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You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidelines to help mitigate and manage medicine shortages.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
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.
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 continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
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.
Guidance on what approved bodies are, what they do and how you can become one.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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