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Submissions related to human medicines need to be submitted directly to the MHRA.
How the MHRA processes variations to Marketing Authorisations (MAs)
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to renew marketing authorisations for products granted through different routes and at different times.
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
Business plans - download free templates and get help writing a business plan
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Steps to help grow your business - finding finance, mentors, increasing sales and developing products and services
Data protection rules for businesses in recruiting staff, keeping staff records and using CCTV
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How to market eggs, including rules on registration, egg marking, salmonella control and egg marketing inspections in England and Wales.
Pharmacovigilance system requirements
Form for a business to register seed marketing operations.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
How to contact MHRA for specific services or enquiries.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
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