In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other legislation, the Agency for Medicinal Products and Medical Devices (JAZMP) decides on the classification of the product on a case-by-case basis, taking into account:
- the qualitative and quantitative composition of the product;
- the intention and manner of its use;
- whether the product or its components have pharmacological, immunological or metabolic effects;
- whether the product is believed to have any direct or indirect therapeutic, preventive or diagnostic effects;
- a presentation of the product and its impact on the end user or customer;
- potential adverse effects and the related risks for the individual and for public health;
- the familiarity of the product to end users or customers;
- the latest scientific findings; and
- the guidelines of the European Union, which are published by JAZMP, and the national guidelines, which are prepared and published by JAZMP on its website.
An application for classification shall contain information on the qualitative and quantitative composition of the product and its safety, and a presentation of the product for end users or customers on the packaging, enclosed leaflets, brochures, websites, media, etc., as well as information on the status of the product in the Member States of the European Union.
NATIONAL GUIDELINES ON CLASSIFICATION
The national guidelines on the classification of borderline products with the list of herbs, vitamin and mineral limits and criteria for other substances are published at the following link: National guidelines (Slovenian version only).
EU GUIDELINES ON CLASSIFICATION
Linked to the EU guidelines.