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

Subject

Livestock

Keyword

Drugs Public health Royalties/fees Monitoring Packaging/labelling Procedural matters Animal health Animal feed/feedstuffs

Geographical area

Europe, Europe and Central Asia, European Union Countries, Northern Europe

Abstract

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.

Full text

English/Estonian

Website

www.riigiteataja.ee

References - Legislation

Implements

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.

Legislation | European Union | 2004

Keyword: Animal health, Drugs, Authorization/permit, Internal trade, International trade

Source: FAO, FAOLEX

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

Legislation | European Union | 2001

Keyword: Basic legislation, Animal health, Drugs, Authorization/permit, Data collection/reporting, Access-to-information, Inspection, Internal trade, International trade, Offences/penalties

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.

Legislation | European Union | 2009

Keyword: Animal health, Drugs, Authorization/permit, Internal trade, International trade, Animal feed/feedstuffs

Source: FAO, FAOLEX

Medicinal Products Act (2004)

Legislation | Estonia | 2004 (2020)

Keyword: Drugs, Authorization/permit, Public health, Animal health, Animal feed/feedstuffs, Offences/penalties, Packaging/labelling, Transport/storage, Internal trade, Registration

Source: FAO, FAOLEX