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Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
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.
Find out how to apply VAT to charges for postage, delivery services and how to treat direct marketing services involving distribution of printed matter.
How to market forest reproductive material (FRM) for forestry purposes, including regulations, registration, master certificates and licences.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Use this form if you represent a local authority applying to revoke a mobile home site licence where the occupier of the land is in contravention of regulation 4(1) of the Mobile Homes Regulation 2020 (requirement for manager of site...
If you’re a public sector body or a housing association, you can use the Dynamic Purchasing System (DPS) to procure housebuilders to build homes on your land.
How developers can create and enhance habitat off-site or buy biodiversity units to achieve biodiversity net gain (BNG).
Pharmacovigilance system requirements
You must get permission to export certain drugs and medicines.
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to renew marketing authorisations for products granted through different routes and at different times.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Marking, labelling and marketing standards you must follow to import and export plant seeds, food and manufactured goods.
How to apply for marketing authorisation via this new procedure.
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