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Law on Medicines and Medical Devices.

Pays/Territoire
Serbie
Type du document
Législation
Date
2010
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Médicaments Autorisation/permis Santé des animaux Commerce intérieur Commerce international Transport/dépôt Procédures judiciaires/procédures administratives Collecte de données/déclarations Infractions/sanctions
Aire géographique
Europe, Europe et Asie Centrale
Entry into force notes
This Law enters into force eight days after its publication in the Official Gazette, except for the provisions of the article 101 that shall enter into force on 1 January 2012.
Résumé

This Law hereby stipulates the necessary conditions and procedures for the issuance of the marketing authorization, registration, production and other related activities (labelling, additional labelling, internal and international trade, transport and storage, small and big scale market rules and many other) all regarding the medicines and medical devices (human and animal-veterinary use).

Texte intégral
Serbe
Site web
www.vet.minpolj.gov.rs

Références - Législation

Implementé par

Regulation on clinical trials of medicinal products used exclusively in veterinary medicine.

Législation | Serbie | 2008

Mot clé: Médicaments, Santé des animaux, Recherche, Autorisation/permis, Procédures judiciaires/procédures administratives

Source: FAO, FAOLEX

Regulation on the procedure and conditions for obtaining a marketing authorization.

Législation | Serbie | 2005

Mot clé: Médicaments, Autorisation/permis, Commerce intérieur, Santé des animaux, Collecte de données/déclarations, Procédures judiciaires/procédures administratives

Source: FAO, FAOLEX

Regulation on the content of the marketing authorization for a medicinal product.

Législation | Serbie | 2005

Mot clé: Médicaments, Autorisation/permis, Procédures judiciaires/procédures administratives, Commerce intérieur, Santé des animaux

Source: FAO, FAOLEX

Regulation on the prohibition of certain substances for the treatment of animals intended for human consumption.

Législation | Serbie | 2009

Mot clé: Contrôle de qualité alimentaire/innocuité des produits alimentaires, Autorisation/permis, Résidus, Hormones/stéroïdes, Médicaments, Santé des animaux

Source: FAO, FAOLEX

Regulation on the content and labelling of external and internal drugs packages, on additional marking, as well as on drug leaflet.

Législation | Serbie | 2011

Mot clé: Médicaments, Santé des animaux

Source: FAO, FAOLEX

Regulation on the content and labelling of external and internal drugs packages, on additional marking, as well as on drug leaflet.

Législation | Serbie | 2008

Mot clé: Médicaments, Santé des animaux

Source: FAO, FAOLEX

Regulation on conditions for the production of drugs.

Législation | Serbie | 2008

Mot clé: Médicaments, Transformation/manutention, Éducation, Santé des animaux

Source: FAO, FAOLEX

Regulation on conditions for the wholesale of medicines and medical devices.

Législation | Serbie | 2008

Mot clé: Médicaments, Commerce intérieur, Autorisation/permis, Santé des animaux

Source: FAO, FAOLEX

Regulation on the content and method of marking of external and inner packaging of the drug, additional marking, as well contents of the medication instructions.

Législation | Serbie | 2011

Mot clé: Médicaments, Emballage/étiquetage, Autorisation/permis, Santé des animaux

Source: FAO, FAOLEX

Regulation on the conditions for wholesale of medicines and medical devices, data that entered in the register of issued licenses for wholesale of medicines and medical devices.

Législation | Serbie | 2012

Mot clé: Santé des animaux, Médicaments, Enregistrement, Collecte de données/déclarations, Commerce intérieur, Commerce international

Source: FAO, FAOLEX

Regulation on the registration of medical devices for use in veterinary medicine, on the marking and contents of the instructions for use, vigilance, as well as on advertising of medical devices for use in veterinary medicine.

Législation | Serbie | 2015

Mot clé: Médicaments, Santé des animaux, Enregistrement, Collecte de données/déclarations, Marquage/identificacion

Source: FAO, FAOLEX

Regulation on the manner of advertising of the medicinal product, or medical device.

Législation | Serbie | 2010

Mot clé: Médicaments, Commerce intérieur, Santé des animaux

Source: FAO, FAOLEX

Regulation on the quality control of medicinal products and medical devices.

Législation | Serbie | 2011

Mot clé: Médicaments, Recherche, Inspection, Santé des animaux

Source: FAO, FAOLEX

Regulation on the documentation and the method of import of medicines used in veterinary medicine which do not have a permit as medicinal products, as well as on the conditions, manner and procedure for importing medicinal products not registered in the Register of medical devices for use in veterinary medicine.

Législation | Serbie | 2015

Mot clé: Médicaments, Questions de procédures, Autorisation/permis, Commerce intérieur, Commerce international, Enregistrement, Santé des animaux

Source: FAO, FAOLEX

Regulation on the form and content of prescriptions for veterinary drugs, as well as the manner for issuing and prescribing of veterinary medicinal products.

Législation | Serbie | 2017

Mot clé: Médicaments, Procédures judiciaires/procédures administratives, Santé des animaux, Collecte de données/déclarations, Autorisation/permis

Source: FAO, FAOLEX

Regulation on the data to be entered in the register of issued licenses for the marketing of veterinary medicinal products and medical devices for use in veterinary medicine.

Législation | Serbie | 2014

Mot clé: Médicaments, Commerce intérieur, Commerce international, Enregistrement, Collecte de données/déclarations, Procédures judiciaires/procédures administratives, Santé des animaux

Source: FAO, FAOLEX

Regulation on specific rules for public procurement procedure.

Législation | Serbie | 2015

Mot clé: Commerce intérieur, Commerce international, Partenariats public-privé (PPP)

Source: FAO, FAOLEX

Amendé par

Law amending the Law on medicines and medical devices.

Législation | Serbie | 2012

Mot clé: Médicaments, Certification, Commerce international, Normes, Santé des animaux

Source: FAO, FAOLEX