MEDICINAL PRODUCTS FOR HUMAN USE

This part of the website provides access to information relating to medicinal products for human use and their professional and regulatory background.

Proper regulation of medicinal products for human use is an important part of efforts to protect public health. In the Republic of Slovenia, medicinal products are regulated by the Medicinal Products Act (Official Gazette of the Republic of Slovenia, No 17/2014 and No 66/2019, hereinafter: the Act) and the related implementing regulations, and they fall under the competence of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP).

In accordance with the legislation relating to medicinal products, a medicinal product is any substance or a combination of substances presented as having properties for treating or preventing disease in human beings. A medicinal product is also any substance or a combination of substances that may be used in humans in order to establish a diagnosis or to restore, correct or modify physiological functions by exerting pharmacological, immunological or metabolic action.

Provides access to the regulatory information on the medicinal products for human use

Provides access to the database and other lists in the field of medicinal products for human use.

Provides access to the regulatory information on the medicinal products for human use.

Information on bilogical medicinal products and biosimilars

Illicit drugs are plants or substances of natural or artificial origin

Information related to pharmacovigilance and adverse drug reactions

Information in clinical trials and compassionate use of medicinal products

Pricing of Medicinal Products is regulated by Medicinal Products Act

Information on fees

Information on corporate donations of medicinal products

This part of the website provides access to the forms

HTA

Information on Health Technology Assessment

Product classification

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