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Law on Medicines and Medical Devices.

Country
Serbia
Type of law
Legislation
Source
FAO , FAOLEX
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).
This Law is divided into IX Chapters and 232 articles, including the offences and related penalties.
Attached files
http://faolex.fao.org/docs/pdf/srb162201.pdf
Web site
http://www.vet.minpolj.gov.rs
Date of text
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.
Repealed
No
Publication reference
(Official Gazette 84/2004)
Source language

English

Legislation Amendment
No
Original title
Закон о лековима и медицинским средствима.
Amended by
Law amending the Law on medicines and medical devices.
Implemented by
Regulation on the form and content of prescriptions for veterinary drugs, as well as the manner for issuing and prescribing of veterinary medicinal products.
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.
Regulation on specific rules for public procurement procedure.
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.
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.
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.
Regulation on the content and labelling of external and internal drugs packages, on additional marking, as well as on drug leaflet.
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.
Regulation on the quality control of medicinal products and medical devices.
Regulation on the manner of advertising of the medicinal product, or medical device.
Regulation on the prohibition of certain substances for the treatment of animals intended for human consumption.
Regulation on conditions for the production of drugs.
Regulation on conditions for the wholesale of medicines and medical devices.
Regulation on the content and labelling of external and internal drugs packages, on additional marking, as well as on drug leaflet.
Regulation on clinical trials of medicinal products used exclusively in veterinary medicine.
Regulation on the procedure and conditions for obtaining a marketing authorization.
Regulation on the content of the marketing authorization for a medicinal product.