Vaccine regulations in Croatia.
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.
Kaić
Bernard
B
Department of Infectious Disease Epidemiology, Croatian Institute of Public Health, Zagreb, Croatia. bernard.kaic@hzjz.hr
Gjenero-Margan
Ira
I
Brzović
Milka
M
Lakoseljac
Danijela
D
Aleraj
Borislav
B
Nemeth-Blazić
Tatjana
T
Kolarić
Branko
B
Macolić-Sarinić
Viola
V
Simunović
Aleksandar
A
Pavlić
Jasmina
J
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
D053918:Papillomavirus Vaccines