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Decision Of 24 December 2002 Establishing A Committee On Validation Of Recommendations Of

Original Language Title: Décision du 24 décembre 2002 portant création d'un comité de validation des recommandations de

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Keywords

SANTE , FRENCH HEALTH SAFETY AGENCY FOR HEALTH PRODUCTS , AFSSPS , VALIDATION COMMITTEE , RECOMMENDATION , GOOD PRACTICE , HEALTH PRODUCT , CREATING , ROLE , COMPETENCE , RUNNING , COMPOSITION , MEMBER , MODE OF APPOINTMENT


JORF No. 6 of 8 January 2003 Page 425
Text No. 25


DECISION
Decision of 24 December 2002 establishing a committee for the validation of recommendations for good practice on health products at the French Health Products Safety Agency

NOR: SANM0224374S ELI: http://www.legifrance.gouv.fr/eli/decision/2002/12/24/SANM0224374S/jo/texte


The Director General of the French Health Products Safety Agency,
In view of the Public Health Code, and in particular Book III of the fifth Party,
Decides:

Item 1


It is created with the Director General of the French Health Products Safety Agency a committee Validation of recommendations of good practice on the drug. The validation committee shall be responsible for:
a) Validate the recommendations of good practice on health products established or updated by the scientific experts of the agency or the scientific experts to which the agency may appeal, Selected on the basis of their expertise in the relevant specialty;
b) Validate established or updated opposable medical references after reassessment of clinical relevance based on new scientific evidence.

Article 2


The Validation Committee includes:
a) The Chairman of the Commission referred to in Article R. 5140 of the Health Code Public;
b) The Chair of the Transparency Commission;
c) The President of the National Pharmacovigilance Commission;
d) The President of the National Observatory on Drug Requirements and Consumption in the Ambulatory and hospital sectors;
e) The chair of the commission responsible for advertising and dissemination of recommendations on the proper use of drugs;
f) University, hospital and liberal specialists As well as general practitioners appointed for a period of three years by the Director General of the French Health Products Safety Agency and competent in the field of the relevant medical specialties.

Article 3


The members of the expert group referred to in Article 2 shall be appointed for a period of three years, renewable by the Director General of the French Health Products Safety Agency.

Article 4


The work of the Committee is Confidential.

Article 5


The Secretariat is provided by the Directorate of Drug and Biological Products Evaluation and The direction of medico-economic evaluation and scientific information.

Article 6


The duties of committee members open Entitlement to travel and subsistence allowances under the conditions laid down in Decree No 90-437 of 28 May 1990.

Article 7


The Director of Drug and Biological Products Evaluation and the Director of Medico-Economic Assessment and Scientific Information are responsible for the implementation of this Decision, each of which will be Published in the Official Journal of the French Republic.


Done at Paris, December 24, 2002.


P. Duneton


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