Distribution, Manufacturing and Inspection

Application Procedure for Wholesalers/Brokers Seated Outside Croatia, in the EU

Application procedure for natural or legal persons with the seat outside of the Republic of Croatia that comply with the requirements in another EU Member State for wholesale or brokerage, about the beginning of their operations in the Republic of Croatia

Under Art. 121 of the Medicinal Products Act (Official Gazette, No. 76/13) natural and legal persons with the seat outside the Republic of Croatia, that comply with the requirements for wholesale or brokerage in another EU Member State or intend to operate as wholesalers or brokers in the Republic of Croatia are obliged to notify the beginning of their operations to the Agency for Medicinal Products and Medical Devices (HALMED).

The application should be accompanied by:

  1. Completed application form Record of natural and legal persons with the seat outside of the Republic of Croatia operating as wholesalers or brokers in the Republic of Croatia (.doc, .pdf) containing the information necessary for notification to HALMED about the beginning of the wholesale or brokerage operations in the Republic of Croatia according to provisions laid down in the Ordinance on good distribution practice, granting wholesale licenses for medicines, granting brokerage licenses and granting good distribution practice certificates (Official Gazette, No. 83/13),
  2. Copy of the current wholesale or brokerage license,
  3. Phone number of the contact person available 24 h and responsible for recall and interruption of placing products on the market.

Applicants are entered by HALMED in the records within 90 days from the arrival of the complete application and are given attestations on notification under Art 115, 121 and 212 of the Medicinal Products Act (Official Gazette, No. 76/13).

The List of Records of issued attestations is accessible here and is regularly updated.