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UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
Guidance on the deadlines for initial and response submissions.
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
How to join the phase I accreditation scheme.
How to change the ownership from one marketing authorisation (MA) holder to another.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Guidance for healthcare professionals on risk minimisation options for medicines.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information about ensuring blood and blood component safety.
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