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Medical signatories

04/05/2016

What are the requirements relating to the qualifications and registration of medical signatories?

Medical signatories must be a registered medical practitioner or a pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a  UK registered dentist.  There are no requirements in the Code relating to the actual qualifications of medical signatories.  The advice usually given is that the proposed medical signatory should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge.
 
The supplementary information to Clause 14.1‚Äč states that when deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outwith the industry, length of service and seniority.  In addition, signatories must have an up-to-date, detailed knowledge of the Code.
 
Pharmacists acting as signatories must be registered in the UK.
 
Details of signatories and their qualifications have to be provided to the Medicines and Healthcare Products Regulatory Agency which will therefore be aware of the qualifications of all signatories.