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

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

Open Access
|Sep 2010

References

  1. 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
  2. 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
  3. 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
  4. Zakon o lijekovima [Medicinal products act, in Croatian]. Narodne novine 71/2007.
  5. Zakon o izmjenama i dopunama Zakona o lijekovima [Act on Amendments to the Medicinal Products Act, in Croatian]. Narodne novine 45/2009.
  6. 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.
  7. 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.
  8. Zakon o lijekovima i medicinskim proizvodima [Act on medicinal products and medical devices, in Croatian]. Narodne novine 124/1997.
  9. 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.
  10. 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.
  11. Zakon o lijekovima i medicinskim proizvodima [Act on medicinal products and medical devices, in Croatian]. Narodne novine 121/2003.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal 1993;L169.
DOI: https://doi.org/10.2478/10004-1254-61-2010-2015 | Journal eISSN: 1848-6312 | Journal ISSN: 0004-1254
Language: English, Croatian, Slovenian
Page range: 311 - 322
Published on: Sep 22, 2010
Published by: Institute for Medical Research and Occupational Health
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2010 Adrijana Martinac, Siniša Tomić, Mirna Šimičić, published by Institute for Medical Research and Occupational Health
This work is licensed under the Creative Commons License.

Volume 61 (2010): Issue 3 (September 2010)