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Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Apply for an Academic Technology Approval Scheme (ATAS) certificate, to study certain subjects in the UK.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Application form K3 for registration of a Pending Action
Extradition processes and agreements between the UK and other countries, role of the Secretary of State, High Court and Supreme Court.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to change the ownership from one marketing authorisation (MA) holder to another.
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
From 13 May 2024 we are introducing a change to the procedure for new Marketing Authorisation (MA) applications, where a joint assessment of labels is requested.
Find out about the different simplified declarations for imports and what you need to do to get authorisation to use them.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
What documents clients need to submit to manage building control approval for higher-risk building work under transitional arrangements.
Follow this guidance to submit information to the Cabinet Office on all consultancy and professional services spend at or above the thresholds specified below.
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Licence and registration application information for companies that deal in precursor chemicals.
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