In the Republic of Slovenia, the corporate donations of medicinal products are regulated by Articles 142 and 143 of the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 and 66/19) 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 of medicinal products are allowed for medicinal product with marketing authorisation or temporary marketing authorisation for the Republic of Slovenia, marketing authorisation for another EU Member State, or with marketing authorisation for a third country that has equivalent requirements as regards the quality, safety and efficacy of the medicinal products and has an annexed qualitative analysis report.
A donor shall notify JAZMP of any corporate donation of medicinal products. The donor of the medicinal product shall supply the medicinal product to all patients participating in the donation programme, with regard to which the benefits of treatment with this medicinal product must be documented, at least one year after the completion of the corporate donation programme.
The application should be submitted to JAZMP in written and electronic form. The latter should be sent by e-mail to: .
