Information regarding parallel import and parallel distribution of medicinal products

Entry shall mean a wholesale of a medicinal product from another EU Member State in the territory of the Republic of Slovenia. Import shall mean wholesale of a medicinal product from third countries into the territory of the Republic of Slovenia.

According to Medicinal Products Act (Uradni list RS, no. 17/2014), the applicant for authorisation for entry of medicinal products may be a wholesaler, whereas for import of medicinal products it may be a person that meets the conditions for import of medicinal products (medicinal product manufacturing authorisation with authorisation of wholesale distribution of medicinal products).

The entry and import are free for medicinal products within the first paragraph of the 116th article of the Medicinal Products Act (Uradni list RS, no. 17/2014). However, the entry and import that do not have the marketing authorization form this paragraf are only allowed for medicinal products within third paragraph of the 20th article of the Medicinal Products Act.

More detailed conditions and procedure of entry and import of medicinal products are defined in the Rules on the conditions, manner and procedure for entry and import of certain groups of medicinal products for veterinary medicinal products (Official Gazette of RS, no. 90/2011).

Entry or import is also free for medicinal products which are entered or imported for the purpose of being marketed in other countries, and which will not be sold in the Republic of Slovenia, provided that the entry or import is carried out on the basis and within the context of appropriate authorisation for manufacturing or wholesale of medicinal products.