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Communication axis: what the ANSM recommends?
June 13, 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 or assistant product manager in the pharmaceutical industry looking to fully understand the rules and procedures for submitting promotional materials?
Pyramidale Communication, a health communications agency, offers this series of exclusive articles to help you anticipate, plan, and succeed in your communications campaigns!
Communication axis: what does the ANSM recommend? key figures:
The ANSM’s recommendations regarding the advertising of medicines to healthcare professionals cover seven areas of communication.
Communication axis: what does the ANSM recommend for advertising medicines to healthcare professionals?1
1. Compliance with the marketing authorization
Promotional materials must not anticipate the results of studies on potential changes to marketing authorizations that have not yet been submitted or are still under review by the marketing authorization committee (e.g., properties, indications, dosage). Specifically, studies on indications, dosage, or treatment duration that have not yet been validated cannot be used as the basis for advertising.
2. Change in formulation, form, or presentation
Manufacturers inform healthcare professionals of any changes in the composition and/or pharmaceutical presentation and/or method of use of a pharmaceutical product, as these changes do not always result in a name change. Advertising materials must clearly indicate “new formula” and/or “new presentation” and/or “new method of use” as applicable.
Promotion that includes information about a physiological or pathological condition that contraindicates a drug is not allowed.
4. Pharmacological properties without clinical significance validated by the Marketing Authorization (MA)
Pharmacological properties that have not been clinically validated by the MA may not be used in as a slogan, titles, or primary communication axis in promotional materials.
5. Advertising common to different dosages or pharmaceutical forms
Advertising messages must avoid any ambiguity regarding the characteristics of different presentations of a drug. Mandatory information must clearly specify the features of each presentation, especially when the wording of the therapeutic indications differs.
6. Primary and secondary endpoints of a clinical study
For objective communication about a clinical study, the focus must be on the results of the primary endpoints. Secondary endpoint results may only be included if they are published in the original article or abstract, and they must be presented alongside the primary endpoints.
7. Targeting a subpopulation
Promotional materials that are based solely on the effect of a drug on a subpopulation of patients are prohibited, unless they are methodologically robust clinical studies. If a subpopulation targeted in a promotion has been mentioned in the SmPC as having an adverse effect or requiring precautions for drug use, this must be clearly stated in the advertisement.
Coming up in our next article:
When aRMMs are to be expected…
A call for tenders, a product launch, or an ANSM submission to complete?
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- ANSM – Documents de référence : Recommandations pour la publicité des médicaments auprès des professionnels de santé : Axe de communication.
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