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Showing 13831–13840 of 39711 articles for “Art. al. 3”
…2° The initials of the surname and first name of the patient for whom the prescription is intended; 3° The name of the medicinal product or, where applicable, its code name or international non-propri…
The certificates referred to in Article L. 5124-11 are issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These certificates are valid for three…
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
…lth establishment or in a health cooperation grouping authorised, respectively, under Articles L. 6132-2, as it stood prior to the publication of law no. 2009-879 of 21 July 2009 on hospital reform an…
…pean Union pursuant to 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 pr…
The parallel import authorisation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing a…
…al product used for the primary immunisation of young children or persons belonging to risk groups; 3° An immunological medicinal product used in public vaccination programmes. In the case of an immun…
…medicinal product, particularly with regard to the degree of dilution of each of its constituents; 3° The route of administration, for injectable homeopathic medicinal products.
I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum va…
…ement system as conditions of the marketing authorisation, in accordance with 1° of Article R. 5121-36-1.
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