[European Commission, Enterprise and Industry Directorate-General. Issue paper - Better regulation of pharmaceuticals: towards a simpler, clearer and more flexible framework on variations. Version 20 October 2006 [displayed 22 April 2010]. Available at http://ec.europa.eu/enterprise/pharmaceuticals/varreg/variations_issue_paper_20061020.pdf]Search in Google Scholar
[European Commission, Enterprise and Industry Directorate-General. Public consultation paper-implementation of the variations regulation (EC No 1234/2008) Article 4 (1) (b): Guidelines on the operation of the procedures laid down in Chapters II, III and IV of the Regulation 2009 [displayed 22 April 2010]. Available at http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2009/2009_03/41b/41b.pdf]Search in Google Scholar
[European Commission, Enterprise and Industry Directorate-General. Public consultation paper-implementation of the variations regulation (EC No 1234/2008) Article 4 (1) (a): Guideline on the details of the various categories of variations 2009 [displayed 22 April 2010]. Available at http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2009/2009_03/41a/41a.pdf]Search in Google Scholar
[Zakon o lijekovima [Medicinal products act, in Croatian]. Narodne novine 71/2007.]Search in Google Scholar
[Zakon o izmjenama i dopunama Zakona o lijekovima [Act on Amendments to the Medicinal Products Act, in Croatian]. Narodne novine 45/2009.]Search in Google Scholar
[Pravilnik o postupku i načinu davanja odobrenja za stavljanje gotovog lijeka u promet [Ordinance on the procedure and method for granting marketing authorization for medicinal products, in Croatian]. Narodne novine 113/2008.]Search in Google Scholar
[Pravilnik o posebnim uvjetima za stavljanje gotovog lijeka u promet u Republici Hrvatskoj koji ima odobrenje za stavljanje u promet u državama Europske unije [Ordinance on special conditions for placing medicinal products authorised in the Member States of the European Union on the market of the Republic of Croatia, in Croatian]. Narodne novine 10/2008.]Search in Google Scholar
[Zakon o lijekovima i medicinskim proizvodima [Act on medicinal products and medical devices, in Croatian]. Narodne novine 124/1997.]Search in Google Scholar
[Zakon o izmjenama Zakona o lijekovima i medicinskim proizvodima [Act on amendments to the act on medicinal products and medical devices, in Croatian]. Narodne novine 2001/53.]Search in Google Scholar
[Pravilnik o postupku i načinu davanja odobrenja za stavljanje u promet gotovog lijeka [Ordinance on the procedure and method for granting marketing authorization for medicinal products, in Croatian]. Narodne novine 143/1998.]Search in Google Scholar
[Zakon o lijekovima i medicinskim proizvodima [Act on medicinal products and medical devices, in Croatian]. Narodne novine 121/2003.]Search in Google Scholar
[Zakon o izmjenama i dopuni Zakona o lijekovima i medicinskim proizvodima [Act on amendments to the act on medicinal products and medical devices, in Croatian]. Narodne novine 177/2004.]Search in Google Scholar
[Pravilnik o posebnim uvjetima za stavljanje u promet gotovoga lijeka u Republici Hrvatskoj koji ima odobrenje za stavljanje u promet u državama Europske unije [Ordinance on special conditions for placing medicinal products authorised in the Member States of the European Union on the market of the Republic of Croatia, in Croatian]. Narodne novine 86/2004.]Search in Google Scholar
[Regulation (EC) No 1234/2008 of 24 November 2008 on concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. Official Journal of the European Union 2008;L334:7-24.]Search in Google Scholar
[Regulation (EC) No 1084/2003 of 3 June 2003 on concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State. Official Journal of the European Union 2003;L159:1-23.]Search in Google Scholar
[Regulation (EC) No 1085/2003 of 3 June 2003 on concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93. Official Journal of the European Union 2003;L159:24-45.]Search in Google Scholar
[Winterscheid S. Impact on new variation system on NCAs. In: International Conference "EU Regulatory Network-Challenges and Opportunities for Croatia"; 13-14 Nov 2008; Rijeka, Croatia. Unpublished lecture.]Search in Google Scholar
[Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union 2001;L311:67-128.]Search in Google Scholar
[Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Union 2001;L121:34-44.]Search in Google Scholar
[Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal 1993;L169.]Search in Google Scholar