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Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulation relating to Pharmacovigilance.
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.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Check the tariff classification for flavour pods.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
The actions to take for sourcing medicines in different circumstances.
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Information on carrying medicine containing controlled drugs for individual travellers entering or leaving the UK.
Check the tariff classification for articles made of cermet.
How to use A/B testing to evaluate your digital health product.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
Examples of how and when to adjust the customs value for commercial level and quantity when using Methods 2 or 3 if you’re an importer or clearing agent.
Use an OGEL to export controlled dual-use or military goods, software and technology overseas.
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
How to apply for an exemption to use a restricted substance to manufacture electrical and electronic equipment.
Guidance for industry on flexible approaches we are taking on good distribution practices.
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