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

  • 14.1

    14.1 Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by one person on behalf of the company in the manner provided for by this clause, subject to the provisions of the supplementary information to this clause where relevant. This person 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 person certifying on behalf of the company must not be the person responsible for developing or drawing up the material.

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 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.

Details of signatories and their qualifications have to be provided to the Medicines Healthcare products Regulatory Agency (MHRA) which will therefore be aware of the qualifications of all signatories.

Guidance
2021 Q&As by Topic OR Clause