Instructions for the submission of applications for entry or importation of medicinal products published on HALMED's website
18.07.2016
The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) published instructions on its website concerning the submission of applications for the placing on the market of medicinal products pursuant to the Article 129 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14).
According to this article, HALMED may exceptionally allow the entry or importation of medicinal products which are not authorised in the Republic of Croatia, and would be used for treatment of patients, in the following cases:
- for emergency treatments of individual patients with a medicinal product prescribed by a medical doctor or dental medicine doctor in charge of treatment
- if there is a medically justified need to protect human health
- in case of natural disasters or other emergencies.
Applications for the granting of approval for entry of medicinal products from other member states of the European Union or the European Economic Area can be submitted to HALMED by wholesale distributors that perform wholesale distribution of medicinal products pursuant to the Article 115 of the Medicinal Products Act.
Applications for the granting of approval for importation of medicinal products from the third countries can be submitted to HALMED by importers (holders of manufacturing authorisations which include importation of medicinal products from the third countries).
Instructions related to the submission of applications for the granting of approval for entry and importation of medicinal products are available on HALMED's website, in the section Distribution, Manufacturing and Inspection/Distribution/Approvals, or here (in Croatian).
