14.1 Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by two persons on behalf of the company in the manner provided for by this clause. One of the two persons must be a registered medical practitioner or a UK registered pharmacist or, in the case of a product for dental use only, a registered medical practitioner or a UK registered pharmacist or a dentist.
Material referred to in Clause 14.3 below must be certified by two persons one of whom must be a registered medical practitioner or, in the case of a product for dental use only, a registered medical practitioner or a dentist.
The second person certifying on behalf of the company must be an appropriately qualified person or senior official of the company or an appropriately qualified person whose services are retained for that purpose.
14.2 All meetings which involve travel outside the UK must be certified in advance in a manner similar to that provided for by Clause 14.1.
14.3 The following must be certified in advance in a manner similar to that provided for by Clause 14.1:
14.4 The names of those nominated, together with their qualifications, shall be notified in advance to the Advertising Standards Unit, Vigilance and Risk Management of Medicines of the Medicines and Healthcare products Regulatory Agency and to the Prescription Medicines Code of Practice Authority. The names and qualifications of designated alternative signatories must also be given. Changes in the names of nominees must be promptly notified.
14.5 The certificate for promotional material must certify that the signatories have examined the final form of the material and that in their belief it is in accordance with the requirements of the relevant regulations relating to advertising and this Code, is not inconsistent with the marketing authorization and the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine.
The certificates for material covered by Clause 14.3 above must certify that the signatories have examined the final form of the material and 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 meetings involving travel outside the UK must certify that the signatories have examined all the proposed arrangements for the meeting and that in their belief the arrangements are in accordance with the relevant regulations relating to advertising and the Code.
14.6 Companies shall preserve all certificates. In relation to certificates for promotional material, the 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 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 shall preserve certificates and the relevant accompanying information for not less than three years after the final use of the promotional material or the date of the meeting and produce them on request from the Medicines and Healthcare products Regulatory Agency or the Prescription Medicines Code of Practice Authority.
The certificates for material covered by Clause 14.3 above shall be preserved for not less that three years after the final use of the material and companies shall produce them on request from the Medicines and Healthcare products Regulatory Agency or the Prescription Medicines Code of Practice Authority.
An acceptable way to comply with Clause 14.1 is for the final proof to be certified but this is not obligatory provided that that which is certified is in its final form to which no subsequent amendments will be made. Companies may use validated electronic signatures for certifying material. Paper or electronic
All promotional material must be certified in this way including audio and audio-visual material, promotional material on databases, interactive data systems and the Internet and representatives’ technical briefing materials. Promotional aids must also be certified. Although not strictly promotional material they are used for a promotional purpose.
Account should be taken of the fact that a non-promotional item can be used for a promotional purpose and therefore come within the scope of the Code.
In certifying audio and audio-visual material and promotional material on databases, interactive systems and the Internet, companies must ensure that a written transcript of the material is certified including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested. Alternatively companies may certify material on interactive systems by means of producing an electronic copy, for example on a CD Rom or data stick, if the electronic copy is write protected and unable to be changed.
The guidelines on company procedures relating to the Code which are on page 51 give further information on certification.
See also the supplementary information to Clause 3 on promotion at international conferences regarding the certification of such material.
In deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outwith the industry, length of service and seniority. In addition signatories must have an up-to-date, detailed knowledge of the Code.
In a joint venture in which a third party provides a service on behalf of a number of pharmaceutical companies, the pharmaceutical companies involved are responsible for any activity carried out by that third party on their behalf.
It follows therefore that the pharmaceutical companies involved should be aware of all aspects of the service carried out on their behalf and take this into account when certifying the material or activity involved. Similarly if two or more pharmaceutical companies organise a joint meeting each company should ensure that the arrangements for the meeting are acceptable.
Under co-promotion arrangements whereby companies jointly promote the same medicine and the promotional material bears both company names, each company should certify the promotional material involved as they will be held jointly responsible for it under the Code.
When certifying meetings which involve travel outside the UK, the signatories should ensure that all the arrangements are examined, including the programme, the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.
Other material issued by companies which relates to medicines but which is not intended as promotional material for those medicines per se, such as corporate advertising, press releases, market research material, financial information to inform shareholders, the Stock Exchange and the like, and written responses from medical information departments or similar to unsolicited enquiries from the public etc, should be examined to ensure that it does not contravene the Code or the relevant statutory requirements.
The examination of non-interventional studies is dealt with in Clause 21.2 and is not covered by Clause 14.
Companies should note that the Medicines and Healthcare products Regulatory Agency is entitled to request particulars of an advertisement, including particulars as to the content and form of the advertisement, the method of dissemination and the date of first dissemination, and such a request is not subject to any time limit. This does not apply to the certificates themselves in respect of which the three year limit in Clause 14.6 is applicable.