ANSM filings: all the dates in your electronic calendar!

April 4, 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!

Key dates in the ansm submission calendar for HCPS¹ visas

Practical! Scan the QR codes below and add to your calendar the dates of the four submission periods in the 2024 ANSM schedule for advertising visa approval requests.

* Beyond these dates, if the ANSM does not respond, the visa is deemed tacitly granted.

What is an advertising visa for medicines?

Advertising for medicines is strictly regulated and subject to control before release. This supervision takes the form of prior advertising visa delivered by the ANSM (French National Agency for Medicines and Health Products Safety).

The term “advertising” covers announcements in the press or on television, brochures, scientific or medical publications, mailings, posters, etc. The role of the ANSM is to ensure that advertising does not pose a risk to public health, is not misleading, serves as an informative tool for healthcare professionals, complies Marketing Authorization (MA) of the medicine, and follows the therapeutic strategies recommended by the HAS (Haute Autorité de Santé, French National Authority for Health).^2-3

How do you obtain an advertising visa for medicines?

There are two regulatory pathways for advertising medicines depending, depending on the target audience:

1. Advertising to healthcare professionals (HCPs) is limited to medicines with a valid marketing authorization and must comply with its terms.
The information included in promotional materials for HCPs must be accurate, up-to-date, verifiable, and sufficiently complete to present the medicine objectively and support its appropriate use. Communication is restricted to healthcare professionals, including physicians, pharmacists, dentists, and midwives.
In this context, medical visits are governed by a specific charter that guarantees the quality of the information provided and its role in promoting the proper use of medicines.
Please note that advertising for medicines under benefit-risk re-evaluation following a pharmacovigilance report is prohibited until the procedure is completed.^2-4

2. Advertising aimed to the general public is allowed only for medicines not subject to mandatory prescription and not reimbursed by statutory health insurance schemes, provided that their marketing authorization does not prohibit or restrict advertising due to potential public health risks.
As an exception, medicines intended for smoking cessation and certain vaccines listed for public health reasons may be advertised in the interest of public health.^2-4

When to apply for an advertising visa? ^1,4-5

The schedule for advertising visa submission periods is set by the ANSM Director-General. Except in specific cases (see below), no applications can be processed outside these periods. The ANSM has 2 months from the day following the end of the submission period to notify the applicant of its decision. If no decision is issued within this two-month period, the visa is considered tacitly granted. The validity of a visa is two years.

2024 Submission Periods for HCPs visas applications (advertising to healthcare professionals):

From January 15th to February 2nd, 2024
End of evaluation period: April 3rd, 2024
From April 8th to 26th, 2024
End of evaluation period: June 27th, 2024
From July 10th to 29th, 2024
End of evaluation period: September 30th, 2024
From October 1st to 18th, 2024
End of evaluation period: December 19th, 2024

* Beyond these dates, if the ANSM does not respond, the visa is deemed tacitly granted.

2024 submission period calendar for GP visa applications (advertising to the general public):

From November 7th to 15th, 2023
End of evaluation period*: January 16th, 2024
From December 5th to 12th, 2023
End of evaluation period*: February 13th, 2024
From February 15th to 23rd, 2024
End of evaluation period*: April 24th, 2024
From March 14th to 22nd, 2024
End of evaluation period*: May 23rd, 2024
From April 29th to May 10th, 2024
End of evaluation period*: July 11th, 2024
From June 25th to July 4th, 2024
End of evaluation period*: September 5th, 2024
From August 26th to September 4th, 2024
End of evaluation period*: November 5th, 2024
From September 19th to 27th, 2024
End of evaluation period*: November 28th, 2024
From November 7th to 15th, 2024
End of evaluation period*: January 16th, 2025
From December 4th to 12th, 2024
End of evaluation period*: February 13th, 2025

* Beyond these dates, if the ANSM does not respond, the visa is deemed tacitly granted (GP visa).

In order to simplify the submission process and facilitate processing, digital submission is preferred. An online form is available for each submission period, accessible on the ANSM website a few days before the start of the submission period. Paper submissions sent by registered mail or hand delivery remain possible but should now be exceptional.

Is an advance application possible?⁴

Applications may be submitted in anticipation of the decision on the marketing authorization (MA) or its modification:

Initial European MA through centralized procedure (from positive CHMP opinion), decentralized or mutual recognition procedure (at the end of the European phase, based on the draft translation of the European MA),
Marketing authorization modifications through centralized, decentralized, or mutual recognition procedures (same conditions as for the initial MA),
Initial national marketing authorization (based on the draft marketing authorization)

Approval will only be granted if the marketing authorization is valid. Advertising materials may be released only after the competent authorities have issued their decisions. It is the responsibility of the marketing authorization holder to ensure that advertising complies with the annexes of the notified marketing authorization.

Are there exceptions for submissions outside the period?⁴

The only authorized exception applies to medicines under benefit-risk re-evaluation. If the outcome of this procedure results in a change to the marketing authorization or registration, the manufacturer must submit a new visa application in order to resume advertising. In this case, the visa application may be submitted outside the periods allocated by decision of the Director General of the ANSM.

How much does a visa application cost?⁴

All applications for a visa or visa renewal for advertising (HCPs or GP) are subject to a fee of €510 (Article 1635 bis AE of the General Tax Code).

What are the mandatory statements and special materials?

Find out in our next articles…

Do you have a call for tenders, a product launch, or an ANSM filing to complete?

Please contact us with any questions. We are here to help!

Our teams will support you every step of the project.

References:

ANSM, décision du 23/10/2023 fixant le calendrier et les périodes de dépôt pour l’année 2024, la forme et le contenu des demandes de visa des publicités pour les médicaments à usage humain.
Ministère du travail de la santé et des solidarités, médicaments : Publicité
https://sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/consulter-la-reglementation-sur-les-medicaments/article/publicite
Leem, publicité pour les médicaments : les règles
https://www.leem.org/publicite-pour-les-medicaments-les-regles
ANSM, modalités encadrant les demandes de visa de publicité pour les médicaments (GP/PM).
ANSM, effectuer une demande de visa de publicité pour les médicaments (GP/PM).

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