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Application for a licence to trade in precursor chemicals category 2 substances
Get relief if you’re importing biological and chemical substances for research purposes from outside the EU and UK.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Explains planning controls relating to the storage of hazardous substances in England and how to handle development proposals around hazardous establishments.
Licence and registration application information for companies that deal in precursor chemicals.
Register as a manufacturer, importer or distributor of active substances for use in veterinary medicines.
Register as a manufacturer, importer or distributor of active substances.
Substances that are classed as persistent organic pollutants (POPs) and when you're allowed to use them.
How to apply for an exemption to use a restricted substance to manufacture electrical and electronic equipment.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
Guidance on the European Union regulation on explosives precursors, including licensing, labelling and reporting suspicious activity
How and when you can apply for quota to sell ozone-depleting substances (ODS) to import or produce in Great Britain.
You must have a licence to import or export ozone-depleting substances (ODS) to and from Great Britain (England, Scotland and Wales).
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
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