The ABPI Signatory: Certification Requirements, Role and Training

In the UK, promotional material cannot be issued until a nominated signatory has certified it. The signatory is one of the most important roles in ABPI Code compliance, and certification failures regularly appear in PMCPA cases. This guide sets out what the 2024 ABPI Code requires, based on Clause 8 (Certification and Examination) and its supplementary information.

What must be certified?

Clause 8.1 requires promotional material to be certified in its final form, “to which no subsequent amendments will be made”, by one person on behalf of the company. The supplementary information makes clear that this covers all promotional material, including audio and audiovisual material, material on databases, interactive systems and the internet, relevant representatives’ briefing materials and promotional aids.

Clause 8.3 extends certification, in a similar way, to other material, including:

• educational material for the public or patients that relates to diseases or medicines but is not intended as promotion;
• material relating to working with patient organisations and to collaborative working;
• material and items for patient support;
• the written agreement for donations and grants;
• protocols relating to non-interventional studies.

Under Clause 8.2, events and meetings involving travel outside the UK must also be certified in advance, unless the company’s only involvement is to support a speaker to present at the meeting.

Who can be a signatory?

For promotional material, the signatory must be a registered medical practitioner or a pharmacist registered in the UK, or, for a product for dental use only, a UK-registered dentist. The person certifying must not be the person who developed or drew up the material.

For meetings involving travel outside the UK, certification may instead be by an “appropriately qualified person signatory” (AQP signatory), who does not need to be a doctor or pharmacist.

The Code does not name a formal signatory exam. The supplementary information says companies should take account of product knowledge, relevant experience inside and outside the industry, length of service and seniority, and that signatories must have an up-to-date, detailed knowledge of the Code. Clause 9.1 separately requires everyone involved in preparing or approving material covered by the Code to be fully conversant with the Code and the relevant laws and regulations.

Notifying signatories

Under Clause 8.4, the names and qualifications of nominated signatories must be notified in advance to the MHRA and to the PMCPA, and changes must be notified promptly. The PMCPA provides a nominated signatories form for this; the MHRA is notified by email.

What the signatory certifies

For promotional material, the signatory certifies that they have examined the final form and that, in their belief, it:

• is in accordance with the relevant advertising regulations and the Code;
• is not inconsistent with the marketing authorisation and the summary of product characteristics;
• is a fair and truthful presentation of the facts about the medicine.

Material still in use must be recertified at intervals of no more than two years. Validated electronic signatures may be used.

Records

Clause 8.6 requires certificates and accompanying information, including the material in its certified form, to be kept for at least three years after the final use of the material or the date of the event, and produced on request from the MHRA or the PMCPA.

Material that is examined, not certified

Material that does not need certification should still be examined by a signatory or an appropriately qualified person. The supplementary information gives examples such as corporate advertising, press releases, market research material, financial information and responses to unsolicited medical information enquiries from the public.

Where it goes wrong

In one recent case, a disease-education video stayed in use after its two-year certification lapsed, after company personnel left and the material was not reassigned (CASE/0999/06/26). Our review of recent PMCPA cases covers more examples.

Practical controls

• Keep an up-to-date list of nominated signatories and notify changes promptly.
• Give every live material an owner and a recertification date.
• Build leaver handovers into the materials process.
• Train signatories and reviewers on the current Code and recent cases.
• Keep the certificate, the certified material and its distribution details together.

This article summarises the 2024 ABPI Code as published by the PMCPA. It is not legal advice.