Pharmacovigilance in France

With our help, specifics of the local drug safety surveillance will be no challenge for you.
Have a look below what the French national system is all about – and contact us to outsource any of your obligations.

Current status of our French pharmacovigilance services:

QPPV / Local Contact Person

AVAILABLE

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Local Literature Screening

AVAILABLE

Automated monitoring with Tepsivo Literature >

Local authorities to know

The main pharmacovigilance authority in the country is called ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé). It resides in Paris and to evaluate and monitor the safety of medicinal products is the main mission of the agency. It replaced the previous authority called AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) in 2012.

Useful information resource about French PV is the ANSM newsletter. In the past, the agency also used to share a lot of interesting data in a regularly published document called “Bulletin des vigilances” – but since 2017, new issues seem not to be produced. If you are interested in the old ones, you can still download them individually through the ANSM archive, or we collected them for you in one large pack here.

Among other important institutions are 31 regional pharmacovigilance centers – the network called RFCRPV has a website with a nice interactive map of local areas and a bulletin section. You might also find useful to check websites of the Pharmaceutical Companies Association (guidelines for drug manufacturers), the National Union of the Medical Technology Industry (guidelines for medical device manufacturers) or HAS, the National Authority for Health (health system regulations).

Not to forget, worth mentioning is the National Commission on Informatics and Civil Liberties (CNIL), where pharma companies need to file a notification before a pharmacovigilance system is set up (there is a special authorisation procedure AU-013 for data processing relating to pharmacovigilance).

Do you need some help with the communication with French authorities? We’re here for you.

History & updates of the PV system

For French speakers, a nice overview of important milestones of the French drug safety surveillance is available on the Organisation page of the already mentioned regional centres network website (just click the link and scroll down to the “Historique” section).

For others, we put together a quick English summary of the events in the following box:

1960s and 70s
Following thalidomide and distilbene cases (both drugs with serious side effects discovered after the product was already on the market), French government set up first pharmacovigilance centers to collect and monitor drug safety signals. The national structure of authorities was formalized and the drug safety network defined.

1980s and 90s
The term “pharmacovigilance” starts to appear in the Public Health Code (Amendment of Article 605). Mandatory reporting of unexpected side effects for health professionals is defined in 1984 and further extended in the 90s.

2016
The Law on the Modernisation of the French Healthcare System (2016/41) has been introduced, bringing several updates – new obligations related to traceability of products or access to public health data.

2019 – 2021
Revision of the Public Health Code, modifications related to clarification of roles and objectives of participants of the national drug safety surveillance system.

2022
ANSM publishes updated pharmacovigilance guidelines – “Bonnes Pratiques de Pharmacovigilance, May 2022”.

To keep up with future updates on French pharmacovigilance, you can subscribe to our Tepsivo News.

Pharmacovigilance legislation

In France, there is a handy website Légifrance, where you can look up, view and download a complete and most up-to-date version of French laws. For example, you can navigate through the Code de la Santé Publique – the French Public Health Code.

To save your time, we list the most important regulations related to French pharmacovigilance below, together with their short description.

Articles from the Public Health Code

The French Public Health Code includes many articles that address pharmacovigilance processes and responsibilities. Here are the main ones:

L5121-22 – the objectives of pharmacovigilance
L5121-24 – MAH’s obligation to set up and maintain a pharmacovigilance system
L5121-25 – reporting obligations of healthcare professionals
R5121-168 – periodic safety reporting (content and frequency)

Relevant laws, decrees and ordinates

There is a lot of documents that influence the Public Health Code and shape the overall national drug safety system. Following list mentions the key ones:

Loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé
Sometimes also called the “Mediator Law”, this regulation was created as a response to the Mediator scandal that uncovered gaps in the French drug safety system (the Mediator drug was linked to serious heart damage after being on the market for decades). The law established the ANSM agency, increased transparency and also established high sanctions for drug safety rules violation, together with provisions for post-marketing studies.

Décret n° 2017-884 du 9 mai 2017
Modifications to the Public Health Code regarding reporting of adverse events, transparency and overall responsibilities of authorities, healthcare professionals, pharmaceutical companies.

Ordonnance n° 2016-966 du 15 juillet 2016
Relates to the right of public to access the data about the safety of drugs.

ANSM Guidelines

The national French authority for pharmacovigilance publishes a guidelines document called “Bonnes pratiques de pharmacovigilance” available for download in a pdf format on the related ANSM page.

EU Legislation and EMA Guidelines

Since France is a member of the EU, every MAH with a product on the French market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Organization).

To navigate through the European regulations, its is useful to know following:
– EMA Pharmacovigilance System Manual
– Directive 2001/83/EC and Regulation (EC) 726/2004
– Commission Implementing Regulation (EU) 520/2012

Do you need some help with putting the French PV System together? We’re here for you.

French national databases & portals

BNPV (Base National de PharmacoVigilance)

The BNPV is the official name of the French pharmacovigilance database, sometimes also referred to as FPDB or just “the national database of the ANSM”. The database was designed to store data about all reported drug adverse events in France and contribute to the european-level database EudraVigilance.

However, as ANSM announced in 2021, a new application takes place of the database (English brochure about the system here). Both patients and professionals can now report adverse events using the “Portal des signalements“.

BDPM (Base de Données Publique des Médicaments)

The BDPM is a public database of all authorized medicines in France. It is open to everyone and allows search based on the drug name, active substance or indication.

The data provided for each medicine is quite extensive (yet only in French) with the goal of to share all important information about the product in one place. Therefore, suspected adverse effects are also listed – to find a table with their frequency, navigate to the top of the product card, click the second tab “Résumé des caractéristiques du produit” and scroll until you reach the headline “Effets indésirables”.

If you are looking for a budget-friendly tool to manage your ICSRs on both local and global level, try our Tepsivo Safety database.

Local requirements & specifics

Is LCPPV required in France?

Yes, it is obligatory to appoint a French local contact person (“RPV”). Also, bear in mind that there is another role in France called responsible pharmacist (“PR”) – do not confuse those two.

A useful FAQ is available in the middle part of this ANSM page, where many LCPPV related topics are discussed.

If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.

Let us appoint LCPPV for you >

How to report to French authorities?

In general, the local reporting requirements for documents like PSMF, PSUR, DSUR and other reports are based on the EU pharmacovigilance legislation – but also be sure to get familiar with current ANSM guidelines.

What might be interesting for you in this context is that we are currently testing a simple feature in Tepsivo platform that will allow you to automatically publish and update your PSMF or PSUR anytime, without any extra fees.

Generate reports with one-click >

What local literature to screen?

Some examples of French medicine journals to monitor:

– Revue Medicine et Philosophie
(ISSN 2650-5614)
– Bulletin de la Dialyse à Domicile
(ISSN 2607-9917)
– MTSI (ISSN 2778-2034)
– SICOT-J (eISSN 2426-8887)

Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.

Learn how to screen automatically >