Promotional documents not requiring ANSM filing: it’s rare, but it does happen!

May 2, 2024 — published by Pyramidale Communication,
medical communications agency

Documents promotionnels non soumis à dépôt ANSM

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 who wants to understand everything there is to know 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!

Promotional documents not subject to ANSM submission: key figures:^1,4

5 promotional materials are not subject to a HCPs visa application.
4 types of minor changes are allowed on a document with a valid HCP visa and do not require a new ANSM submission.

Which promotional materials are not subject to ansm submission?^1-3

1. Product sheets without claims:

Materials containing exclusively complete , reference information, without highlighting any part of the text:

Reference information ;
– SmPC annexes,
– and/or Transparency Commission opinions,
– and/or Therapeutic information sheet (exceptional medicines),
– EPAR (European Public Assessment Report)
Pricing and reimbursement information (13°, 14° and 15° of Art. R.5122-8 of the CSP).

These materials may use the product logo/graphic charter, excluding promotional visuals and product slogans/signatures, but must not include any promotional claims.
It is allowed to:

Present a photo of the packaging,
Mention the term “new” if the product has been marketed for less than one year.

These materials must be fully legible and indicate the date of creation or last revision.

2. INPEX sheets:

Prepared independently of the laboratory by VIDAL, based on a uniform editorial line for all medicines in the retail circuit.

3. Demonstration kits:

Intended to illustrate administration or present a medicine to healthcare professionals (dummy boxes and devices), accompanied, if applicable, by instructions described in the SmPC. They may include the product name and logo but cannot contain promotional claims. Labels such as “demonstration material” or “dummy box” must be included. If relevant, indicate that it is a placebo.

4. Order/reference letters, faxes, or mailings:

Include only commercial or administrative information for product ordering or referencing, without promotional claims.

5. Launch letters/faxes/mailings for generic products
Include only information required in the “generic product sales catalog” guidance, without promotional claims.

Which modifications exempt from ANSM submission for documents with a valid visa?⁴

Certain factual corrections may be implemented without prior ANSM authorization. Documents must indicate the date of their last modification. These modifications are allowed provided that the visa remains valid and without any extension of its initial validity period; the internal reference number – ANSM visa – remains unchanged.

1. Content modifications:

Updating mandatory information (full SmPC) without impacting the promotional content,
Modifying price or reimbursement rate, registration in the JORF (Official Journal of the French Republic) of reimbursement / public entity approval, registration in the Generic Register;
Modifying administrative or legal details regarding the marketing authorization holder;
Adding or removing the black inverted triangle and its accompanying statement;
Removing the term “new” after one year;
Replacing “soon available” with ‘new’ (for 1 year) or “marketing/launch on dd/mm/yyyy”;
Removing the term “only” if a competitor exists;
Updating of the number of years on the market, sales/prescription data (if source unchanged);
Awarding a prize or distinction;
Translating of an offprint (TAP) another language (if complete and faithful to the original text),
Updating bibliographic references: from online to print, publication in peer-reviewed journal of SmPC studies (without modifying presented data),
…

2. Modification of presentation:

Changing in graphic charter/product logo (excluding promotional visuals and product slogan/signature) provided that these changes in presentation do not affect the readability or hierarchy of the information presented.

3. Modification of distribution methods:

Online publication of an Interactive Visual Aid (IVA), slide-deck, or fact sheet for remote promotional information;
Switching from a paper document to an electronic version (or vice versa), if the visa is valid, content is identical, information hierarchy is unchanged, and readability is preserved.

4. Modification of format:

Changing support size/orientation if the visa is valid, content is identical, hierarchy is preserved, and readability is maintained ;
Deriving support formats while respecting presentation requirements for each type of material:
– Press advertisement <-> poster, totem, or kakemono
– Internet banner <-> posts on application
– IVA <-> slide-deck
– Fax <-> Mail

For more information, click here

Coming up in our next article:

Promotional documents: which references to use, how to reference them?

Do you have a call for tenders, a product launch, or an ANSM filing to complete?
Please do not hesitate to contact us with any questions you may have. We are here to help!
Our medical and scientific teams are at your disposal.
Our teams will support you every step of the project.

References:

ANSM, documents de références – Supports non soumis à dépôt.
Article R.5122-8 du code de la santé publique.
Article R.5122-11 du code de la santé publique.
ANSM, documents de références – Modifications mineures pouvant être apportées sur un support disposant d’un visa PM en cours de validité.

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