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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 (P), 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.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
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.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to register as a manufacturer, importer or distributor of active substances.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Apply for and maintain registrations for the brokering of human medicines.
Approved countries for batch testing and importation of medicines
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
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