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Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
What you need to know about and do to comply with the law and keep consumers safe.
Guidance for manufacturers, importers and distributors on the Product Security and Telecommunications Infrastructure Act 2022 and Regulations 2023.
The way you apply to licence biological products has changed
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
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.
How to use feedback from marketplace reviews to evaluate your digital health product.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Submission dates and how the submissions using the EC decision reliance procedure work.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
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.
Apply to manufacture Extemporaneous preparations, Autogenous vaccines, authorisations for Equine Stem Cell Centre (ESCCA) or Non-Food Animal Blood Bank (NFABBA).
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
The Department for Business and Trade has announced the 10 SME winners of the 2024 Made in the UK, Sold to the World Awards.
Guidance on choosing evaluation study types and methods.
Guidance for manufacturers, their authorised representatives and importers.
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