Distribution, Manufacturing and Inspection

Approval for Entry/Import of Medicinal Products

Only medicinal products authorised by the Agency for Medicinal Products and Medical Devices (HALMED) or European Commission and medicinal products authorised for parallel import or parallel distribution may be distributed in the Republic of Croatia.

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 on their own responsibility
  • if there is a medically justified need, in order 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 (Official Gazette, No. 76/13 and 90/14).

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).

The following conditions must be fulfilled for the granting of approval for entry or importation of medicinal products:

  1. that a medicinal product has a marketing authorisation in one of the member states of the European Union (EU) or in the third country, if that medicinal product is not available on the EU market
  2. that the medicinal product is labelled and accompanied by a package leaflet on one of the languages of member states of the European Union, in Latin script
  3. that the patient cannot be treated with a medicinal product authorised in the Republic of Croatia
  4. that there is an urgent, medically justified need
  5. in case of entry of a medicinal product, that the marketing authorisation for that medicinal product in the Republic of Croatia has not been revoked or rejected due to reasons related to quality, safety of use or efficacy of the medicinal product, or that the medicinal product has not been withdrawn from the market in the Republic of Croatia pursuant to the Article 62 of the Medicinal Products Act, or in case of importation of such a medicinal product that its marketing authorisation has not been revoked or rejected due to reasons related to quality, safety of use and efficacy of the medicinal product or that it has not been withdrawn from the market in member states of the European Union pursuant to the Article 62 of the Medicinal Products Act.

Submission of applications for the granting of approval for entry or importation of medicinal products

In addition to the written application for the granting of approval the applicant also submits to HALMED:

  1. a clarified statement by a health institution,aside from pharmacy institutions, on the requirement for a medicinal product which has not been authorised in the Republic of Croatia and which will be used to treat patients in that institution, also specifying the required amount of the medicinal product. The statement is signed by the head of the health institution and the president of the Committee for Medicinal Products, if that health institution has a Committee for Medicinal Products,

or

  1. a prescription, pursuant to provisions of the Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products (Official Gazette, No. 86/13, 90/13, 102/14, 107/15 and 72/16), prescribed by a medical doctor or doctor of dental medicine in charge of treatment, in original and copy. The amount of a medicinal product for which approval for entry or importation into the Republic of Croatia based on a prescription is sought should comply with conditions prescribed by a specific regulation on benchmarks for the classification of medicinal products and the prescription and dispensing of prescription medicinal products.

The applicant submits all data required for the granting of an approval via the program Medicinal Products, in accordance with instructions available here, along with a written application on a CD or DVD. The maximum number of 150 individual prescriptions can be entered into the program Medicinal Products.

Approvals for entry or importation of medicinal products are granted for each supplier individually. The proforma invoice enclosed to the application should entirely reflect the route of entry or importation of a medicinal product, and for each medicinal product the information on the manufacturer qualified for batch release in the country in which the medicinal product is authorised and from which entry or importation into the Republic of Croatia is realized should be included.

In addition to the application, applicants also submit:

  • a proof of paid expenses of the procedure of approval, as well as
  • a proof of paid administrative fee.

In the cases of submission of applications for the granting of approval for entry or importation of batches of immunological medicinal products or medicinal products from human blood or plasma the applicant also submits to HALMED the information on the batch as well as the Official Control Authority Batch Release (OCABR) Certificate, or a corresponding certificate on the conducted quality control of the batch of immunological medicinal product, confirming that the manufacturing and medicinal product quality control have been performed in line with the requirements of good manufacturing practice. If the applicant, at the moment of submission of application, does not dispose of the information on the medicinal product batch to be delivered, the application should be accompanied by the specified certificates for the medicinal product batch distributed in the exporting country, whereas the information on the medicinal product batch acquired through entry or importation as well as corresponding certificates are delivered to HALMED subsequently.

The information on the batches of immunological medicinal products or medicinal products from human blood or plasma acquired through entry or importation is published here.

In the case of importation of medicinal products from third countries, applicants should accompany the application for the granting of approval, submitted to HALMED, with a certificate confirming that the manufacturing and quality control of the imported medicinal product batch have been performed in line with the requirements of good manufacturing practice.

In exceptional cases, as a measure of the protection of public health, HALMED considers applications for the granting of approval for importation of medicinal products which have marketing authorisations in third countries, or exceptionally for entry or importation of medicinal products which do not have marketing authorisations, provided that they are manufactured by holders of manufacturing authorisations that manufacture medicinal products in line with requirements of good manufacturing practice, about which the applicant is able to submit a proof.

The approval for entry or importation of a medicinal product is valid until the moment when the entire approved quantity of the medicinal product is acquired for the user through entry or importation, or by the date until which the approval is granted (with the maximum duration of a year from the day of the granting of approval).

In the case of a shortage of a medicinal product authorised in the Republic of Croatia, as a measurement of ensuring an adequate and timely supply of the Croatian market with medicinal products, the marketing authorisation holder can propose to HALMED a plan of supply of the market with the medicinal product, which includes the approval of HALMED for the submission of application for the granting of approval for the placing on the market of medicinal products pursuant to the Article 129 of the Medicinal Products Act, in order to maintain the supply of the market. HALMED will consider such an application and, in the case of endangerment of public health, will grant an approval for entry or imporation of the medicinal product which is not authorised in the Republic of Croatia, in order to ensure the supply of the market, or the supply of patients with the medicinal product in question, until the shortage of the authorised medicinal product is resolved.

Applicants can submit all the questions related to the submission of applications pursuant to the Article 129 of the Medicinal Products Act to HALMED via e-mail at the address interventniuvoz@halmed.hr.

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