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Promotional materials: what is the mandatory information that must not be omitted?
April 18, 2024 — published by Pyramidale Communication,
medical communications agency
Promotional materials: the keys to anticipating, planning, and successfully submitting your ansm filings!
Are you a product manager or assistant product manager in the pharmaceutical industry and want to understand everything about the rules and procedures for submitting promotional materials?
Pyramidale Communication, a medical communications agency, offers this series of exclusive articles to help you anticipate, plan, and succeed in your communications campaigns!
Mandatory information for promotional materials intended for healthcare professionals: the essentials1,2
- All promotional materials must include 5 mandatory statements.
- Additional information required under Article R.5122-8 of the CSP may be made available via a link to the medicinal product information sheet in the public medicines database.
– Prior to marketing, this link may refer to the drug directory on the ANSM medicines directory or to the EMA website.
– This reference may be provided via a QR code (print materials) or a hyperlink (digital materials). - Safety information must be included on all promotional materials, with some exceptions (see below).
- 6 parameters must be taken into account to ensure adequate readability.1,2
What are the five mandatory statements on all promotional documents intended for healthcare professionals?1-4
All promotional materials intended for healthcare professionals (HCPs) must include the following information in accordance with Article R.5122-8 of the CSP :
- Brand Name, medicinal product and International Nonproprietary Names ;
- Therapeutic indication(s) and, where applicable, its place in the therapeutic strategy* ;
- Safety information* ;
- Conditions of prescription and dispensing ;
- Reimbursement status by health insurance schemes or approval by public authorities.
* according to the terms described in the applicable recommendation.
What other information must be accessible?
Other information provided for in Article R.5122-8 of the CSP may be available on these documents via a link to the medicinal product information sheet in the public medicines database.5
Practical! Since April 2019, the ANSM has authorized the use of a QR CODE to replace the mandatory information (R.5122-8 of the CSP) on printed promotional materials intended for healthcare professionals.
Safety informations: which promotional materials are concerned?6
- All promotional materials (sales aids, slide deck, brochures, brief information documents, posology sheets, etc.) with the exception of: press advertisements, booth panels/posters, mailing, faxes without quantified efficacy data, invitation cards, small-format promotional materials.
- Emailings: a direct access path to this safety information must be provided (unless the purpose of the email is to link to a promotional document already containing such safety information). Where applicable, a link to Additional Risk Minimisation Measures (aRMMs) must be included.
- Offprints: in the case of promotional distribution, this safety information must be mentioned in an offprint holder, submitted jointly to the ANSM.
- “Administration guide” tools: should only include warnings specifically related to patient monitoring during the administration of the medicinal product. The adverse event reporting statement must also mention the risk of medication errors.
What safety data must be presented?6
1. Safety information when initiating or monitoring treatment:
- Safety data from the SmPC including at least :
– Contraindications (4.3),
– Special warnings and precautions for use (4.4),
– Fertility, pregnancy, breastfeeding (4.6),
– Type and frequency of observed adverse reactions, selected on base on two criteria: frequency ≥ 1% (4.8), the necessity of taking these safety data into account when initiating or monitoring treatment o prevent or reduce the severity of the risk (4.4). - Specify, under the list of adverse effects: “For more information on infrequent or rare adverse reactions, please refer to the Summary of Product Characteristics.
- If additional risk reduction measures (aRRM) exists, they must be consulted prior to prescribing and the relevant patient materials must be provided. A link to access these documents via the relevant section of the ANSM website may be provided.
Please note: Promotional materials must not cause healthcare professionals to disregard aRMMs validated by the ANSM, whether through their presentation or the distribution of documents with similar content.
2. Encouraging the reporting of adverse reactions:
- The promotional document must include the following statement: “Immediately report any suspected adverse reaction to a medicinal product to your regional pharmacovigilance centre (CRPV) or via https://signalement.social-sante.gouv.fr.”
- This statement must be separate from any mention of the marketing authorization holder’s pharmacovigilance contact details, and presented before such information.
- Where applicable, this statement must be adapted to specific risks (medication errors, addiction monitoring, etc.)
- Medicines under additional monitoring must display inverted black triangle ▼, along with the statement “This medicine is subject to additional monitoring to enable the rapid identification of new safety information.”
How should this safety information be presented?6
Safety information may be grouped within a clearly identified section and must not be separated from the rest of the document. In printed materials, it must appear after the presentation of clinical data, where applicable. In electronic materials, it must be easily accessible (for example, via a clearly identified tab).
The layout should be attractive, notably by highlighting section and subsection headings to allow key points to be easily identified.
In case of safety data updates6
- If new safety data lead to a modification of the Marketing Authorisation (MA), they must be incorporated into promotional materials.
- If these data have been communicated through a letter to healthcare professionals at the request of health authorities, a PRAC communication, or an information notice published on the ANSM website, promotional materials must highlight these changes (using special formatting such as bold, highlighting, or boxed text), indicating that the information is new and referring to the consultation of the official communication.
Readability of promotional documents4
The ANSM recommends six parameters to ensure optimal readability:
- Background;
- Fonts adapted and contrasting with the background;
- Highlighting of titles, subtitles, and keywords;
- No splitting of titles;
- Placement of mandatory statements in the reading direction;
- Font size, which must not be less than 8-point Pica (“corps 8”) for printed documents.
Find out more in our next article:
Promotional documents not subject to ANSM filing: It’s rare, but it does exist!
Do you have a call for tenders, a product launch, or an ANSM filing to complete?
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Our teams will support you every step of the project.
Our medical and scientific teams are at your disposal.
Our teams will support you every step of the project.
References:
- ANSM, documents de références – mentions obligatoires.
- Article R.5122-8 du code de la santé publique.
- Ministère du travail de la santé et des solidarités, charte de l’information promotionnelle : https://sante.gouv.fr/ministere/acteurs/instances-rattachees/comite-economique-des-produits-de-sante-ceps/article/charte-de-l-information-promotionnelle
- Leem, charte de l’information promotionnelle.
- http://base-donnees-publique.medicaments.gouv.fr
- ANSM, documents de références – Présentation des données de sécurité.
Contact us today to discuss how we can help you stand out in medical communications.
ARTICLE WRITTEN BY PYRAMIDALE COMMUNICATION
A Tech Health agency
