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How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
How to create a model of how your digital health product works and choose measures for your evaluation.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Steps to help grow your business - finding finance, mentors, increasing sales and developing products and services
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
These published standards relate to a number of KPIs in the VMD Deliverables and KPI document.
Details about the Registration, Evaluation and Authorisation of Chemicals (REACH) defence exemption process within the MOD.
How to use a cost utility analysis to evaluate your digital health product.
Guidance on choosing evaluation study types and methods.
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.
Use these general provisions to help you determine the origin of your products.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Ensuring you get what you pay for.
Don’t include personal or financial information like your National Insurance number or credit card details.
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