News and Educations

Supplement 3.6 of Croatian Pharmacopoeia available now

05.10.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has released the sixth Supplement to the third on-line Edition of Croatian Pharmacopoeia designated 3.6. This Supplement is based on the sixth Supplement of European Pharmacopoeia released on 1st July 2015, coming into effect on 1st January 2016. The corrected texts published in European Pharmacopoeia 8.6 will come into effect at their release.

Based on a co-operation agreement between HALMED and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), signed in February 2015, HALMED has acquired translation and publishing rights of the British Pharmacopoeia texts relating to preparations as unlicensed medicines in Croatian Pharmacopoeia. According to this, in the non-mandatory section of the newest Croatian Pharmacopoeia Supplement (Chapter 15), we publish translations of texts and list of unlicensed preparations, whose monographs and recipes may be found in British Pharmacopoeia. Since the magistral and galenic preparations in Croatia is not stipulated by a special ordinance, these texts should illustrate one of the highest standards for regulating these medicines even though due to a number of differences in the approach, the British solution may not be simply copy-pasted in Croatia.

There is a short review of revised texts published in this edition in the chapter Commentaries of revised texts in the Supplement 8.6 of Croatian Pharmacopoeia.

Every supplement represents the complete Croatian Pharmacopoeia Edition where all novelties and corrections or changes from the corresponding supplement of European Pharmacopoeia Edition are being added and the Pharmacopoeia may be entirely searched within.

The annual license for use of every Croatian Pharmacopoeia Edition, as well as for supplements that are regularly published, are issued by the Agency for Medicinal Products and Medical Devices (HALMED). The price per license is 939.00 kn + VAT. This license may be used on all computers.

The registration is available via this link, by completing the requested details that serve for creation of license offers. After the has been paid according to this offer, the user will have access to the complete Pharmacopoeia Edition. The user will receive an e-mail with a password and a notification on the activation of access.

After accessing Croatian Pharmacopoeia, the current Edition/Supplement is automatically opened and all available Editions/supplements with the entire Pharmacopoeia may be searched by clicking on the Edition menu in the Pharmacopoeia header.

In order to provide an insight in possibilities offered by the complete Croatian Pharmacopoeia edition, users have access to a demo Pharmacopoeia version, which is accessible here.

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