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

Country
Serbia
Type of law
Regulation
Source
FAO , FAOLEX
Abstract
This Regulation defines the necessary content of the request (administrative and technical requirements), the procedure and conditions for obtaining the authorization for marketing of medicinal products (including the veterinary medicines), and further defines various related issues such as data collection, rules for the renewal of the previously obtained authorization/license/permit.
Attached files
http://faolex.fao.org/docs/pdf/srb162358.pdf
Web site
http://www.vet.minpolj.gov.rs
Date of text
Entry into force notes
This Regulation enters into force eight days after its publication in the Official Gazette.
Repealed
Yes
Publication reference
(Official Gazette 93/2005)
Source language

English

Legislation Amendment
No
Original title
Правилник о поступку и условима за добијање дозволе за стављање лека у промет.
Implements
Law on Medicines and Medical Devices.
Repealed by
Regulation on the content of the marketing authorization.