Agency for Medicinal Products and Medical Devices, Zagreb.
Arh Hig Rada Toksikol. 2010 Sep;61(3):311-22. doi: 10.2478/10004-1254-61-2010-2015.
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.
对药品文件所作的变更不得影响产品的质量、疗效和安全性。克罗地亚的《药品法》及其配套条例在很大程度上与欧盟的规定保持一致。欧盟现已尝试通过新法规简化变更问题，对克罗地亚和欧盟在某些类型变更的定义和处理方法上造成差异。这些差异可能会阻碍克罗地亚变更批准程序，特别是对于已在欧盟获得批准的药品。修订已经在欧盟获得授权的克罗地亚药品条例是保持克罗地亚监管系统效率的一种方式。
