Pharmacies & Hospitals
Public and hospital pharmacies play a key role in securing the authenticity of medicines dispensed to patients. According to the EU Directive 2011/62/EU, also called the Falsified Medicines Directive (FMD), the pharmacies in the Republic of Croatia must verify the authenticity of the medicines and decommission them (“deactivate”) from HOPAL’s repository before dispensation to patients.
If the unique identifier on the packaging does not match the repository data during the verification process, the system will display an alert for a particular pack. Detailed information about alert handling can be found in the Guidelines for EMVO and NMVO stakeholders.
HOPAL has conducted a process of connecting IT systems to pharmacies and other healthcare institutions that merge with repository, but they will not have any obligation to pay HOPAL compensation. However, they have to ensure technical prerequisites for the verification process by installing scanners for the unique identifiers and updating the software enabling the link with repository.
In case of any questions regarding the functionality, access options or operation of the national medicines verification repository system, please contact the Croatian Medicines Verification Organization via e-mail .
Extension of the transitional operational period of the Croatian Medicines Verification System until December 31st 2019.
The Ministry of Health issued a consent to extend the transitional operational period of the Croatian Medicines Verification System until December 31st, 2019, to facilitate an uninterrupted work of pharmacies and regular supply of medicines to patients.
During the transitional period, the pharmacies will verify the authenticity of the medicines in accordance with the applicable regulations but will deliver the medicine to the patient as per the existing procedure, irrespective of the triggered alerts. HOPAL will investigate the cause of alerts and all the potential incidents of falsification.
Please find the official letter of the Ministry of Health in the enclosed translated PDF document.