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Showing 751–760 of 60748 articles for “Art. CE 11-5-2021 n° 440044 and 440045”
Except where there are public health reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an au…
…1° For medicinal products imported for research involving the human person, an acknowledgement of receipt of the application sent to the Agence nationale de sécurité du médicament et des produits de s…
…er from the proprietary medicinal product which has already obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than…
…ical to that of the proprietary medicinal product which has obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsib…
The application for an import authorisation must be sent by any means capable of providing a date certain and must indicate : 1° The name or business name and address of the natural or legal person re…
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…
…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 an imported medicinal product or a c…
…tary 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 or party to the Agreement on…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may request the applicant to provide additional information necessary for the examination of the applica…
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