ANSM control over medicinal product advertising does not begin when the file is submitted. It begins while the copy is being written, when a claim drifts away from the summary of product characteristics (SmPC), or when a mandatory statement vanishes from a shortened format. The gaps we find in promotional material repeat from one file to the next. Here are twelve checkpoints, drawn from the French Public Health Code and from the doctrine published by ANSM, to run before internal approval.

Qualify the material before reviewing it

1. Is it advertising within the meaning of Article L.5122-1? The Code covers any form of information, including canvassing, prospecting or inducement, that seeks to promote the prescription, supply, sale or consumption of a medicinal product. The format does not decide the question, the purpose does. A slide, an email, a web page or an exhibition stand can fall under the same regime. The same article sets aside certain content, in particular correspondence needed to answer a specific question about a product, together with non promotional documents.

2. Who is the audience? Advertising to the general public and advertising to healthcare professionals follow two separate regimes: different statements, a different authorisation, a different submission calendar. Hybrid material is a weak point. If the content is written for prescribers, access must be restricted to healthcare professionals, and that restriction has to be real rather than merely declared.

What ANSM checks in the substance of medicinal product advertising

3. Consistency with the marketing authorisation. Article L.5122-3 restricts advertising to products holding a marketing authorisation or a registration. Article L.5122-2 requires the advertisement to comply with the terms of that authorisation. The SmPC is the pivot document: every sentence in the material must be traceable to a line of the SmPC, whether it concerns the indication, the posology, the target population, the contraindications or the warnings. A claim with no anchor in the SmPC is a finding, even where it happens to be accurate.

4. Objectivity and rational use. The same Article L.5122-2 prohibits misleading advertising and advertising that undermines public health protection. It requires an objective presentation of the product and the promotion of its rational use. In practice: no unproven superlative, no shortcut on treatment duration, no extrapolation from a surrogate endpoint to a clinical benefit.

5. The balance between benefits and risks. Safety data must remain as legible and as visible as efficacy data, and ANSM devotes a dedicated recommendation to their presentation. One rule is worth committing to memory: for vaccines, advertising to healthcare professionals must reproduce in full the recommendations of the opinion issued by the French National Authority for Health (HAS), clearly identifiable and without a footnote reference (Article L.5122-9).

6. Therapeutic positioning. Article L.5122-2 also requires compliance with the therapeutic strategies recommended by HAS. A first line claim therefore has to be consistent with the current recommendation, not only with the wording of the indication.

Mandatory statements, format by format

7. To healthcare professionals (Article R.5122-8). ANSM sets out five blocks: the name of the product, the indication together with its therapeutic positioning, the safety data, the prescription and dispensing conditions, and finally the status regarding reimbursement and approval for use by public institutions. Legibility is part of the review: the agency applies a minimum size of 7 Didot points or 8 pica points for printed material, with sufficient contrast between text and background.

8. Linking to the public medicines database. Rather than reproducing every piece of information, material may point to the public medicines database through a hyperlink or a QR code. Where several products appear on the same document, each product needs its own link. Check that the link resolves to the right product, the right strength and the right pharmaceutical form.

9. To the general public (Article R.5122-3). The material must clearly identify the product as a medicine, expressly invite the reader to read the instructions on the leaflet or on the outer packaging with care, and carry the cautionary message pointing to the pharmacist and, should symptoms persist, to a doctor. Generic medicines have their own statements. Upstream of all this, only products that are not subject to prescription and not reimbursed may be advertised to the public, apart from the exceptions provided for certain vaccination campaigns (Article L.5122-6).

Internet and social media

10. Digital material is reviewed against the charter. On 14 November 2024, ANSM updated its charter on the communication and promotion of health products on the internet and e media. It now covers medicinal products as well as medical devices, including active implantable devices and IVDs. The sensitive points are unchanged: the boundary between corporate information and advertising, the moderation of comment areas, content relayed by third parties, and audience targeting, which can put material written for prescribers in front of the general public.

The authorisation, then the life of the material

11. The advertising authorisation. Advertising to the public requires prior authorisation from ANSM, known as the visa GP (Article L.5122-8), while advertising aimed at healthcare professionals requires the visa PM (Article L.5122-9). Applications may only be filed during the windows set each year by decision of the agency's director general, and the number of windows differs between the two authorisations. The agency notifies its decision within two months from the day following the close of the submission window, and the absence of a decision amounts to acceptance. The authorisation is granted for two years.

12. Consistency over time. Approved material stays valid only for as long as its basis does. A variation that changes the SmPC, a change in reimbursement conditions or a new HAS recommendation can make sentences already in circulation obsolete. Keep an inventory of the material in circulation, recording the SmPC version each item relies on, and log the decisions taken: that is what allows a claim to be justified again two years after approval.

In practice

These twelve points make a stable review grid, best applied before internal approval rather than after it. It works better alongside an in house framework: an approved claims matrix, a glossary, layout rules. Our clients submit that kind of internal requirement so that it is checked in the same pass as the official texts, next to the pharmaceutical frameworks and ANSM doctrine. That is the work EryonOne performs: every finding quotes the exact passage of the document and the reference text, with a confidence score, while the decision to accept or dismiss stays with the expert. The report is working material, not an authorisation. The same demand for consistency applies upstream, between the patient leaflet and the SmPC that underpin everything else.

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