Regulation No. 26 of 2012 of Minister of Social Affairs of Estonia on Procedure for providing safety information about medicinal products, for calculating the fees charged for the safety and quality monitoring of medicinal products and for the payment of such fees

Sujet

Bétail

Mot clé

Médicaments Santé publique Royalties/redevances Monitorage Emballage/étiquetage Questions de procédures Santé des animaux Aliments pour animaux

Aire géographique

Europe, Europe et Asie Centrale, Pays de l'Union Européenne, Europe du Nord

Résumé

This regulation establishes the procedure for providing safety information about medicinal products, for calculating the fees charged for the safety and quality monitoring of medicinal products and for the payment of such fees. The physician, dentist, veterinarian, nurse, midwife or user of a medicinal product informs the State Agency of Medicines of an adverse reaction to a medicinal product, using the electronic form of the adverse reaction report or a paper report.

Texte intégral

Estonien/Anglais

Site web

www.riigiteataja.ee

Références - Législation

Implemente

Directive 2004/28/EC of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

Législation | Union européenne | 2004

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

Source: FAO, FAOLEX

Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.

Législation | Union européenne | 2001

Mot clé: Législation de base, Santé des animaux, Médicaments, Autorisation/permis, Collecte de données/déclarations, Accès-à-l'information, Inspection, Commerce intérieur, Commerce international, Infractions/sanctions

Source: FAO, FAOLEX

Commission Directive 2009/9/EC amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use.

Législation | Union européenne | 2009

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

Source: FAO, FAOLEX

Medicinal Products Act (2004)

Législation | Estonie | 2004 (2020)

Mot clé: Médicaments, Autorisation/permis, Santé publique, Santé des animaux, Aliments pour animaux, Infractions/sanctions, Emballage/étiquetage, Transport/dépôt, Commerce intérieur, Enregistrement

Source: FAO, FAOLEX