title: Generic Medicines in Croatia--Regulatory Aspects and Statistics.
abstract: A generic medicine is an equivalent of an originator pharmaceutical product. It contains the same active substance as, is "essentially similar" to, and is therefore interchangeable with, the originator product. The objective of this study was to determine the share of generic medicines of the total received marketing authorization applications in Croatia, and the specificities in the approval of generic medicines with regard to assessments of their quality documentation. We collected the information from the Agency's medicinal products databases. Absolute numbers are shown for the applications for the authorizations of medicines in total and generics in particular in the period from 2005-2009. Data were analyzed using descriptive statistics. The annual number of marketing authorization applications for generic medicines received in Croatia increased from 148 applications in 2005 to 276 applications in 2009. In the period from 2005-2009, the number of applications for the approval of generic medicines accounted for 55% of all submitted applications. More than five generic medicines were approved for the following active compounds: amlodipine, lisinopril, atorvastatin, tamsulosin and omeprazole. In the following years, the number of applications from international manufacturers stagnated, while the number of applications by local manufacturers is on a steady climb, with the exception of 2008. From 2005-2009, an almost continual increase in the number of applications for the approval of generic medicines is evident. The largest number of generic medicines was approved for generic medicines intended for the treatment of cardiovascular disease (amlodipine, lisinopril, atorvastatin). A continual increase of applications from local manufacturers has been recorded. In the approval of these medicines, it is very important to develop a uniform approach to assessing the quality of each medicine, in order to guarantee a high quality product for the patient.
authors.forename: Selvira
authors.initials: S
authors.lastname: Zulfikari
authors.forename: Anita Filipović
authors.initials: AF
authors.lastname: Sučić
authors.forename: Koraljka
authors.initials: K
authors.lastname: Meštrović
authors.forename: Mirjana Perić
authors.initials: MP
authors.lastname: Barbarić
authors.forename: Vesna
authors.initials: V
authors.lastname: Mandarić
authors.forename: Nataša
authors.initials: N
authors.lastname: Zorić
authors.forename: Siniša
authors.initials: S
authors.lastname: Tomić
mesh_terms: D017523:Croatia; D003627:Data Interpretation, Statistical; D004335:Drug and Narcotic Control; D016568:Drugs, Generic; D006801:Humans
chemical_list: D016568:Drugs, Generic