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Law on Medicines and Medical Devices.

Country/Territory
Serbia
Document type
Legislation
Date
2010
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Drugs Authorization/permit Animal health Internal trade International trade Transport/storage Legal proceedings/administrative proceedings Data collection/reporting Offences/penalties
Geographical area
Europe, Europe and Central Asia
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.
Abstract

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).

Full text
Serbian
Website
www.vet.minpolj.gov.rs

References - Legislation

Implemented by

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

Legislation | Serbia | 2008

Keyword: Drugs, Animal health, Research, Authorization/permit, Legal proceedings/administrative proceedings

Source: FAO, FAOLEX

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

Legislation | Serbia | 2005

Keyword: Drugs, Authorization/permit, Internal trade, Animal health, Data collection/reporting, Legal proceedings/administrative proceedings

Source: FAO, FAOLEX

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

Legislation | Serbia | 2005

Keyword: Drugs, Authorization/permit, Legal proceedings/administrative proceedings, Internal trade, Animal health

Source: FAO, FAOLEX

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

Legislation | Serbia | 2009

Keyword: Food quality control/food safety, Authorization/permit, Residues, Hormones/steroids, Drugs, Animal health

Source: FAO, FAOLEX

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

Legislation | Serbia | 2011

Keyword: Drugs, Animal health

Source: FAO, FAOLEX

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

Legislation | Serbia | 2008

Keyword: Drugs, Animal health

Source: FAO, FAOLEX

Regulation on conditions for the production of drugs.

Legislation | Serbia | 2008

Keyword: Drugs, Processing/handling, Education, Animal health

Source: FAO, FAOLEX

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

Legislation | Serbia | 2008

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

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.

Legislation | Serbia | 2011

Keyword: Drugs, Packaging/labelling, Authorization/permit, Animal health

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.

Legislation | Serbia | 2012

Keyword: Animal health, Drugs, Registration, Data collection/reporting, Internal trade, International trade

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.

Legislation | Serbia | 2015

Keyword: Drugs, Animal health, Registration, Data collection/reporting, Marking/identification

Source: FAO, FAOLEX

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

Legislation | Serbia | 2010

Keyword: Drugs, Internal trade, Animal health

Source: FAO, FAOLEX

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

Legislation | Serbia | 2011

Keyword: Drugs, Research, Inspection, Animal health

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.

Legislation | Serbia | 2015

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

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.

Legislation | Serbia | 2017

Keyword: Drugs, Legal proceedings/administrative proceedings, Animal health, Data collection/reporting, Authorization/permit

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.

Legislation | Serbia | 2014

Keyword: Drugs, Internal trade, International trade, Registration, Data collection/reporting, Legal proceedings/administrative proceedings, Animal health

Source: FAO, FAOLEX

Regulation on specific rules for public procurement procedure.

Legislation | Serbia | 2015

Keyword: Internal trade, International trade, Public private partnership (PPP)

Source: FAO, FAOLEX

Amended by

Law amending the Law on medicines and medical devices.

Legislation | Serbia | 2012

Keyword: Drugs, Certification, International trade, Standards, Animal health

Source: FAO, FAOLEX