In the Republic of Slovenia, the corporate donations of medicinal products are regulated by Article 143 of the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 with amendments, hereinafter: ZZdr-2) and fall within the competence of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereinafter: JAZMP). Corporate donation of medicinal products shall be deemed an intended and unconditional gift provided free of charge by a business entity (donor) to a health care service provider on the basis of its expressed and reasoned need for the medicinal product. The recipient of a corporate donation may be a health care service provider financed from public funds. The corporate donation of medicinal products is not permitted for medicinal products intended for compassionate use and these medicinal products shall not be subject to resale.
The corporate donation is allowed for a medicinal product with the authorisation in accordance with Art. 20 of the ZZdr-2 and for which other conditions of Article 143 of the ZZdr-2 are met.
A donor shall notify JAZMP of any corporate donation of medicinal products. The donor of the medicine must provide a statement in which they commit to supplying the medicine to all patients included in the donation program for as long as the treatment is documented to be beneficial for the patient or until public funding for the medicine is secured.
The application should be submitted to JAZMP in written and electronic form. The latter should be sent by e-mail to: .
