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The government's summary of an EU Commission proposal to amend EU legislation relating to medicinal products for human use and the impact on Northern Ireland.
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.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Helping public health practitioners conducting evaluations – developing a logic model to represent how your intervention works.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
Details of certificates issued under the Special Import System for the top ten imported veterinary medicines 1 April - 30 June 2023.
This report makes recommendations on whether to regulate practitioners of herbal medicine and the products they use to keep the public safe.
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
Apply for and maintain registrations for the brokering of human medicines.
Information about new applications, post-licensing, advertising, product information and fees.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without a marketing authorisation.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Actions that trial sponsors should consider to build resilience into clinical trial design
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