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Showing 11–20 of 47 articles for “Art. 1161”
…d by the company marketing the medicinal product; 6° The follow-up report referred to in article R. 1161-25, in the event of an application for renewal of authorisation; 7° Authorisation from the Comm…
…rder to provide or coordinate therapeutic patient education, the persons referred to in articles D. 1161-1 and R. 1161-3 must have the following skills: 1° Technical skills enabling them to provide pa…
A patient may or may not accept to take part in a learning programme defined in article L. 1161-5, which is proposed to him by the doctor prescribing the medicinal treatment. This acceptance must be g…
The declaration referred to in Article L. 1161-2 ceases to have effect if :1° The programme is not implemented within twelve months of it taking effect ;2° The programme is no longer implemented for s…
Decisions to authorise or withdraw authorisation taken in application of Article L. 1161-5 are published on the Agency's website. Decisions to withdraw programme authorisation may be accompanied by an…
The application for authorisation referred to in Article L. 1161-5 is sent by the company exploiting the medicinal product to the Director General of the Agence nationale de sécurité du médicament et…
…of the guarantees of independence that it offers, in particular those mentioned in 1° of article R. 1161-24, its skills and the human and material resources it has available to carry out the tasks inv…
…ationale de sécurité du médicament et des produits de santé of the report referred to in Article R. 1161-25.
…If a declared programme does not comply with one or more of the obligations set out in articles L. 1161-1 to L. 1161-4 and R. 1161-3, the Director General of the Regional Health Agency will inform th…
…on are determined by decree.Within the framework of the programmes or actions defined in article L. 1161-3, any direct contact between a patient and their family and a company involved in the exploita…
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