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Article R5132-94 of the French Public Health Code

Persons engaged in national and international trade are required to draw up an annual summary statement indicating for each psychotropic substance or medicinal product containing it: 1° The quantities acquired on the national market ; 2° Quantities imported ; 3° Quantities sold on the national market; 4° Quantities exported; 5° Stocks. This statement, which covers the previous calendar year, is sent to the Director General of the Agence nationale de…

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Article R5132-95 of the French Public Health Code

The provisions of article R. 5132-79, with the exception of those set out in 5° and 6° of the said article, apply to containers or packaging containing psychotropic substances or their preparations. The label must also bear : 1° For substances or preparations covered by list I, a skull and crossbones printed in black on a yellow orange square background of sufficient size; this square is placed in the top…

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Article R5132-96 of the French Public Health Code

The managers of the establishments mentioned in articles L. 5124-2 and L. 5142-1 carrying out operations relating to medicinal products containing one or more psychotropic substances are subject to the provisions of articles R. 5132-91 to R. 5132-94.

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Article R5132-97 of the French Public Health Code

The following definitions apply 1° Drug dependence: a set of behavioural, cognitive and physiological phenomena of varying intensity, in which the use of one or more psychoactive substances becomes a high priority, the essential characteristics of which are the obsessive desire to obtain and take the substance or substances in question and the constant search for them; the state of dependence may result in the self-administration of these substances in…

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Article R5132-99 of the French Public Health Code

The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing addictovigilance. It defines the guidelines, leads and coordinates the actions of the various parties involved and ensures compliance with the monitoring procedures organised by this section.

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Article R5132-100 of the French Public Health Code

Persons manufacturing or marketing the substances, plants, medicinal products and other products mentioned in article R. 5132-98 shall, at their request, provide the Director General of the Agence nationale de sécurité du médicament et des produits de santé with all information relating to drug dependence and abuse concerning their products, as well as information concerning their sale.

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Article R5132-101 of the French Public Health Code

The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narcotics Control Board of the United Nations and to the World Health Organisation in application of the international conventions on narcotic drugs and psychotropic substances.

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Article R5132-102 of the French Public Health Code

Any doctor, dental surgeon or midwife who becomes aware of a serious case of pharmacodependence, abuse or misuse of a substance, plant, medicinal product or other product mentioned in article R. 5132-98 must immediately report it to the centre for assessment and information on pharmacodependence in whose territory the case was discovered. Similarly, any pharmacist who becomes aware of a serious case of pharmacodependence, abuse or serious misuse or serious…

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Article R5132-103 of the French Public Health Code

Any company or organisation exploiting a medicinal product or product mentioned in article R. 5132-98 must immediately report any serious case of pharmacodependence, abuse or misuse of this medicinal product or product of which it is aware to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

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