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Veterinary Medicinal Products Regulations, 2004 (L.N. 469 of 2004).

Country/Territory
Malta
Document type
Regulation
Date
2004
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Authorization/permit Data collection/reporting Access-to-information Inspection Internal trade International trade Offences/penalties
Geographical area
Europe, EUROPE AND CENTRAL ASIA, European Union Countries, Mediterranean, Southern Europe
Abstract

In compliance with the European Community code relating to veterinary medicinal products laid down in Directive 2001/82/EC, the present Regulations establish particular provisions applicable to veterinary medicinal products destined to be placed on the market in the form of medicinal products, readymade veterinary medicinal products or premixes for medicated feedingstuffs. Title III (regs. 5-37) deals with marketing, for which an authorization issued by the Veterinary Services is compulsory. Title IV (regs. 38-50) concerns manufacture and imports. Title V (regs. 51-57) deals with labelling and package insert. Title VI (regs. 58-64) applies to the possession, wholesale distribution and dispensing of veterinary medicinal products. Title VII (regs. 65-71) provides for the setting up of a pharmocovigilance system. Title VIII (regs. 72-79) regards the inspections to be carried out by the Veterinary Services with a view to ensuring compliance with these Regulations, and sets out the sanctions to be applied in case of infringement. The Schedule attached concerns the requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal products.

Full text
English
Website
www.doi.gov.mt

References - Legislation

Implements

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

Legislation | 2001

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

Source: FAO, FAOLEX

Implemented by

Veterinary Medicinal Products (Amendment) (No. 2) Regulations (L.N. 360 of 2009).

Legislation | Malta | 2009

Keyword: Drugs, Animal health, Inspection

Source: FAO, FAOLEX

Amended by

Veterinary Medicinal Products (Amendment) Regulations, 2006 (L.N. 82 of 2006).

Legislation | Malta | 2006

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

Source: FAO, FAOLEX

Veterinary Medicinal Products (Amendment) (No. 2) Regulations, 2009 (L.N. 360 of 2009).

Legislation | Malta | 2009

Keyword: Drugs, Animal health, Standards, Inspection

Source: FAO, FAOLEX

Veterinary Medicinal Products (Amendment) Regulations, 2009 (L.N. 23 of 2009).

Legislation | Malta | 2009

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

Source: FAO, FAOLEX

Veterinary Medicinal Products (Amendment No. 2) Regulations, 2021.

Legislation | Malta | 2021

Keyword: Animal health, Drugs, Offences/penalties

Source: FAO, FAOLEX

Veterinary Medicinal Products (Amendment) Regulations, 2021 (L.N. 179 of 2021).

Legislation | Malta | 2021

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

Source: FAO, FAOLEX