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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.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
List of administrations whose Certificate of Competency (CoC) are accepted towards issuing a UK Flag State Endorsement (FSE)
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Guide to licensing requirements and restrictions for trade control and the export of controlled military goods, software and technology.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
Information to help you protect, manage and enforce your intellectual property (IP) rights in China.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to apply for marketing authorisation via this new procedure.
Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
Information for businesses on the regulatory framework and transitional arrangements January 2023.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
British Medical Association trade union: annual returns, rules, statement to members, decisions and other related documents.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Information on how to revalidate a UK CoC (and UK GMDSS at the same time).
FDA trade union: trade union: annual returns, rules, statement to members, decisions and other related documents.
The Certification Officer (CO) and her team ensure that trade unions and employers’ associations carry out their statutory duties. Certification Officer works with the Department for Business and Trade .
Certification Officer (CO) decisions made in response to complaints and applications.
Find a list of codes for the types of Government Department licences that can be declared for imports and exports in Data Element 2/3 (Appendix 5C).
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