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Form to register an egg production establishment.
You must get permission to export certain drugs and medicines.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Submissions related to human medicines need to be submitted directly to the MHRA.
How to submit an application, data package and responses for proposed or existing marketing authorisations.
How to change the ownership from one marketing authorisation (MA) holder to another.
How veterinary medicines can be advertised.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Data protection rules for businesses in recruiting staff, keeping staff records and using CCTV
Marketing authorisations (MAs) granted since January 2014.
Marketing authorisations granted in 2024
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Intellectual property can be bought, sold or licensed.
Guidance for suppliers and dealers.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Don’t include personal or financial information like your National Insurance number or credit card details.
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