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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Industry review identifying opportunities for development of financial products to help people pay for care.
Labelling rules for businesses in Great Britain (England, Scotland and Wales) and retailers in Northern Ireland, for certain agri-food products moved under the Northern Ireland Retail Movement Scheme.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
How to use a cost benefit analysis to evaluate your digital health product.
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.
Resources to help anyone developing or running a digital health product to conduct an evaluation.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
Things to consider when buying and using products.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to use a cost effectiveness analysis to evaluate your digital health product.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Information and guidance on a range of medical devices for users and patients.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
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