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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Guidance for businesses and organisations on the relationship between trade marks and geographical indications (GIs) at the end of the transition period.
Guidelines on the acceptance of pleas and the prosecutor's role in the sentencing exercise (revised 2009).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
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