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Article D5134-10-1 of the French Public Health Code

University and inter-university student health services supply students with emergency contraception drugs under the following conditions: 1° Medicines are issued and administered free of charge to students; 2° In the case of medicines for which a doctor’s prescription is compulsory, these are prescribed and may be dispensed and administered by a doctor or midwife; they may also be dispensed and administered by a nurse working in the service on the…

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Article R5134-11 of the French Public Health Code

The provisions of the second paragraph of article R. 5122-2 and those of articles R. 5122-2-1, R. 5122-5, R. 5122-6, R. 5122-7, R. 5122-9 and R. 5122-13 to R. 5122-16 are applicable to advertising for contraceptive products and articles other than medicines and condoms, mentioned in article L. 5134-1. All elements contained in the advertising must be compatible with the marketing authorisation, where this exists.

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Article R5134-12 of the French Public Health Code

Advertising to the public for a product or object defined in article R. 5134-11 : 1° Is designed in such a way that the advertising nature of the message is obvious ; 2° Contains at least : a) The name of the product or object and the common name ; b) Information essential for the proper use of the product or object; c) An express and legible invitation to read…

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Article R5134-13 of the French Public Health Code

Advertising to the public for a product or object defined in article R. 5134-11 may not include any element which : 1° Suggest that the effect of the product or object is guaranteed or that it has no undesirable effects; 2° Emphasises that the product or object has been granted a marketing authorisation; 3° refers to a recommendation issued by scientists, health professionals or persons who, although they are neither…

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Article R5134-14 of the French Public Health Code

Advertising aimed at healthcare professionals, for a product or object defined in article R. 5134-11, is adapted to its target audience. It specifies the date on which it was drawn up or last revised and includes the following information: 1° The name of the product or object ; 2° The name and address of the company exploiting the product or object; 3° The form of use; 4° In the case…

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Article R5134-15 of the French Public Health Code

The provisions of articles R. 5122-5, R. 5122-6, R. 5122-7, R. 5122-9 and R. 5122-13 to R. 5122-16 are applicable to condom advertising. Applications for approval must be accompanied either by the certificate of conformity required by the regulations in force, or by proof that the CE marking provided for in article R. 5211-14 has been affixed.

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Article R5138-1 of the French Public Health Code

I. – The application for authorisation provided for in Article L. 5138-1 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by the legal representatives of the establishment by any means that enables receipt to be acknowledged, at least sixty days before the planned date of commencement of the activity. II. – It includes the following information : 1° Administrative information relating to…

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Article R5138-2-1 of the French Public Health Code

The declaration provided for in Article L. 5138-1 is sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the company to which the establishment belongs, by any means enabling receipt to be acknowledged. It includes the following information: 1° The name or corporate name and address of the company to which the establishment belongs and the address of the…

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Article R5138-2-2 of the French Public Health Code

The descriptive file provided for in Article L. 5138-1 and accompanying the declaration shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of acknowledging receipt. It includes the following information 1° Administrative information relating to the establishment where the activity of manufacturing, importing or distributing excipients is carried out, its internal organisation and, where applicable, its other activities and…

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