Clause 16 - Training

Clause

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

  • Clause 16.1 Scope of the Code

    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.

  • Clause 16.1 Training

    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.

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.

most recent cases See all Applicable Code year
Applicable Code year

Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
AUTH/2928/1/17 and AUTH/2929/1/17 - Anonymous v Pfizer and Novartis Pharmacovigilance compliance, promotion of an unlicensed indication and breach of undertaking Breach: 2, 3.2, 9.1, 7.2, 15.9, 29 No breach: 2, 3.2, 7.2, 9.1, 15.6, 15.9, 16.2, 25.1, 29 Applicable Code: 2016 Received: 04 January 2017 Completed: 06 July 2017

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.

  • Clause 16.3 Examinations

    The ABPI offers two examinations and further details can be obtained from the ABPI.

    Examinations may also be offered by other providers. A company using an examination provider other than the ABPI must be able to demonstrate that its examinations are at least equivalent to those offered by the ABPI. The syllabus studied should be mapped to and meet the requirements in the published ABPI standards. The assessment must be under invigilated examination conditions.

    The ABPI Medical Representatives Examination is appropriate for representatives whose duties comprise or include one or both of:

    • calling upon doctors and/or dentists and/or other prescribers
    • the promotion of medicines on the basis, inter alia, of their particular therapeutic properties.

    The ABPI Generic Sales Representatives Examination is appropriate for representatives who promote medicines primarily on the basis of price, quality and availability to those who do not prescribe medicines.

    The ABPI examinations for medical representatives and generic sales representatives are based on material published by the ABPI.

    Persons who have passed the ABPI Medical Representatives Examination or similar whose duties change to those specified for generic sales representatives do not need to take another examination. However, persons who have passed the ABPI Generic Sales Representatives Examination or similar whose duties change to those specified for medical sales representatives must take an appropriate examination within one year of their change of duties and pass it within two years.

  • Clause 16.3 Accredited Examinations

    Representatives commencing such employment on or after 1 October 2014 must take an accredited examination. It was recommended that representatives commencing such employment between 1 January 2014 and 30 September 2014 also took an accredited examination.

    The unaccredited examination ceased on 31 December 2015 and therefore a candidate who has passed part of an unaccredited ABPI examination but did not complete it by 31 December 2015 will have to transfer to an accredited examination. The limitations on time within which representatives must pass an examination, which are set out in Clause 16.3 and its supplementary information, must be borne in mind.

    A candidate who has taken part of an ABPI examination who wishes to transfer to a new provider will have to take the whole of the new provider’s examination. Similarly, a candidate who has taken part of an alternative provider’s examination who wishes to transfer to an ABPI examination will have to take the whole of that examination. This will not apply if it can be demonstrated that the units already passed are equivalent to those of the new provider whether that is an ABPI examination or an alternative provider’s examination.

  • Clause 16.3 Information from Examination Provider

    A company must take steps to ensure that its examination provider would respond to requests for information from the Authority.

  • Clause 16.3 Time Allowed to Pass an Examination

    Prior to passing an appropriate 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, work eighteen months with one company and eighteen months with another and so on, thus avoiding an examination. Maternity or paternity leave does not count towards the specified time periods.

    In the event of extenuating circumstances, such as prolonged illness or no or inadequate opportunity to take an appropriate 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 an appropriate examination within a reasonable time.

    Similarly, in the event of failure to take an appropriate examination within the first year, the Director may agree to an extension, subject to the representative taking an examination within a reasonable time.

    An application for an extension should be made on a form available from the Prescription Medicines Code of Practice Authority. It should preferably be made by the company rather than the representative.

    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.

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.

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