Adverse Drug Reactions Report for 2009
On 31 May 2010, the Agency for Medicinal Products and Medical Devices (HALMED) posted on its website the Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2009. The Report was drafted in accordance with the Medicinal Products Act (Official Gazette Nos. 71/07 and 45/09) and the accompanying Ordinance on Pharmacovigilance (Official Gazette No. 125/09), pursuant to which HALMED monitors adverse drug reactions (ADRs) in the Republic of Croatia that are related to the marketed medicinal products and the medicinal products in clinical trials, which healthcare professionals, marketing authorisation holders and clinical trial authorisation holders have an obligation to report.
As of the second half of 2009, ADR notifications can be sent to the HALMED by patients, too, as set forth in the new Ordinance on Pharmacovigilance (Official Gazette No 125/09).