Clause 8 Certification and Examination

An acceptable way to comply with Clause 8.1 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 8.6.

All promotional material must be certified in this way, including audio and audiovisual 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.

Companies should be aware that if they use a non-promotional item for a promotional purpose, it would need to be certified.

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 the item has been examined and signed in its final form to ensure it accurately reflects the content and presentation certified electronically. In such circumstances, the material will have a certificate and a declaration approving the final form and both must be preserved as they form the certification of the item. The examination of the printed form can be carried out by a signatory, an appropriately qualified person signatory (AQP signatory) or an appropriately qualified person (AQP).

In certifying audio and audiovisual material and promotional material on databases, interactive systems and the internet, companies must ensure that a written transcript of the material is available, 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.

See also the supplementary information to Clause 11 regarding the certification of promotional material to be used at international conferences.

When certifying dynamic content such as websites etc care must be taken to ensure the dynamic content meets the requirements of the Code as a standalone item. As the final form is not static, consideration needs to be given to the context in which it appears but each possible combination does not need to be certified.

In deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outside the industry, length of service and seniority. In addition, signatories must have an up-to-date, detailed knowledge of the Code. The registered medical practitioner should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge.

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 event/meeting, each company should ensure that the arrangements for the event/meeting are acceptable.

Under co-promotion arrangements or other arrangements where companies work together, such as collaborative working projects, the companies concerned can agree to have only one final signatory to certify on behalf of all the companies. This must all be agreed beforehand and the MHRA and the PMCPA must be informed in advance who the signatory 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.

It is possible for a company to have different individuals who would act as an AQP for examination depending on their skill sets and the material and activities etc being examined. For example, an individual with proof reading skills could examine and sign the final form of printed material which has been certified electronically as set out in the supplementary information to Clause 8.1. It is unlikely that this AQP would also have the necessary skills to examine market research material to ensure it does not contravene the Code as set out under the supplementary information to Clause 8.3.

UK companies have responsibilities under the Code for events/meetings which they organise and when UK delegates are supported and/or UK speakers are contracted to go to events/meetings outside the UK. Clauses 24, 28, 29, 30 and 31 in relation to disclosure of transfers of value will also need to be followed.

When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, 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.

If the company’s only involvement is to support a speaker to present at the event/meeting and there is no pharmaceutical company involvement with the event/meeting at all, for example, a learned society event/meeting, then neither certification nor examination is required.

When a pharmaceutical company based outside the UK arranges via a UK company for a UK speaker to present at an event/meeting to be held outside the UK, then that speaker’s presentation materials do not need to be certified or examined by the UK, provided there are no UK delegates and the UK company has no role whatsoever in relation to the event/meeting or the presentation. In such circumstances, the event/meeting arrangements, in as much as they apply to the UK speaker, will not have to be certified or examined.

In deciding whether someone other than a registered medical practitioner or a pharmacist registered in the UK is appropriately qualified to certify events/meetings involving travel outside the UK (AQP signatory), account should be taken of relevant experience both within and outside the industry, length of service and seniority. In addition, such a person must have an up-to-date and detailed knowledge of the Code.

It is possible for a company to have different individuals who would act as an AQP for examination depending on their skill sets and the material and activities etc being examined. For example, an individual with proof reading skills could examine and sign the final form of printed material which has been certified electronically as set out in the supplementary information to Clause 8.1. It is unlikely that this AQP would also have the necessary skills to examine market research material to ensure it does not contravene the Code as set out under the supplementary information to Clause 8.3.

Material issued by companies which is not required to be certified under the Code should be examined by a signatory or an AQP, who needs not be a signatory, to ensure that it does not contravene the Code or the relevant statutory requirements. Such material might include 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.

The names and qualifications of signatories and changes to them should be notified to the MHRA by email to signatories.advertising@mhra.gov.uk. The PMCPA can be notified by completing the nominated signatory form which can be found at www.pmcpa.org.uk. The names and qualifications to be sent to the MHRA and PMCPA are those of the registered medical practitioner or the pharmacist registered in the UK or, if the product is for dental use only, a UK registered dentist as set out in Clause 8.1 and the AQP signatory as set out in Clause 8.2.

The MHRA is entitled to request details 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 8.6 is applicable. There is further information in the MHRA Blue Guide.