Article R5121-81
For the application of the provisions of this section, army hospitals and the army blood transfusion centre are considered to be public health establishments and a blood transfusion establishment resp…
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Showing 10691–10700 of 36632 articles for “Art. al. 5”
For the application of the provisions of this section, army hospitals and the army blood transfusion centre are considered to be public health establishments and a blood transfusion establishment resp…
…du médicament et des produits de santé or on expiry of the period provided for in II of Article R. 5121-76-11, the Minister for Defence may grant the authorisation for use provided for in Article R.…
…obligation to monitor patients and collect information, or if the conditions set out in Article L. 5121-12-1 are no longer met, the Director General of the Agence nationale de sécurité du médicament…
…of any medicinal product or product is compulsory, unless the information referred to in article R. 5121-149 appears directly on the outer packaging or the immediate packaging. It must be written in F…
Without prejudice to the provisions of Article R. 5132-15, the labelling of the immediate packaging and, if available, the outer packaging of the preparations mentioned in 1° to 3° of Article L. 5121-…
In addition to the information provided for in articles R. 5121-138 and R. 5121-149, the labelling and package leaflet of traditional herbal medicinal products indicate that: 1° The product is a tradi…
…ling and, where applicable, the package leaflet of the medicinal products referred to in article L. 5121-13 must bear the following information only: 1° Homeopathic medicinal product in clearly visibl…
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…
…isation period. Renewal of the authorisation is granted under the conditions set out in Articles R. 5121-116 and R. 5121-123. If the Director General of the Agence nationale de sécurité du médicament…
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…
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