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How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Use the case studies to help you decide when your goods may (or may not) go beyond insufficient production.
How product specific rules are used to identify the country of origin when importing or exporting between the UK and EU.
Find out how to make fertiliser from processed ABPs including bonemeal, and if you need approval to manufacture, store or transport it.
Guidance on a strategy for genotoxicity testing and mutagenic hazard assessment of impurities in chemical substances.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Findings from a Focus on Enforcement review in the chemicals industry relating to the Control of Major Accident Hazards (COMAH).
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Appropriate measures for waste treatment.
A guide to farming risks, potential problems with public safety and how to avoid accidents
Explains planning controls relating to the storage of hazardous substances in England and how to handle development proposals around hazardous establishments.
Get help to classify ceramic articles for import and export.
Check what classifies as plastic, recycled plastic and packaging components, and if the packaging you manufacture or import is subject to the tax.
Check the VAT rules for food processing and abattoir services.
Paper and cardboard production can cause significant pollution. This guide describes industry responsibilities for preventing pollution.
Five guidance statements on testing chemicals with no or inadequate genotoxicity data.
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