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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Business potential of producing crops for non-food markets, how and where to grow them and details of organisations providing grants.
Importing investigational medicinal products for use in clinical trials
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
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.
The actions to take for sourcing medicines in different circumstances.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Product Safety Report for Wau Wa Eczema Herbal Cream presenting a serious chemical risk.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
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