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 Clause 14 - Certification

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 pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a UK registered dentist.

The second person certifying on behalf of the company must be a senior official of the company or an appropriately qualified person.

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 unless the company’s only involvement is to support a speaker to present at the meeting.

14.3 The following must be certified in advance in a manner similar to that provided for by Clause 14.1:

  • 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 joint working between the NHS and the pharmaceutical industry as described in Clause 20 and its supplementary information
  • material relating to patient support programmes involving the provision to health professionals of items to be passed on to patients as described in Clause 18.2 and its supplementary information
  • non-promotional material for patients or health professionals relating to the provision of medical and educational goods and services, including relevant internal company instructions, as described in Clause
    19.1 and paragraph 8 of its supplementary information.

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.

Clause 14 Supplementary Information

Clause 14.1 Certification

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 copies of certificates and the final form of material etc must be preserved in order to comply with Clause 14.6.

When certifying material where the final form is to be printed companies can certify the final electronic version of the item to which no subsequent amendments will be made. When such material is printed the company must ensure that the printed material cannot be used until any one of the company’s signatories has checked and signed the item in its final form. In such circumstances the material will have two certificates and both must be preserved.

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 relevant representatives’ 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 53 give further information on certification.

See also the supplementary information to Clause 3 on promotion at international conferences regarding the certification of such material.

Clause 14.1 Certifying Digital Material

When certifying dynamic content for websites, care must be taken to ensure the dynamic content meets the requirements of the Code both as a standalone item and within the context in which it appears. The final form of digital material might not be static.

Clause 14.1 Suitable Qualifications for Signatories

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.

Clause 14.1 Joint Ventures and Co-Promotion

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 or other arrangements where companies work together, such as joint working projects, the companies concerned can agree to have only two final signatories to certify on behalf of all the companies. This must all be agreed beforehand and the Medicines and Healthcare Products Regulatory Agency and the Prescription Medicines Code of Practice Authority must be informed in advance who the signatories will be. In the event of a complaint about material certified in this way each company involved in the project/activity would be responsible under the Code.

Clause 14.2 Meetings Involving Travel Outside the UK

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.

Clause 14.3 Examination of Other Material

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.

Clause 14.3 Non-Interventional Studies

The examination of non-interventional studies is dealt with in Clause 25.2 and is not covered by Clause 14.

Clause 14.4 Notification of Signatories

The names and qualifications of signatories and changes to them should be notified to the Medicines and Healthcare Products Regulatory Agency by email to signatories.advertising@mhra.gsi.gov.uk.

>Clause 14.6 Retention of Documentation

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.