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Submission dates and how the submissions using the EC decision reliance procedure work.
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.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
This collection brings together all of the available resources to be used in promoting T Levels
Guidance for UK businesses on rules for selling services to Denmark.
When a business changes owner, employees could be protected under the Transfer of Undertakings (Protection of Employment) regulations (TUPE) - types of transfers, your rights, contracts, redundancy, where to get help
How the Northern Ireland Protocol affects supplementary protection certificates (SPCs), and what it means you need to do when applying for an SPC and afterwards.
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.
Find out about changes to the Business Investment Relief rules from 6 April 2017.
Marketing company Mania has been designated under the UK’s Bosnia and Herzegovina sanctions regime.
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