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Law on Medicines and Medical Devices.

País/Territorio
Serbia
Tipo de documento
Legislación
Fecha
2010
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Medicamentos Autorización/permiso Sanidad animal Comercio interior Comercio internacional Transporte/depósito Procedimientos judiciales/procedimientos administrativos Recopilación de datos/informes Infracciones/sanciones
Área geográphica
Europa, Europa y 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.
Resumen

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).

Texto completo
Serbio
Página web
www.vet.minpolj.gov.rs

Referencias - Legislación

Implementado por

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

Legislación | Serbia | 2008

Palabra clave: Medicamentos, Sanidad animal, Investigación, Autorización/permiso, Procedimientos judiciales/procedimientos administrativos

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2005

Palabra clave: Medicamentos, Autorización/permiso, Comercio interior, Sanidad animal, Recopilación de datos/informes, Procedimientos judiciales/procedimientos administrativos

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2005

Palabra clave: Medicamentos, Autorización/permiso, Procedimientos judiciales/procedimientos administrativos, Comercio interior, Sanidad animal

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2009

Palabra clave: Control de calidad de los alimentos/inocuidad de los alimentos, Autorización/permiso, Residuos, Hormonas/esteroides, Medicamentos, Sanidad animal

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2011

Palabra clave: Medicamentos, Sanidad animal

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2008

Palabra clave: Medicamentos, Sanidad animal

Fuente: FAO, FAOLEX

Regulation on conditions for the production of drugs.

Legislación | Serbia | 2008

Palabra clave: Medicamentos, Procesamiento/manipulación, Educación, Sanidad animal

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2008

Palabra clave: Medicamentos, Comercio interior, Autorización/permiso, Sanidad animal

Fuente: 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.

Legislación | Serbia | 2011

Palabra clave: Medicamentos, Envasado/etiquetado, Autorización/permiso, Sanidad animal

Fuente: 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.

Legislación | Serbia | 2012

Palabra clave: Sanidad animal, Medicamentos, Registro, Recopilación de datos/informes, Comercio interior, Comercio internacional

Fuente: 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.

Legislación | Serbia | 2015

Palabra clave: Medicamentos, Sanidad animal, Registro, Recopilación de datos/informes, Marcado/identificación

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2010

Palabra clave: Medicamentos, Comercio interior, Sanidad animal

Fuente: FAO, FAOLEX

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

Legislación | Serbia | 2011

Palabra clave: Medicamentos, Investigación, Inspección, Sanidad animal

Fuente: 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.

Legislación | Serbia | 2015

Palabra clave: Medicamentos, Cuestiones de procedimiento, Autorización/permiso, Comercio interior, Comercio internacional, Registro, Sanidad animal

Fuente: 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.

Legislación | Serbia | 2017

Palabra clave: Medicamentos, Procedimientos judiciales/procedimientos administrativos, Sanidad animal, Recopilación de datos/informes, Autorización/permiso

Fuente: 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.

Legislación | Serbia | 2014

Palabra clave: Medicamentos, Comercio interior, Comercio internacional, Registro, Recopilación de datos/informes, Procedimientos judiciales/procedimientos administrativos, Sanidad animal

Fuente: FAO, FAOLEX

Regulation on specific rules for public procurement procedure.

Legislación | Serbia | 2015

Palabra clave: Comercio interior, Comercio internacional, Participación público privada (PPP)

Fuente: FAO, FAOLEX

Enmendado porr

Law amending the Law on medicines and medical devices.

Legislación | Serbia | 2012

Palabra clave: Medicamentos, Certificación, Comercio internacional, Normas, Sanidad animal

Fuente: FAO, FAOLEX