Public health inspecting pharmacists and inspectors from regional health agencies who are pharmacists are authorised and sworn to investigate and record the offences referred to in article L. 5411-1 under the conditions set out in articles R. 1312-2 and R. 1312-4 to R. 1312-7.
For the application of Article L. 5412-1, the inspectors referred to in Article R. 5313-1 are authorised to investigate and establish criminal offences by a decision of the Director General of the Agency, specifying the name, capacity and qualifications of the agents concerned. The authorisation lasts for two years. It may be renewed. Authorised agents take the following oath before the judicial court in whose jurisdiction the head office of…
Medical public health inspectors and inspectors from regional health agencies who are doctors are authorised and sworn to investigate and record the offences mentioned in article L. 5413-1 under the conditions set out in articles R. 1312-2 and R. 1312-4 to R. 1312-7.
Any doctor, dental surgeon, midwife or pharmacist who fails to comply with the obligation to report immediately any serious adverse reaction suspected to be due to a medicinal product or a product within the meaning of 2° of article R. 5121-152 of which they are aware is punishable by a fifth-class fine.
Failure by the responsible person, as defined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, to make the information provided for in Article 21 of the same Regulation available to the public is punishable by a fifth-class fine.
The making available on the market, by a distributor as defined in e of paragraph 1 of Article 2 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, of a cosmetic product that does not comply with the rules laid down in terms of labelling, linguistic requirements or minimum durability date by paragraph 2 of Article 6 of the…
Repeated offences under articles R. 5431-1 and R. 5431-2 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.
Any manufacturer, importer or distributor of reagents is liable to a fine of the fifth class: 1° Placing a reagent on the market, whether free of charge or against payment, without having registered it with the Agence nationale de sécurité du médicament et des produits de santé; 2° Failing to notify the Agence nationale de sécurité du médicament et des produits de santé of any change affecting the elements of…
Failure by a manufacturer, importer or distributor of reagents to comply with the obligation to inform the user under the conditions defined in articles R. 5133-1 to R. 5133-3 is punishable by a fifth-class fine.
A manufacturer, importer or distributor who has registered a reagent is liable to a fine of the fifth class for failing to forward to the Agence nationale de sécurité du médicament et des produits de santé any information on unexpected or undesirable effects, or on shortcomings or errors, likely to be due to this reagent and of which he has become aware.
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Resources
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
