Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Update: French Decree No. 2012-743, No. 2012-744 (Loi Bertrand)

Posted by crimsonlanguage on 2012/12/19

As a result of the Mediator drug and PIP breast implant scandals, the French government is implementing a number of new controls on medical device advertising (see previous post and press release) – the new law comes into force on Jan 1, 2013. If you haven’t assessed your advertising materials for compliance, you should do so right away.

Some updates for your information below:

Affected advertising items
Brochures, print advertising, press releases, white papers, scientific articles, conference booth materials, PowerPoint presentations, letters, emails, etc. – guidance on websites is forthcoming.

Regulations
In addition to common-sense requirements (no deceptive advertising), there are a number of other requirements:
– Information in the ad must be up-to-date, correct, verifiable, legible and complete to enable assessement of the claims of the product
– Ads must be in French. English can be used for articles or white papers, but must also have compliance info in French attached
– Recommendations by scientists or HCPs is NOT permitted.
– Quotations must be reliable and the source attributed and must be legible.
– Non-compliant websites must NOT be advertised (e.g. reference to website removed from email signature)
– All digital advertising material must include the information below

Compliance information that must accompany all advertising
Registered name of product
Intended use
Manufacturer name
Device class
Notified Body
Invitation to attentively read instructions on notice for use
Statement to carefully read IFU
Reimbursement info
Date of publication
Internal reference number (high-risk device ads must be pre-approved by ANSM)

ANSM provides statement for booth graphics that refers to compliant, printed materials

ANSM text for smaller advertising pieces
Dispositif médical ou, CE (n° notified body), consultez la notice / consultez la l’étiquetage pour plus d’informations

For materials that reference a number of products
Dispositifs médicaux, consultez les notices/ consultez les étiquetages spécifiques à chacun pour plus d’information

If you want to learn more about the French Decree please send email to info@crimsonlanguage.com

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

 
%d bloggers like this: