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Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How the MHRA processes variations to Marketing Authorisations (MAs)
Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Keep up to date with the latest information from the UK GLP monitoring authority.
Pharmacovigilance system requirements
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Detailed guidance on advertising and promoting medicines.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to use the procedure for medicines licensing applications.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Fees payable to the MHRA for 2023 to 2024
How to prepare for implementation and compliance of the Safety Features Regulation.
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
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