Slovenian Ministry of Health and the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) approved the stabilisation period during the first months of the implementation of Falsified Medicines Directive (FMD) with the aim to give stakeholders the possibility to gain more experience and resolve potential technical issues.
During this period, which ended on 30 September 2019, medicines in pharmacies and hospitals could have been dispensed to patients despite the alerts that occurred while scanning unique identifiers.
On Friday, 27 September 2019, JAZMP announced a partial extension of the stabilisation period until 30 November 2019.
During this extended period the following rules will apply:
• Pharmacists at the pharmacy or hospital pharmacy will be able to dispense medicines despite potential alerts, except in cases which indicate that the pack has already been dispensed in the same or at another location, or was marked as stolen, destroyed, a free sample, exported or repacked.
Exceptionally, the end-user will still be able to dispense a previously dispensed pack, but only if this exact end-user was also the one that marked the pack as dispensed by mistake on an earlier occasion.
• Wholesalers may no longer distribute medicines in the event of alerts of any type. The only exceptions are justified cases to prevent shortages in the supply of medicines that JAZMP was informed of in advance.
All other obligations stated in the Slovenian Medicines Act and the Delegated Regulation must be implemented by stakeholders. Meaning, marketing authorisation holders and manufacturers of medicinal products must apply safety features to medicinal products and upload related serialisation data to the national system and end-users must be connected to the system (NMVS), check the integrity of the anti-tempering device (ATD) and scan the unique identifier (UI) when dispensing the medicines. Any failure to comply with these obligations constitutes a violation of the applicable legislation.
Signed version of this document.
