Clause 8 Certification and Examination
(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.
(14.2) All events/meetings involving travel outside the UK, unless the company’s only involvement is to support a speaker to present at the meeting, must be certified in advance as set out in Clause 8.1 or by an appropriately qualified person signatory (AQP signatory). That person does not need to be either a registered medical practitioner or a pharmacist registered in the UK.
(14.3) The following must be certified in advance in a manner similar to that provided for by Clause 8.1:
• educational material for the public or patients issued by companies which relates to diseases or medicines but is not intended as promotion for those medicines
• material relating to working with patient organisations as described in Clause 27 and its supplementary information
• material relating to collaborative working as described in Clause 20 and its supplementary information
• material and items for patient support whether provided directly to patients or to health professionals to be passed on to patients as described in Clauses 19.2, 26.3 and associated supplementary information
• the written agreement for donations and grants, including where relevant internal company and service provider instructions as described in Clause 23 and its supplementary information
• (25.2) protocols relating to non-interventional studies.
(14.4) The names of those nominated as signatories as set out in Clauses 8.1 and 8.2, together with their qualifications, must be notified in advance to the Advertising Standards and Outreach Unit, Vigilance and Risk Management of Medicines Division of the Medicines and Healthcare products Regulatory Agency (MHRA), and to the Prescription Medicines Code of Practice Authority (PMCPA). Changes in the names of nominees must be promptly notified.
(14.5) The certificate for promotional material must certify that the signatory has examined the final form of the material to ensure that in their belief it is:
• in accordance with the requirements of the relevant regulations relating to advertising and this Code
• not inconsistent with the marketing authorisation and the summary of product characteristics
• a fair and truthful presentation of the facts about the medicine.
The certificate for material covered by Clause 8.3 above must certify that the signatory has examined the final form of the material to ensure that in their belief it complies with the Code.
Material which is still in use must be recertified at intervals of no more than two years to ensure that it continues to conform with the relevant regulations relating to advertising and the Code.
The certificate for events/meetings involving travel outside the UK must certify that the signatory has examined all the proposed arrangements and that, in their belief, they are in accordance with the relevant regulations relating to advertising and the Code.
(14.6) Companies must preserve certificates. Material in the form certified and information indicating the persons to whom it was addressed, the method of dissemination and the date of first dissemination must also be preserved. In relation to certificates for events/meetings involving travel outside the UK, details of the programme, the venue, the reasons for using the venue, the audience, the anticipated and actual costs and the nature of the hospitality and the like must also be preserved.
Companies must preserve certificates and the relevant accompanying information for not less than three years after the final use of the material or the date of the event/meeting and produce them on request from the MHRA or the PMCPA.