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.
16.2 All personnel (including persons retained by way of contract with third parties) must be fully conversant with pharmacovigilance requirements relevant to their work and this must be documented.
16.3 Representatives must pass the appropriate ABPI representatives examination, as specified in Clause 16.4. They must take the appropriate examination within their first year of such employment. Prior to passing the appropriate examination, they may be engaged in such employment for no more than two years, whether continuous or otherwise.
16.4 The Medical Representatives Examination is appropriate for, and must be taken by, representatives whose duties comprise or include one or both of:
The Generic Sales Representatives Examination is appropriate for, and must be taken by, representatives who promote medicines primarily on the basis of price, quality and availability.
16.5 Persons who have passed the Medical Representatives Examination whose duties change so as to become those specified in Clause 16.4 as being appropriate to the Generic Sales Representatives Examination are exempt from the need to take that examination.
Persons who have passed the Generic Sales Representatives Examination whose duties change so as to become those specified in Clause 16.4 as being appropriate to the Medical Representatives Examination must pass that examination within two years of their change of duties. They must take the examination within one year of their change of duties.
16.6 Details of the numbers of medical and generic sales representatives who have passed the respective examinations above, together with the examination status of others, must be provided to the Prescription Medicines Code of Practice Authority on request.
Extensive in house training on the Code is carried out by companies and by the Prescription Medicines Code of Practice Authority.
In addition, the Authority runs seminars on the Code which are open to all companies and personnel from advertising agencies, public relations agencies and the like which act for the pharmaceutical industry. Details of these seminars can be obtained from the Authority.
Prior to passing the appropriate ABPI examination, representatives may be engaged in such employment for no more than two years, whether continuous or otherwise and irrespective of whether with one company or with more than one company. A representative cannot, for example, do eighteen months with one company and eighteen months with another and so on, thus avoiding the examination.
In the event of extenuating circumstances, such as prolonged illness or no or inadequate opportunity to take the examination, the Director of the Prescription Medicines Code of Practice Authority may agree to the continued employment of a person as a representative past the end of the two year period, subject to the representative passing the examination within a reasonable time.
Similarly, in the event of failure to take the examination within the first year, the Director may agree to an extension, subject to the representative taking the examination within a reasonable time.
Service as a representative prior to 1 January 2006 by persons who were exempt from taking the appropriate examination by virtue of Clause 16.4 of the 2003 edition of the Code does not count towards the two year limit on employment as a representative prior to passing the appropriate examination.
The ABPI examinations for medical representatives and generic sales representatives are based on a syllabus published by the ABPI. The syllabus is complementary to, and may be incorporated within, the company’s induction training which is provided to representatives as a prerequisite to carrying out their function.
The supplementary information to Clause 16.3 relating to the time allowed in which to take and pass the examination applies equally to persons who have passed the Generic Sales Representatives Examination but who now have to pass the Medical Representatives Examination.