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Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Information for clinicians and patients.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Apply for and maintain registrations for the brokering of human medicines.
Guidelines to help mitigate and manage medicine shortages.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Approved countries for batch testing and importation of medicines
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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.
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
This publication supports local authority health and wellbeing boards to develop and update pharmaceutical needs assessments (PNAs).
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