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Data, Freedom of Information releases and corporate reports
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Information for clinicians and patients.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Comply with good pharmacovigilance practice and prepare for an inspection.
How to renew marketing authorisations for products granted through different routes and at different times.
How to apply for marketing authorisation via this new procedure.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Links to EU guidance, as it stood immediately before end of transition period.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
This Statutory Instrument makes the necessary legislative amendments to update the statute book by removing references to the revoked Annex VIII of GB Classification, Labelling and Packaging of Substances and Mixtures Regula…
Information relating to parallel imports and the implementation of the Windsor Framework.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
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