Entry in the register of importers of substances

The importers of substances with head offices in the Republic of Slovenia can start performing their activity after being entered in the register of importers of substances which is managed by the relevant authority.

The competent authority issues a certificate at the entry in the register under the previous paragraph.

The register of importers of substances contains the following information:

  •  the name of the business entity and permanent address, contact data (telephone, fax, e-mail)
  • and the list of substances that are imported.

The importer must, 60 days before starting the activity, notify the relevant authority on their activity with a written application that contains:

  •  evidence on fulfilling the conditions and
  • the list of substances that they intend to import.

The competent authority enters the importer of substances in the register of importers of substances on the basis of a positive opinion of the expert commission for fulfilling the conditions for the import of substances in 90 or 60 days from the date of the receipt of the complete application if they assess that the verification of the fulfilment of conditions is not necessary.

If the expert commission under the previous paragraph issues a negative opinion on the fulfilment of conditions for importing substances, the competent authority rejects the entry in the register of importers of substances by issuing a decision.

Business entities entered in the register of importers of substances may import substances.

These business entities include:

  •  the holders of the authorisation for manufacturing medicinal products,
  • the producers of substances and
  • wholesalers of substances.

 

 

Legal protection

  • Judicial remedy: Appeal
  • Competent authority: Ministry of Health

Legal basis/grounds

Last updated: 11. 02. 2016