WHEN aRMMs ARE TO BE EXPECTED

June 27, 2024 — published by Pyramidale Communication,
medical communications agency

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WHEN aRMMs ARE TO BE EXPECTED… THE ESSENTIALS:^1-3

aRMMs (Additional Risk Reduction Measures) are tools or documents intended for healthcare professionals and/or patients to prevent or reduce the likelihood of adverse effects associated with exposure to a drug, their severity, and/or their impact on patients.
aRMMs may take the form of letters to healthcare professionals, information or educational documents for healthcare professionals and/or patients and their caregivers, or restricted access programs.
aRMMs may be determined at the time of marketing authorization or at any time during the life of the drug following the evaluation of a safety report. They may concern one or more manufacturers if the molecule in question is manufactured by multiple laboratories.
The release of aRMMs requires prior authorization by the ANSM, which also validates the communication methods.

aRMMs: WHAT ARE THEY?^1-2

aRMMs (Additional Risk Reduction Measures) aim to prevent or reduce the likelihood of adverse effects occurring, their severity, and/or their impact on the patient by using tools intended for healthcare professionals and/or patients.
aRMMs may be required by national or European health authorities when a need is identified in the context of the RMP (Risk Management Plan), at MA approval, or at any time following the evaluation of a safety notification.

aRMMs may take the form of letters to healthcare professionals, information or educational documents for healthcare professionals and/or patients and their caregivers (guides, checklists, brochures, patient cards, training slideshows, etc.), or restricted access programs (controlled distribution, pregnancy prevention programs).

The ANSM controls both the content of these documents and their distribution methods.

Ces mesures s’appliquent également aux spécialités génériques et aux spécialités disposant d’une autorisation d’importation/distribution parallèle.

WHAT ARE THE PROCEDURES FOR APPLYING FOR aRMMs AUTHORIZATION?^2-4

aRMMs may involve one or more manufacturers if the molecule is produced by several laboratories.

1. Distribution involving a single laboratory

The application must be submitted to the ANSM at least two months before the measures are implemented. Please note: in general, marketing of the product may be conditional on aRMMs distribution.

2. Distribution involving multiple laboratories (brand-name and/or generic)

The ANSM notifies all marketing authorization holders (with a copy to professional organizations) about aRMMs established at national and/or European level and of the obligation to pool the design. Marketing authorization holders must coordinate the design and distribution of aRMMs. The professional organizations appoint two representatives; one of the two manufacturers will be the sole point of contact with the ANSM.

WHAT ARE THE REQUIREMENTS FOR aRMMs PRESENTATIONS?²

The requirements for aRMMs presentations are based on the European Good Pharmacovigilance Practice guidelines (GVP – Module XVI and its addendum).

Documents must be clear, concise, and focused on preventing risks identified in the RMP that justify aRMMs.
The terminology used must be appropriate for the recipient and easily understood by patients.

The purpose of the material must be stated in the cover or introduction, and a statement must encourage healthcare professionals to consult the document(s) before prescribing, dispensing, or administering the product and, where applicable, to give patients the document(s) intended for them.
In addition, the documents must include statements encouraging the reporting of adverse effects on documents intended for healthcare professionals and patients.

HOW DOES THE ANSM EVALUATE aRMMs?²

The ANSM will acknowledge receipt of the request by email within 15 days and provides a provisional evaluation schedule, which will be at least two months (the maximum period in the case of aRMMs for products already on the market following the assessment of a new safety signal). The schedule may be suspended if the ANSM requests the submission of new draft tools, for example due to significant corrections or poor-quality translations.

At the end of the evaluation procedure, the ANSM sends its comments to the laboratory and specifies the communication procedures that must be implemented.

For any new document or new safety data, a paper copy must be provided in addition to any digital media, unless the laboratory(ies) can justify an exception. For minor updates and documents adapted for generics, electronic distribution is preferred unless otherwise justified by the ANSM.

For new medicines, documents must be distributed no later than the date of actual marketing of the product.

For medicines already on the market, the documents must be distributed within a maximum of 30 days following receipt of the ANSM’s comments, accounting for the time needed for printing and distribution.

WHAT ARE THE PROCEDURES FOR POSTING aRMMs DOCUMENTS ONLINE?^2,5

The posting of aRMMs documents on a laboratory’s website must comply with the Charter for the communication and promotion of medical products (medicines and medical devices) on the internet and e-media, as published on the ANSM website.

The documents may be posted on the laboratory’s institutional website in the non-promotional “Product Information” section (unsecured). Where applicable, a notice should encourage patients to consult their healthcare professional if they have not received these tools or documents, as these materials are intended to support dialogue with healthcare professionals and not replace it

A website dedicated to the Risk Management Plan may also be considered in the communication plan submitted to the ANSM, under certain conditions.⁶

The list of aRMMs in progress is available on the ANSM website.
For further information of aRMMs, see the notice to marketing authorization holders, which can be downloaded below.

Coming up in our next article:

CNOM statement: which regime to choose, declaration or authorization?

References:

VIDAL – Pharmacovigilance et gestion des risques : plans de gestion des risques et mesures additionnelles de réduction des risques.
ANSM – Avis aux titulaires d’AMM : Modalités de soumission et de présentation des mesures additionnelles de réduction du risque (MARR).
ANSM – Mesures additionnelles de réduction du risque (MARR).
CIRCULAIRE DGS/DSS/DGOS/PP2/1C/PF2/PF4/2014/144 du 8 juillet 2014.
Charte de l’information promotionnelle : https://ansm.sante.fr/uploads/2021/03/24/20210324-charte-communication-promotion-produitssante.pdf
Avis aux titulaires d’AMM : Modalités de soumission et de présentation des mesures additionnelles de réduction du risque (MARR). https://ansm.sante.fr/uploads/2020/11/24/soumission-marr-2017-2.pdf

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