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How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Keep up to date with the latest information from the UK GLP monitoring authority.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
How to write clear and effective field safety notices (FSNs) for medical devices.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
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