News and Educations

Supplement 3.3 of Croatian Pharmacopoeia now available

05.11.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has published a third Supplement to the on-line edition of Croatian Pharmacopoeia labelled 3.3. This Supplement is based on the third Supplement of the eighth edition of European Pharmacopoeia published on 1st July 2014 coming into effect on 1st January 2015 and valid until 31st March 2015.

Every supplement is a complete edition of Croatian Pharmacopoeia with all news and corrections/modifications in the corresponding supplement of European Pharmacopoeia where pharmacopoeia may be entirely searched.

We remind all our colleagues that under Art 179 paragraph (3) of the current Medicinal Products Act (OG 76/13 and 90/14) stipulates the following: "The quality of the medicinal product and starting material for its manufacturing, including the material for the inner packaging must comply with Croatian Pharmacopoeia, or the medicinal product must be manufactured and controlled in compliance with procedures and requirements of the current European pharmacopoeia edition. If the medicinal product is not included neither in Croatian nor in European pharmacopoeia, its quality must comply with the pharmacopoeia recognised in the European Union or other international standards.” The medicinal product in this case refers to: magistral preparation, galenic preparation or finished medicinal product containing substances of chemical, human, animal or herbal origin.

Under current Good Pharmacy Practice, Croatian Pharmacopoeia belongs to the mandatory scientific literature in pharmacies. Taking account that due to practice improvement, pharmacopoeia is subject to regular changes, the task of every pharmacist is to use the current pharmacopoeia edition in his/her practice.

The Agency for Medicinal Products and Medical Devices offers licenses for use of all pharmacopoeia editions including supplement during one year period. The price per license is 930,00 kn + VAT. Every license may be used on two computers.

You may register via this link, by completing the requested information that serve to create an offer for license. After the payment has been done, the user will have access to the entire pharmacopoeia edition. The notice on the activation of access will be sent to the user by e-mail, alongside the corresponding password .

After acceding to Croatian Pharmacopoeia, the current edition/supplement is opened automatically and all available editions/supplement with entire pharmacopoeia may be searched by clicking on the browser Edition in the memorandum of pharmacopoeia.

In order to provide insight in possibilities of the entire Croatian Pharmacopoeia edition, a demo pharmacopoeia version is accessible here.

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