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A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
Information and guidance on a range of medical devices for users and patients.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Detailed guidance on advertising and promoting medicines.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
How to make a payment to MHRA by credit or debit card or a bank transfer.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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.
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