title: Vaccine regulations in Croatia.
abstract: In this paper legal prerequisites for vaccine licensure in Croatia are discussed. The Croatian legislation concerning vaccine licensing, marketing authorisation and utilization is reviewed. The procedures for including a vaccine into the Mandatory Childhood Vaccination Programme are also discussed with focus on Human papillomavirus (HPV) vaccines. Non-obligatory vaccination recommendations are given when according to professional opinion; vaccination is beneficial for the vaccinee. There is little doubt that HPV vaccines should be recommended for preadolescent girls in Croatia. However, reaching a decision on its possible introduction into the Childhood Vaccination Programme will require careful consideration of the larger picture and a comparison of the cost-effectiveness of a mandatory vaccination against other competing public health priorities.
authors.affiliation: Department of Infectious Disease Epidemiology, Croatian Institute of Public Health, Zagreb, Croatia. bernard.kaic@hzjz.hr
authors.forename: Bernard
authors.initials: B
authors.lastname: Kaić
authors.forename: Ira
authors.initials: I
authors.lastname: Gjenero-Margan
authors.forename: Milka
authors.initials: M
authors.lastname: Brzović
authors.forename: Danijela
authors.initials: D
authors.lastname: Lakoseljac
authors.forename: Borislav
authors.initials: B
authors.lastname: Aleraj
authors.forename: Tatjana
authors.initials: T
authors.lastname: Nemeth-Blazić
authors.forename: Branko
authors.initials: B
authors.lastname: Kolarić
authors.forename: Viola
authors.initials: V
authors.lastname: Macolić-Sarinić
authors.forename: Aleksandar
authors.initials: A
authors.lastname: Simunović
authors.forename: Jasmina
authors.initials: J
authors.lastname: Pavlić
mesh_terms: D002648:Child; D003362:Cost-Benefit Analysis; D017523:Croatia; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007880:Legislation, Drug; D008004:Licensure / Q000331:legislation & jurisprudence; D053918:Papillomavirus Vaccines
chemical_list: D053918:Papillomavirus Vaccines