Clause 16 - Training
16.1 All relevant personnel including representatives and members of staff (including persons retained by way of contract with third parties) concerned in any way with the preparation or approval of promotional material or of information to be provided to members of the UK health professions and to appropriate administrative staff or of information to be provided to the public and recognised patient organisations must be fully conversant with the requirements of the Code and the relevant laws and regulations.
The materials/activities covered by the Code include promotional materials and activities listed in Clause 1.1, information provided to health professionals and other relevant decision makers and information provided to the public, patients and patient organisations.
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.
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 examination must have been accredited to at least Level 3 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 a Diploma (at least 37 credits or equivalent learning hours).
An appropriate examination for generic sales representatives is one that requires a broad understanding of body systems, the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be a Certificate (at least 13 credits or equivalent learning hours).
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 as the ABPI examinations and covering similar content and learning material as the corresponding ABPI examination.
- Supplementary information
- Cases
- Advice
- Clause 16.3 Examinations
- Clause 16.3 Accredited Examinations
- Clause 16.3 Information from Examination Provider
- Clause 16.3 Time Allowed to Pass an Examination
MOST RECENT CASES See all Applicable Code year
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 Prescription Medicines Code of Practice Authority on request.
