What are the requirements relating to the qualifications and registration of signatories?
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.
The supplementary information to Clause 8.1 sets out the qualifications of signatories, it 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.
The registered medical practitioner should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge. Details of signatories and their qualifications have to be provided to the Medicines Healthcare products Regulatory Agency (MHRA), as well as the PMCPA.