On May 19, 2016, the French National Drug and Health Product
Authority ("ANSM") posted on its website its first two
financial penalty decisions, adopted on May 12, 2016. The May 2016
decisions were taken against two medical device manufacturers that
had advertised their products (through an ad in professional
publications or direct mail) without a prior authorization by the
ANSM. These decisions remained available on the ANSM website for
one month. While the ANSM has been empowered by an Act dated December 29, 2011, to impose financial penalties on health care companies
("HCCs"), the French authorities had not taken such
opportunity until May 2016. The industry was expecting the ANSM to
start using financial penalties, considering the ANSM's
increasingly stringent policy.
Financial penalties may become another powerful tool against HCC,
as they are based on the annual turnover of an HCC for all or part
of the products sold in France (not including exports or taxes),
although the financial penalties cannot reach more than €1
million. The penalties imposed in May 2016 were respectively
€28,756 and €315. It seems, based on the explanations
given by the ANSM for the most lenient decision, that the decision
to impose a small penalty was based on the diligence shown by the
HCC to take corrective measures regarding the noncompliance.
Noncompliance that may result in financial penalties by the ASNM
include in particular violation of pharmacovigilance obligations,
noncompliance with GMP, and failure to make mandatory notifications
to the ANSM regarding the level of sale or stock of some products,
and also violation of advertisement regulations, regarding
pharmaceutical specialties as well as medical devices.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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