Clause 9

9.1

(16.1) All relevant personnel, including representatives, and members of staff, and others retained by way of contract, concerned in any way with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations.

9.2

(16.2) All personnel (and others retained by way of contract) must be fully conversant with pharmacovigilance requirements relevant to their work, and this must be documented.

9.3

(15.1) Representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines which they promote.

9.4

(16.3) Representatives must take an appropriate examination within their first year of employment as a representative and must pass it within two years of starting such employment. To be acceptable, an appropriate examination must have been accredited to at least Level 3 or its equivalent by an external awarding body recognised by Ofqual.

An appropriate examination for medical representatives is one that requires a broad understanding of body systems, diseases and treatments, the development of new medicines and the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be at the level of a Diploma (equivalent to at least 480 hours Total Qualification Time).

An appropriate examination for generic sales representatives is one that requires a broad understanding of body systems and the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be at the level of a Certificate (equivalent to at least 330 hours Total Qualification Time).

An appropriate examination can be either the relevant ABPI examination (for medical or generic sales representatives) or an examination of at least the same standard which covers similar content and learning material as the corresponding ABPI examination.

9.5

(16.4) Details of the numbers of representatives who have passed an examination, together with the examination status of others, must be provided to the PMCPA on request.