Subsection 2: Conditions for authorising the apprenticeship programme

The authorisation of the learning programme covers the elements of the programme, the procedures for its implementation and the choice of operator. It is subject to the following conditions: 1° The existence of a benefit for a patient suffering from a medical condition whose medicinal treatment requires technical gestures, particularly in the case of chronic treatment; 2° The appropriateness of the programme to the requirements of learning the technical gesture,…

Only medicinal products which have obtained a marketing authorisation issued by the European Union in application of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency or a marketing authorisation issued by the Agence nationale de sécurité du médicament et…

The elements of the programme include in particular: 1° The name of the medicinal product, together with its international non-proprietary name; 2° Information essential for the appropriation of the technical procedures required by the treatment and for the proper use of the medicinal product; 3° A reminder of the patient’s rights with regard to the programme, including the prior information to be provided to the patient and the form for…