News and Educations

New Supplement 3.1. of the Croatian Pharmacopoeia

21.01.2014

The Agency for Medicinal Products and Medical devices (HALMED) has published the first Supplement of the online Croatian Pharmacopoeia 3.0 edition, labelled 3.1. This Supplement is based on the first Supplement of the eighth European Pharmacopoeia Edition published on 1 October 2013, entering into force on 1 April 2014.

Every Supplement represent the entire Croatian Pharmacopoeia edition updated with news and corrections, or modifications from the corresponding European Pharmacopoeia Supplement and serve to search throughout the Pharmacopoeia.

The Section IV. The content of the first supplement of the eighth edition 8.1 contains all news, corrections, or modifications, whereas a special chapter Pharmeuropa contains commentaries to amendments published in Pharmeuropa.

We remind that "the quality of the medicinal product , as well as starting materials for it production, including containers for primary packaging, must be in compliance with the Croatian Pharmacopoeia, or the medicinal product must be manufactured and its quality controlled according to the European Pharmacopoeia procedures and requirements” as set out under Article 179, paragraph 3 of the Medicinal Products Act (Official Gazette, No 76/13). The medicinal product in this case involves magistral and galenic preparations or finished medicinal products with substances of chemical, human, animal or herbal origin.

According to current Good Pharmacy Practice, the Croatian Pharmacopoeia belongs to the mandatory scientific literature in the pharmacy. Taking account that, in order to advance the practice, the Croatian Pharmacopoeia is subject to change, it is mandatory for every pharmacist to sue the current Pharmacopoeia edition in his/her practice.

The annual license for use of every Pharmacopoeia edition, as well as supplements that are regularly published, are issued by 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 achieved under this link, after completing the relevant form, based on which an offer for license is being created. After the payment has been completed according to the offer, the user will have entire access to the Croatian Pharmacopoeia edition. The information on access activation will be sent to the user by e-mail along with the appropriate password.

After accessing the Croatian Pharmacopoeia, the current edition/supplement opens automatically and all available editions/supplements with the entire Pharmacopoeia, may be searched by clicking on the browser Edition in the Pharmacopoeia headline.

In order to provide insight in possibilities offered by the entire Croatian Pharmacopoeia edition, a demo Pharmacopoeia version is accessible under this link.

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