Article R5121-116
…of the aforementioned Directive; 3° Subject to the provisions of Articles R. 5121-117 to R. 5121-119, the contents of the packaging in terms of weight, volume or number of dosage units, the classific…
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Showing 2411–2420 of 26600 articles for “Art. Cass. com. 9 octobre 2012 n° 11-21528”
…of the aforementioned Directive; 3° Subject to the provisions of Articles R. 5121-117 to R. 5121-119, the contents of the packaging in terms of weight, volume or number of dosage units, the classific…
The proprietary medicinal product for which parallel import authorisation is sought may differ from the proprietary medicinal product which has already obtained marketing authorisation in France, as r…
…changing the packaging, in addition to the information provided for in e of 1° of Article R. 5121-149; 2° The full qualitative composition of excipients where this differs from that of the proprietary…
The labelling and outer packaging of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained ma…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the d…
…authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate access authorisation under II of article L. 5121-12-1 granted for…
The importation of a proprietary medicinal product constitutes a parallel import with a view to placing it on the market in France: 1° Which comes from another Member State of the European Community o…
When an internal-use pharmacy is no longer able to carry out one or more of its tasks and activities, it may entrust other internal-use pharmacies with their implementation. The competent administrati…
The provisions of section 4 of chapter IV of title II of book IV of the fifth part of the labour code (regulatory part) are applicable to Mayotte, subject to the following adaptations: 1° The amount o…
…ticle D. 5427-4 in accordance with the terms and conditions set out in Decree no. 55-763 of 26 May 1955.
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