In Croatia, the investment project NPOO C5.1. R4-I4 “Development of a medicines shortage monitoring and prevention system in Croatia” from the National Recovery and Resilience Plan (NRRP) 2021–2026 is being implemented. At the same time, the Ministry of Health announced amendments to the Medicines Act and the introduction of a new ordinance that will regulate the obligations of regular submission of data on medicines consumption, supplies, and shortages.

The reporting entities were not included in the working group for this project, which puts them at a disadvantage because they were prevented from actively participating in the dialog and contributing before the beginning of the public consultation process. There are nearly 10,000 medicinal products on the market in Croatia. The volume of data and the frequency of reporting for all reporting entities pose a significant challenge in terms of process adaptation, technical requirements, data access within the company, and the human resources needed for data implementation and oversight.

AmCham believes that the following recommendations should be implemented to improve the project:

1. Including all stakeholders in the drafting of the regulation

2. Equalizing the obligations of all participants in the pharmaceutical supply chain

3. Reducing the frequency of reporting

4. Limiting the list of critical medicines

5. Application of Multiwinning tenders

AmCham's position paper is available here.