marketing Authorisation Holders.
Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.
While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.Medicines regulation
Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.Devices regulation
Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.Vigilance and market surveillance
We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.
MHRA will be engaging widely with our stakeholders to fully understand and maximise the opportunities of Brexit.Future regulatory partnership
On 4 July the UK Government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The statement, published in the Financial Times, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.EMA/EU & CMDh notices to Marketing Authorisation Holders
In regards the recent notices to Marketing Authorisation Holders issued by the EMA/EU-27 and CMDh advising of preparations MA holders may want to consider ahead of the UK’s exit from the EU.
Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. We therefore continue to play a full role in the network and to undertake our work as a Reference Member State (RMS) in the decentralised procedure, and as (co-) rapporteur in the centralised procedure. If, however you do want to consider preparation for any potential changes to marketing authorisation or RMS, please see the information provided by the EMA and the HMA.
Whatever the outcome of the negotiation we will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection.
Statements are also available from the British Pharmacopoeia and the National Institute for Biological Standards and Controls (NIBSC)
Customers, partners and stakeholders approaching MHRA continue to have access to our internationally recognised expertise and we maintain the highest quality services. For further information, please get in touch with your usual contact points in the Agency.seen at 10:30, 17 July in Announcements on GOV.UK.
Email this to a friend.