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Annexes to article D3512-9-5

Article Annexe I of the French Public Health Code

INFORMATION AND DOCUMENTS TO BE SUPPLIED BY LABORATORIES IN THE APPLICATION FOR APPROVAL The application file shall include the following information and documents:1. The name and address of the applicant organisation;2. The legal status and, where applicable, the composition of the board of directors of the applicant organisation;3. The name and address of the laboratory carrying out the analyses, if different from those of the applicant organisation;4. The date on…

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Article Annexe II of the French Public Health Code

INFORMATION AND DOCUMENTS TO BE PROVIDED BY LABORATORIES IN THE APPLICATION FOR RENEWAL OF APPROVAL The application for renewal of approval must include the following information and documents:1. Updated documents from the application file;2. A report describing the activity (number of analyses performed) by category, during the period since the previous approval.Three copies of the completed application for renewal of approval must be sent by post with acknowledgement of receipt…

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Article Annexe III of the French Public Health Code

INFORMATION AND DOCUMENTS TO BE SUPPLIED BY LABORATORIES IN THE APPLICATION FOR MODIFICATION OF APPROVAL The application file for modification of approval includes the following information and documents:1. Updated documents from the application for approval;2. A list of analyses for which suspension or extension of approval is requested;3. A report describing the activity (number of analyses performed) by category for which the extension of approval is requested.The application for modification…

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