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This guidance summarises our approach to pharmacovigilance
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
Submission dates and how the submissions using the EC decision reliance procedure work.
How to change the ownership from one marketing authorisation (MA) holder to another.
Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.
How to prepare for implementation and compliance of the Safety Features Regulation.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Advice on writing clear notices and maximising replies to your FSNs.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Importing investigational medicinal products for use in clinical trials
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Register as a manufacturer, importer or distributor of active substances.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Comply with good pharmacovigilance practice and prepare for an inspection.
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