The entry in the register of substances wholesalers
The wholesaler of substances with its head office in the Republic of Slovenia can start performing their activity after being entered in the register of wholesalers of substances, managed by the relevant authority.
The competent authority issues a certificate at the entry in the register.
The register of active substances wholesalers contains the following data:
- name of business entity and permanent address, contact data (telephone, fax and e-mail);
- the list of substances sold by the wholesaler.
60 days before starting the activity, the substances wholesaler must notify the relevant authority on the activity by submitting a written application that contains:
- evidence on fulfilling the prescribed conditions
- and the list of substances that will be sold.
The competent authority enters the substances wholesaler in the register of substances wholesalers on the basis of a positive opinion of the expert commission for fulfilling the conditions for the manufacture 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 fulfilling the conditions for the wholesale of substances, the competent authority issues a decision rejecting the entry in the register.
Conditions and evidence
- Judicial remedy: Appeal
- Competent authority: Ministry of Health