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Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Explains planning controls relating to the storage of hazardous substances in England and how to handle development proposals around hazardous establishments.
Licences and regulations for organisations that handle human blood or blood products and reporting adverse incidents with blood through SABRE.
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.
This guide sets out who has to apply for a permit, how to apply and explains the other rules covering travel to Antarctica.
Information about the EU Regulations and their implementation in Northern Ireland
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
How to renew marketing authorisations for products granted through different routes and at different times.
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.
Check if you can apply for Authorised Use relief to reduce your payments when you import goods for a specific use. This can include repairs, maintenance or processing.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to request and manage the authentication code you'll need to file information online at Companies House.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
This part of Schedule A1 is about changes to the bargaining unit or where the bargaining unit has ceased to exist
Guidance on prescribing or supplying veterinary medicines including requirements for registration and inspection of premises.
This guidance tells HM Passport Office staff when to ask for extra authorisation from another person or organisation before we issue a passport.
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.
Authorisation decisions on the time-limited use of hazardous substances of very high concern under UK REACH.
Getting a UK background check so you can apply for Global Entry and get through USA border control faster: how to apply, how much it costs
How to get fast-track approval of medical devices during COVID-19.
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