News and Educations

Information on temporary shortage of the medicinal product Xenical 120 mg hard capsules (orlistat)

20.07.2012

Roche d.o.o., the marketing authorisation holder for Xenical 120 mg hard capsules (orlistat), has informed the Agency for Medicinal Products and Medical Devices on temporary shortage of the aforementioned medicinal product. The shortage is due to the established difficulties in manufacturing and laboratory practice at manufacturing the intermediates and active substances at the Roche's manufacturing site at Roche Carolina Inc., Florence, South Carolina.

There is another product available on the Croatian market with the same active substance from another manufacturer, not affected by the shortage.

New informations on the availability of the medicinal product Xenical, will be promptly made publicly available.

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Under the column Croatian accession to the EU, a new subcolumn has been launched: Documentation upgrading for medicinal products

17.07.2012

Within the column CROATIAN ACCESSION TO THE EU – Instructions for marketing authorisations on the webpages of the Agency for medicinal products and medical devices, a new subcolumn has been launched under the title Documentation upgrading for medicinal products.
The new subcolumn contains useful instructions for marketing authorisation holder with regard to dossier upgrading which means a harmonisation of the documentation for medicinal products with the acquis communautaire for products authorised in Croatia before the accession to the EU.
Within the aforementioned column there were informations posted with regard to medicines authorisation via centralised , mutual recognition, decentralised and national procedure as well as the information to marketing authorisation holders related to application submissions before the accession. The column will be regularly updated with new information.

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Information about the quality control test results on a particular request for the dietary supplement Epimed Gold capsules

13.07.2012

Agency for Medicinal Products and Medical Devices has upon request of the Ministry of Health tested the samples of the dietary supplement Epimen Gold capsules, forwarded to the Agency by the Ministry's Inspectorate Direction.

The testing of the dietary supplement Epimed Gold capsules has been prformed by the HPLC method selective for sildenafil, vardenafil and tadalafil. The aforementioned compounds are active substances contained in medicinal products intented to treat erectile disfunction and are not allowed to be contained in dietary supplements. The analysis was performed within the legal framework of 30 days and the Ministry was promptly informed about the test results.

The Agency warns about the danger of using Epimed Gold capsules, in which the substance that
may cause heavy cardiovascular adverse reactions in consumers with risk factors, has been found. Therefore, the aforementioned substance may not be found in food supplements, that are free for sale on the market, but may be contained only in approved medicinal products as a prescription only medicine. This ensures that a cardiovasular risk of a single patient be estimated, the posology determined and the patient's condition monitored by a doctor, prior to issuing a prescription.

Next you wil find a question and answer session on the test results of the performed laboratory testing of those food supplements in which sildenafil was found.

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Information about the shortage of the medicinal product Lamisil dermGel 1% gel (terbinafin)

11.07.2012

Clinres Farmacija d.o.o., the marketing authorisation holder for the medicinal product Lamisil DermGel 1% gel (terbinafin) has informed the Agency for Medicinal products and Medical Devices (HALMED) about the shortage of the aforementioned medicine. The shortage of the medicine stocks is due to an increase in consumtion. The normalisation of the market supply with the medicinsl product Lamisil DermGel 1% gel is expected in the beginning of September 2012. There is a medicinal product Lamisil 1% cream of the same manufacturer available on the Croatian market, not affected by that shortage.

The public will be proptly informed about the new information about the availability of the medicinal product Lamisil DermGel 1% gel.

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4th Public Educational Campaign on Promotion of Rational Use of Antimicrobial Medicines - JEKA

10.07.2012

The Agency for Medicinal Products and Medical Devices (HALMED) participated as a sponsor and participant of the 4th Public Educational Campaign on Promotion of Rational Use of Antimicrobial Medicines – JEKA. The main goal of this campaign executed for the fourth year continuation is to reduce the unnecessary use of antibiotics.

HALMED carefully monitors the use of antibiotics in Croatia, calls upon a rational and appropriate use and promotes the raise of public awareness on resistance, hence an incorrect and excessive prescription of antibiotics as well as their inappropriate use increase the antimicrobial resistance to antibiotics and increase the risk for development of other diseases.

HALMED calls upon all the doctors and patients to prescribe and use antibiotica responsibly and consciously, bearing in mind the following: antibiotics are intended to treat bacterial infections, but not the viral ones; antibiotics are not used to treat a flu and cold or every single throat ache; antibiotics are not used to reduce a fever; antibiotics should be taken only upon's doctors prescription and the dose administered entirely in equal time intervals.

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Information to marketing authorisation holders on the application submission before the accession to the EU

09.07.2012

Agency for Medicinal Products and Medical Devices informs herewith marketing authorisation holders that the submission of new applications for granting marketing authorisations will be temporarily suspended from 1 December 2012 to 1 July 2013, which means by the access of Croatia to the EU.

The suspension of new application submissions is necessary in order to ensure the Agency's prompt conclusion of the status of procedures of applications submitted according to the current legislation and to facilitate the beginning of implementation of new procedures when Croatia becomes member of the EU.

The period of temporary suspension of application submissions approximately equals to the legal deadline of 210 days, in which, according to the current Act on Medicinal Products, HALMED is required to either grant or reject the marketing authorisation for a medicinal product upon receipt of a valid application. Given that the Croatia's accession to the EU will bring certain changes in the procedures for granting the marketing authorisation, for all the applications that would not be completed prior the accession, it would be necessary to repeat the validation, regardless of the phase of the procedure they are in, in that moment .

In the aforementioned temporary period of submission suspension of applications from 1 December 2012 to 1 July 2013, the submission of applications for renewals and variations will not be suspended.

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New section launch: HOMEOPATHIC PRODUCTS

06.06.2012

Agency for Medicinal Products and Medical Devices (HALMED) has launched on its webpage a new section called „HOMEOPATHIC PRODUCTS“ with information about homeopathic products and procedures for placing them on the market: the enrollment in the registry and the marketing authorisation procedure, respectively. Also, the section contains the Application form for the registry enrollment or granting marketing authorisation for a homeopathic product in the Republic of Croatia (in Croatian), as well as useful guidelines providing links to more information.

The section will be regularly updated and supplemented with new findings.

In the following text you can find more information.

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10th Conference of Croatian Pharmacists is taking place in Šibenik

24.05.2012

The 10th Conference of Croatian Pharmacists jointly organised by the Association of Pharmacists of the Zagreb region and the Croatian Pharmaceutical Society, under the auspices of the Ministry of Health started on Thursday, May 24, 2012 in the hotel resort Solaris in Šibenik. This year's topic of the Conference „Croatian pharmacy before the EU accession“ will be held untill May 26, 2012. A satelite symposium on drug interactions co-organised by HALMED is also taking place during the Conference.

During the opening of the Conference, a welcome speech will be held by the head of the Agency for Medicinal Products and Medical Devices (HALMED), Viola Macolić Šarinić, MD, MSc, specialist in clinical pharmacology and toxicology, who will present within the Forum on OTC and self-medication products, the HALMED's strategy for developing the OTC legislation.

The Conference is also attended by other HALMED experts who will during the Symposium give lectures on drug interactions and adverse reactions caused by drug interactions with examples from practice and will also within other sessions of the Conference talk about the import of medicinal products under the legal exemption scheme, counterfeit medicines and medical devices.

Next you will find the programme of the 10th Conference of Croatian Pharmacists.

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