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Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
You must get permission to export certain drugs and medicines.
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)’
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.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Register as a manufacturer, importer or distributor of active substances.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
The actions to take for sourcing medicines in different circumstances.
Apply for and maintain registrations for the brokering of human medicines.
Importing investigational medicinal products for use in clinical trials
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Information relating to parallel imports and the implementation of the Windsor Framework.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Guidance on what approved bodies are, what they do and how you can become one.
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