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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.
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 and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
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.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
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.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
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).
How to use a before-and-after study to evaluate your digital health product.
You must get permission to export certain drugs and medicines.
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.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to apply for simultaneous review of veterinary medicine submissions to the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the VMD.
Submission dates and how the submissions using the EC decision reliance procedure work.
Steps to help grow your business - finding finance, mentors, increasing sales and developing products and services
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