Medicinal Products

Croatian Pharmacopoeia

Having signed the Convention on the elaboration of the European Pharmacopoeia, adopted on 22 July 1964 in Strasbourg, the Republic of Croatia made a commitment on the 14 September 1994 to accept and implement all standards for medicinal products that are published in the European Pharmacopoeia (Ph. Eur.). With the edition of the Croatian Pharmacopoeia (HRF) the overtaken commitment from the Convention on the elaboration of the European Pharmacopoeia is being fulfilled and the European Pharmacopoeia is being implemented in the republic of Croatia. This obligation of the Republic of Croatia was regulated first by the Medicinal Products and Medical Devices Act (Official Gazette, No. 124/97, 53/01, 121/03, 177/04), and afterwards by the Medicinal Products Act (Official gazette, No. 71/07, 45/09, 124/11, 76/13, 90/14).

Every new edition of the Croatian Pharmacopoeia implements requirements from a particular edition of the European Pharmacopoeia. In line with that, the Croatian Pharmacopoeia Edition 6.0 implements requirements from the Eleventh European Pharmacopoeia Edition, or standards published in the general volume of the Eleventh European Pharmacopoeia Edition, and will be receiving corresponding supplements (6.1 - 6.8).

Under the Medicinal Products Act (Official Gazette, No. 76/13, 90/14; Art. 212, Paragraphs 9 and 10) the Croatian Pharmacopoeia is prepared and published by the Agency for Medicinal Products and Medical Devices (HALMED). In order to ensure a high quality of cooperation with Pharmacopoeia users, HALMED founded the Croatian Pharmacopoeia Commission.

In order to facilitate ever wider access to the Pharmacopoeia and simplify its use as well as ensure a regular updating, the new edition of the national Pharmacopoeia is prepared in an online form. In order to help the search certain texts, the new edition is edited in the European Pharmacopoeia manner.

In order to familiarise with the presentation and search manner of the Croatian Pharmacopoeia, a demo version of one of monographs from the Pharmacopoeia with links to corresponding texts can be accessed. The demo version is available here.

After accessing the Croatian pharmacopoeia, a current edition of the pharmacopoeia is opened. Archived and invalid editions, as well as announced editions, can be accessed by clicking on the menu in the header.

On the left side of the screen there is a list of the translated texts from the European Pharmacopoeia (bolded titles are translated completely and others partially). The titles of all texts and monographs included in the current edition of the European Pharmacopoeia are included in special bilingual or trilingual tables with links to translated texts.

By selecting the title on the left side of the screen, the chosen text is opened on the right side. By clicking on the labelled link in the text, the corresponding reagent, method or other linked text are opened. The search is also possible by searching for words (CTRL + F). In the demo version on the left side of the screen for search, only titles that are directly linked to a given monograph are activated.

The list (in Croatian) of texts from the European Pharmacopoeia translated so far and published in the Croatian Pharmacopoeia is available here.

The annual license for using the complete edition of the Croatian Pharmacopoeia, as well as later supplements that will be published by trimester is issued by HALMED. The registration is possible by using this link, with completion of requested information, based on which the license offer is being created. After payment has been made according to the offer, the user will be able to access the entire Pharmacopoeia edition. The message about the activation of access will be sent to the user via e-mail with the corresponding password for access to the Pharmacopoeia.

After accessing the Croatian Pharmacopoeia, the available versions can be searched by clicking on the menu in the header. The opening is set to access the current edition of the Pharmacopoeia.

In case of technical problems you may contact the following address: podrska@halmed.hr, and for all other scientific questions we kindly ask you to contact the address UredZaFarmakopeju@halmed.hr.

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