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Resolution No. 76 of the Council of the Eurasian Economic Commission validating Requirements for labelling of veterinary drugs.

Pays/Territoire
Kazakhstan
Type du document
Règlement
Date
2016
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Droits de propriété intellectuelle/brevets Médicaments Certification Santé des animaux
Aire géographique
Mer d’Aral, Asie, Mer Caspienne, Asie Centrale, CEI (Communauté des États indépendants), Europe et Asie Centrale, Nations en développement sans littoral, Asie du Nord
Résumé

This Resolution set out the rules for labelling on packages of veterinary drugs issued in circulation for the common market of medicines within the Eurasian Economic Union. Labeling of veterinary drugs shall be applied to packaging in the Russian language and in the presence of relevant requirements in the legislation of member states in the official language(s) of the Member State in whose territory veterinary drugs are sold. Additional use of other languages is permitted provided that full content of identical information is preserved. Labeling of veterinary drugs must not contradict or misrepresent the information contained in the registration dossier documents and must not contain advertising information. On the primary (inner) package of veterinary drug (except for a preparation), which is a packaged medicinal raw material of plant origin) shall be indicated the following information: (a) trade name of the veterinary drug; (b) international non-proprietary name (non patented name) (if any) or a common (grouping) name; (c) pharmaceutical form; (d) dosage and/or activity and/or concentration (if applicable) of active pharmaceutical substance (active pharmaceutical substances); (e) the quantity of the veterinary drug in the package; (f) method of application; (g) name or logo of the holder of the registration certificate or manufacturer (if necessary) of the veterinary drug (name or logo of the owner of the right registration certificate of a veterinary drug); (h) series number; (i) expiration date.

Texte intégral
Russe
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