Regulatory Resources

OTC Medicines


PAGB members can access detailed regulatory intelligence on OTC medicines (below), self care medical devices and food supplements when logged in to this website (registration for PAGB members and associate members only).  This information is automatically emailed on a weekly basis to PAGB members who subscribe to our Regulatory Intelligence newsletter. Contact for more information about subscribing to this newsletter.

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About OTC medicines regulation

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To be granted a Marketing Authorisation (MA) or a traditional herbal registration (THR), the applicant company has to provide sufficient evidence to prove to MHRA that the product meets all the necessary requirements. Products may also be granted a MA through a European route which can allow a medicine to be launched into more than one Member State.



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