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Article R1261-29 of the French Public Health Code

The ministerial authority renews the authorisation on the basis of the information mentioned in article R. 1261-25 and the establishment’s internal control report and, for activities that are subject to accreditation or that form part of an establishment’s research programme, the evaluation report by the Haut Conseil de l’évaluation de la recherche et de l’enseignement supérieur (High Council for the Evaluation of Research and Higher Education).

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Article R1261-30 of the French Public Health Code

I.-The authorised establishment must be able to provide the administrative authority with the following information at any time: 1° The number of donations of human remains received each year; 2° The medical teaching activities and research projects undertaken; 3° The number and nature of consultations with ethical bodies; 4° Staff movements; 5° Staff training initiatives. II – The authority that issued the authorisation may also request information from the establishment…

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Article R1261-31 of the French Public Health Code

I.-Any change to the information contained in the application for authorisation or renewal of authorisation must be brought to the attention of the establishment’s supervisory ministers without delay. The latter may request any additional information in order to ensure that the modification in question does not affect compliance with the applicable legislative and regulatory provisions. II.-In particular, the following must be notified to the establishment’s supervisory ministers: 1° Any change…

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Article R1261-32 of the French Public Health Code

The structures receiving the bodies shall set up an information system shared with the ministerial authority for statistical, budgetary and financial purposes. Establishments authorised in application of the second paragraph of article L. 1261-1 shall be responsible for the computer register required to implement the missions defined in this chapter. An order by the Minister for Higher Education, after consultation with the Commission Nationale de l’Informatique et des Libertés, shall…

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Article R1261-33 of the French Public Health Code

I.-In the event of an infringement of the applicable legislative and regulatory provisions, observed by the inspection bodies or the Inspectorate General to which the establishment reports or any other authority, the authorisation may be suspended or withdrawn by decision of the ministers responsible for the establishment. The ministers responsible may also, on the recommendation of the inspection bodies or the Inspectorate General to which the establishment reports, at any…

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Article R1310-1 of the French Public Health Code

The Regional Prefect shall adopt the provisions necessary to implement the national plan for the prevention of health risks linked to the environment after examining the joint proposals of the Director General of the Regional Health Agency and the Regional Director for the Environment, Planning and Housing. For matters falling within the remit of the Regional Health Agency as defined in articles L. 1431-1 and L. 1431-2, the project approved…

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Article R1311-1 of the French Public Health Code

The provisions of this section apply to the use of skin-invasive tattooing techniques, including the permanent make-up technique, and body piercing, with the exception of piercing of the auricle and the wing of the nose when carried out using the ear piercing gun technique.

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Article R1311-2 of the French Public Health Code

Persons carrying out the techniques referred to in Article R. 1311-1 must declare this activity to the Director General of the Regional Health Agency responsible for the place where this activity is carried out. The cessation of this activity must be declared to the same authority. The procedures for these declarations are laid down by order of the Minister for Health.

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Article R1311-3 of the French Public Health Code

Persons implementing the techniques referred to in article R. 1311-1 must have undergone training in the hygiene and health conditions provided for in article R. 1311-4. An order by the Minister for Health determines the categories of establishments and the organisations authorised by the Director General of the Regional Health Agency to provide this training, as well as the content of this training and the diplomas accepted as equivalent.

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Article R1311-4 of the French Public Health Code

The techniques referred to in article R. 1311-1 are used in compliance with general health and hygiene rules. In particular, it complies with the following rules: -equipment penetrating the skin barrier or coming into contact with the client’s skin or mucous membrane and direct supports for this equipment are either single-use and sterile, or sterilised before each use; -the premises include a room exclusively reserved for performing these techniques. The…

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