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Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
The Marine Management Organisation (MMO) is preparing to help our fishing and seafood industries to be ready to trade successfully in the international marketplace from 1st January 2021.
How to submit an application, data package and company responses for proposed or existing authorisations in the UK.
Submission of notifications for northern Ireland under article 20 of directive 2014/40/EU.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
You should follow the standard file process outlined below when submitting work for online and paper billing.
Use this form to submit an article to feature in a future edition of the serious and organised crime (SOC) local partnerships bulletin.
Submission dates and how the submissions using the EC decision reliance procedure work.
Pharmacovigilance system requirements
Supports effective delivery of planning application process.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Applicants must obtain a submission slot in advance of submitting selected National Pharmaceutical MA applications.
5 quick tips on submitiing your paper for review
What operators need to do in terms of submitting plans for radioactive waste disposal following our exit from Euratom and requirements under Article 37.
Submissions related to human medicines need to be submitted directly to the MHRA.
Find out about sending a Stamp Duty Land Tax (SDLT) return, late filing penalties, amending a return and applying for a refund.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Don’t include personal or financial information like your National Insurance number or credit card details.
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