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How to submit an application, data package and company responses for proposed or existing authorisations in the UK.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Pharmacovigilance system requirements
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Supports effective delivery of planning application process.
The controls that apply if you transport waste out of or into England.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products.
Learn how to publish accessible documents to meet the needs of all users under the accessibility regulations.
Find out how to prove the originating status of your goods and check if you can claim preferential tariff treatment.
Sets out the process for efficient and inclusive consultation of planning applications
How to write requirements for services on the Digital Outcomes and Specialists framework
This paper outlines the methodology used for the 2012 GHG Conversion Factors. These have been superseded by the 2013 factors, integrated into a web based tool.
Submissions related to human medicines need to be submitted directly to the MHRA.
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