News and Educations

Launch of the Croatian Pharmacopoeia Supplement 3.2.


The Agency for Medicinal Products and Medical Devices (HALMED) has published the second Supplement, labelled 3.2. of the online Croatian Pharmacopoeia Edition 3.0. This supplement is based on the second Supplement of the eighth European Pharmacopoeia Edition published on the 1 January 2014 and coming into effect on the 1 July 2014.

In addition to harmonised texts and appropriate commentaries of Pharmeuropa, this supplement contains the translation of the Resolution CM/ResAP (2011)1 - Quality assurance and safety of pharmaceutical preparations for a specific named patient.

Every Supplement is an integral Croatia Pharmacopoeia Edition containing all news and corrections, or modifications from the corresponding European Pharmacopoeia Supplement in which the Pharmacopoeia may be entirely searched throughout.

We remind that under Article 179, paragraph 3 of the current Medicinal Products Act (Official Gazette, No 76/13) stipulates that "the quality of a medicinal product or raw materials for its manufacture, including raw materials for its immediate packaging, shall comply with the Croatian Pharmacopoeia, while the medicinal product shall be manufactured and subjected to quality control in accordance with procedures and requirements of the valid European Pharmacopoeia. Where a medicinal product is not included in either Croatian Pharmacopoeia or European Pharmacopoeia, its quality shall comply with a pharmacopoeia recognised in the European Union or with other internationally recognised standards”. The medicinal product in this case encompasses officinal and galenic preparations or finished medicinal products containing substances of chemical, human, animal or herbal origin.

According to current Good Pharmacy Rules, the Croatian Pharmacopoeia belongs to the pharmacy’s mandatory scientific literature. Bearing in mind that that the Pharmacopoeia is subject to regular modifications in order to improve the practice, it is an obligation of every pharmacist to use the current Pharmacopoeia edition in his/her work.

The annual license for use of every Croatian Pharmacopoeia edition, as well as supplements that are regularly published, issues the Agency for Medicinal Products and medical Devices (HALMED). The price of one license is 930,00 kn + VAT. Every license may be used on two computers.

The registration may be carried out via this link, by filling out the required information, based on which a license is created. After the payment has been done according to the offer, the client will be provided with the entire Pharmacopoeia edition. A notice on activation of the access will be sent by e-mail alongside with the appropriate password.

After accessing the Croatian Pharmacopoeia, the current edition/supplement will be be automatically opened and all accessible editions/supplements, with the entire Pharmacopoeia, may be searched by clicking on the "Edition” menu in the Pharmacopoeia headline.

In order to provide insight into possibilities offered by the integral Croatian Pharmacopoeia edition, a demo Pharmacopoeia version is available that may be accessed here.