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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.
The way you apply to licence biological products has changed
Use this form to notify the IPO of marketing authorisation for a medicinal or plant protection product, granted after your application for an SPC for that product.
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.
Guidance for the pharmaceutical industry on applying for a marketing authorisation for parallel import (MAPI).
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How marketing authorisation holders should provide educational materials to MHRA for assessment and approval prior to launching their products on the UK market.
The seeds which must be certified before you can market them, how to get them certified and how to get a licence for your seed business.
How to change the ownership from one marketing authorisation (MA) holder to another.
Marketing authorisations granted in 2024
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Protect your brand by registering it as a trade mark - how to apply, fees, responding to objections to your trade mark, using the ® symbol
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
The Veterinary Medicines Directorate may suspend or expire a licence to market an animal medicine if it fails to comply with the regulations.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Marketing authorisations (MAs) granted since January 2014.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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