The complexity of these systems stems from the autonomy granted to Member States under Article 168(7) of the Treaty on the Functioning of the European Union, which allows each country
to organize its own health insurance systems and allocate healthcare resources according to
its economic and health priorities.
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
Despite this autonomy, national decisions regarding the pricing and reimbursement of medicines must align with the principles of the free movement of goods as outlined in the Treaty and adhere to the procedural requirements established by the Transparency Directive 89/105/EEC. This directive mandates procedural obligations for Member States, ensuring pharmaceutical companies receive timely, motivated,
and appealable decisions regarding the pricing and reimbursement of their products, emphasizing minimal interference in Member States’ social security policies.
By relying on our expertise, pharmaceutical companies can effectively manage the dual challenges of national specificity and EU-wide regulatory compliance, ensuring successful market access and sustainable healthcare contributions.
With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.
Your trust is
our commitment!
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
Operation title: BILLEV FARMACIJA VZHOD digitalizacija
Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund”.
Regulatory Affairs
Pharmacovigilance
Medical Consultancy
Quality/GxP
Digital Consultancy
