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How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
How a marketing authorisation holder should report a defect with a veterinary medicine.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
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.
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
How to apply for simultaneous review of veterinary medicine submissions to the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the VMD.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Steps to help grow your business - finding finance, mentors, increasing sales and developing products and services
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance for manufacturers, importers and distributors.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Use form ALVS1 if the Automatic Licence Verification System cannot process an automatic release on CHIEF or the Customs Declaration Service.
Don’t include personal or financial information like your National Insurance number or credit card details.
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