New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.
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.
Martinac
Adrijana Ilić
AI
Agency for Medicinal Products and Medical Devices, Zagreb. adrijana.ilic@halmed.hr
Tomić
Sinisa
S
Simicić
Mirna
M
D005062:European Union; D007880:Legislation, Drug; D040541:Marketing / Q000331:legislation & jurisprudence*; D004364:Pharmaceutical Preparations / Q000592:standards*; D012449:Safety
D004364:Pharmaceutical Preparations