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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.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How a marketing authorisation holder should report a defect with a veterinary medicine.
Using an ecological momentary assessment to evaluate your digital health product.
Compare different evaluation approaches and choose an appropriate method.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
We advance prosperity by ensuring no viable UK export fails for lack of finance or insurance, doing that sustainably and at no net cost to the taxpayer.
An overview of the work the IPO is undertaking in relation to Standard Essential Patents.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
What you need to know about and do to comply with the law and keep consumers safe.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How to get your road safety product accredited by the Driver and Vehicle Standards Agency (DVSA), how much it costs, eligibility, and how to apply.
How to use feedback from marketplace reviews to evaluate your digital health product.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
Guidance on choosing evaluation study types and methods.
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