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Act on Medicinal Products and Medicinal Devices.

Country/Territory
Croatia
Document type
Legislation
Date
2003
Source
FAO, FAOLEX
Subject
Environment gen.
Keyword
Data collection/reporting Environmental standards Monitoring Classification/declassification Standards Protection of environment
Geographical area
Europe, Europe and Central Asia, European Union Countries, Mediterranean, Southern Europe
Entry into force notes
This Act enters into force eight days after its publication in the Official Gazette, with the exclusion of the provisions of article 16 paragraph 1 and article 19 paragraphs 2 and 6 which shall apply from 1 January 2004.
Abstract

With a view to ensure efficacy, quality and safety of medicinal products and medical devices as products of special importance for the protection of human health, this Act lays down procedures for testing, placing on the market, manufacture, labelling, classification, distribution, pharmacovigilance, advertising/ information and supervision of medicinal products and medical devices, as well as quality control of medicinal products and conformity assessment of medical devices.

Full text
English
Website
www.hah.hr