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How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Find out the rules to establish the country of origin of imported and exported goods and to help identify goods which qualify for lower or no Customs Duty.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Get help to classify electrical equipment such as communication equipment, cameras, and their parts and accessories.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How to apply to protect a food, drink or agricultural product name under the UK GI schemes.
What you need to know about and do to comply with the law and keep consumers safe.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Find out what a composite food product is, and the rules you need to follow to export or move these products from Great Britain to the EU and Northern Ireland.
Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products.
How to use a quasi-experimental study to evaluate your digital health product.
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
Use these general provisions to help you determine the origin of your products.
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