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Detailed guidance, regulations and rules
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Consultations and strategy
Data, Freedom of Information releases and corporate reports
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information about ensuring blood and blood component safety.
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Information about the MHRA's Graduate Scheme and how to apply.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
Links to EU guidance, as it stood immediately before end of transition period.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Information about suspected side effects of e-cigarettes and how to report side effects.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access p…
Guidance on whether or not your product is a medical device.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Guidelines to help mitigate and manage medicine shortages.
To share a common understanding of the objectives and the operations of the Access Consortium - Generic Medicines Working Group (GMWG).
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