Case report
Vaccine Regulations in Croatia
Bernard Kaić
Ira Gjenero-Margan
Milka Brzović
Danijela Lakošeljac
Borislav Aleraj
Tatjana Nemeth-Blažić
Branko Kolarić
Viola Macolić-Šarinić
Aleksandar Šimunović
Jasmina Pavlić
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.
Keywords
Hrčak ID:
27453
URI
Publication date:
13.4.2007.
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