Definicija: dokument, ki ga mora pri Javni agenciji za zdravila in medicinske pripomočke pridobiti vsako zdravilo, ki ga želi nekdo umestiti na slovenski trg
Vir - besedilo: Zakon o zdravilih; Ur. l. RS, št. 31/2006
Vir - besedilo: 32003L0063 Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use Module 1
Vir - besedilo: 32001L0083 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
Vir - besedilo: 32001L0083 Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini
Vir - besedilo: 32003L0063 Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use Table of contents
Vir - besedilo: 32003L0063 Direktiva Komisije 2003/63/ES z dne 25. junija 2003 o spremembi Direktive 2001/83/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v humani medicini Pregled vsebine
Vir - besedilo: 32003L0063 Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
Vir - besedilo: 32003L0063 Direktiva Komisije 2003/63/ES z dne 25. junija 2003 o spremembi Direktive 2001/83/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v humani medicini
6enCOMMISSION REGULATION (EC) No. 1069/98 of 26 May 1998 amending Regulation (EC) No. 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No. 2309/93zdravje, medicina