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This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Approved countries for batch testing and importation of medicines
How to apply for marketing authorisation via this new procedure.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
The actions to take for sourcing medicines in different circumstances.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Guidance for business and government departments.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How to conform with the legal requirements for placing medical devices on the market.
Importing investigational medicinal products for use in clinical trials
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Definitive fees charged for applications under Schedule 7 of the Veterinary Medicines Regulations 2013.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How to apply for approval for a suitably qualified person (SQP) retailer premises to sell or supply animal medicines.
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