Entry in the register of manufacturers of active substances

The manufacturer of active substances with head office in the Republic of Slovenia can start performing their activity after being entered in the register of manufacturers of active substances, managed by the relevant authority.

The register of manufacturers of active substances contains the following information:

  •  the name of the business entity and permanent address, contact data (telephone, fax, e-mail) and
  • the manufactured active substance.

The competent authority issues a certificate upon entry into the register under the first paragraph.

The manufacturers of active substances notify their activity at the relevant authority at least 60 days before starting to perform the activity, i.e. on a written application that contains evidence on fulfilling the prescribed conditions and the list of active substances they intend to manufacture.

The competent authority enters the manufacturer of active substances in the register of manufacturers of active substances on the basis of a positive opinion of the expert commission for fulfilling the conditions for the manufacture of active substances in 90 or 60 days from the date of 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 manufacturing active substances, the competent authority rejects the entry in the register of active substances by issuing a decision.

Legal protection

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

Legal basis/grounds

Last updated: 11. 02. 2016