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Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
Industry must notify the MHRA if they will not be using these flexibilities
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) laboratory inspection reports.
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
Our Patient Involvement Strategy sets out how we will engage and involve the public and patients at every step of the regulatory journey.
The MHRA's initial plans on an Early Access service, which will be developed further throughout 2025.
Report on the public health impact of nurses and midwives, dentists, allied health professionals and pharmacists.
Guidance for manufacturers who source their own-branded products from another company.
Due diligence for suppliers of e-cigarettes and e-liquids.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
VDEC’s Discovery and surveillance capabilities provide unique services across a spectrum of molecular immunology platforms.
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
Information for patients, public and healthcare professionals
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