<abstract xml:lang="en" xmlns="http://www.w3.org/1999/xhtml"><p>Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.</p></abstract>

Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

Agency for Medicinal Products and Medical Devices, Zagreb

Jadran Galenski Laboratorij d.d., Rijeka, Croatia

Archives of Industrial Hygiene and Toxicology

Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and...

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

Published Online: Sep 22, 2010

Page range: 311 - 322

DOI: https://doi.org/10.2478/10004-1254-61-2010-2015

Keywords
djelotvornost, dokumentacija o lijeku, kakvoća, sigurnost, Zakon o lijekovima

This content is open access.

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

Published Online: Sep 22, 2010

Page range: 311 - 322

DOI: https://doi.org/10.2478/10004-1254-61-2010-2015

Keywordsdjelotvornost, dokumentacija o lijeku, kakvoća, sigurnost, Zakon o lijekovima

This content is open access.

Keywords
djelotvornost, dokumentacija o lijeku, kakvoća, sigurnost, Zakon o lijekovima