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Showing 31–40 of 47 articles for “Art. 1161”
Any change to any of the elements of the application for authorisation of the programme will give rise to a new authorisation, issued under the same conditions as the initial authorisation.
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 Mar…
Operators must comply with all the following obligations: 1° The salaried director of the operator and the healthcare professionals in charge of carrying out the operations provided for in the program…
I. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) decides on the application…
The learning programmes are designed to be consistent with the public health initiatives carried out by the health authorities, health insurance organisations and health establishments, where these ex…
Information on learning programmes must be dissociated from any promotional communication relating to the medicinal product covered by the programme and may not be the subject of any direct communicat…
The company informs doctors of the existence of learning programmes. The doctor prescribing the treatment may suggest that his patients who could benefit from this programme take part in it. If the pa…
Learning programmes are designed to improve patient care and the correct use of medicines. They are designed to encourage and monitor the appropriation of technical procedures carried out by patients…
The company exploiting the medicinal product produces a follow-up report at the end of each programme or at the latest when it is renewed. The report is sent to the treating doctor, the prescribing do…
The learning programme is made up of elements intended for the patient, the healthcare professional, the doctor or pharmacist in charge of the programme, the treating doctor and the prescribing doctor…
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