The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date of receipt of the complete application. If no decision has been taken by the end of this period, the application will be rejected. If the Director General of the Agence nationale de sécurité du médicament…
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the periodic collection of information concerning efficacy and adverse reactions and the transmission of this information to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dossier, the model for which is laid down by decision of the Director General of the National Agency for the Safety of Medicines and Health Products. The decision of the Director General of the Agency is taken within…
In the event of failure to comply with the legislative and regulatory requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or where it appears, particularly following evaluation, that the benefit/risk balance of the medicinal product is not favourable or that the claimed therapeutic effect is lacking, or in the event of danger to public health, the authorisation may be suspended…
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
For the application of the provisions of this chapter, army hospitals and the army blood transfusion centre shall be regarded as health establishments and a blood transfusion establishment respectively.
The information contained in advertising for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therapeutic strategies recommended by the Haute Autorité de santé referred to in article L. 5122-2. All advertising for a traditional herbal medicinal product includes, in addition to the information provided for in articles R. 5122-3 and R. 5122-8, the words:…
The company marketing a medicinal product shall set up an advertising department within the meaning of article L. 5122-1, under the supervision of the pharmacist responsible, which shall ensure compliance with the provisions of sections 1 to 3 of this chapter, and in particular the scientific validity of the information disseminated. The company keeps a copy of each advertisement it issues for a period of three years from the date…
When a medicinal product is the subject of a reassessment of the risk-benefit balance, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform the manufacturer without delay. He shall also inform the operator without delay of the completion and outcome of the reassessment. If the reassessment results in a change to the marketing authorisation or registration requiring a change to the…
When permitted under the provisions of Article L. 5122-6, advertising of a medicinal product to the general public : 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as a medicinal product; 2° Contains at least : a) The name of the medicinal product and the common name ; b) Information essential for the proper use of…
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75001, Paris France
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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
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