News and Educations

Adverse Drug Reactions Report for 2009

30.05.2010

On 31 May 2010, the Agency for Medicinal Products and Medical Devices (HALMED) posted on its website the Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2009. The Report was drafted in accordance with the Medicinal Products Act (Official Gazette Nos. 71/07 and 45/09) and the accompanying Ordinance on Pharmacovigilance (Official Gazette No. 125/09), pursuant to which HALMED monitors adverse drug reactions (ADRs) in the Republic of Croatia that are related to the marketed medicinal products and the medicinal products in clinical trials, which healthcare professionals, marketing authorisation holders and clinical trial authorisation holders have an obligation to report.

As of the second half of 2009, ADR notifications can be sent to the HALMED by patients, too, as set forth in the new Ordinance on Pharmacovigilance (Official Gazette No 125/09).

17th International Workshop on the Screening and Surveillance of Blood Borne Pathogens held in Zagreb, in Hotel The Regent Esplanade, on 26-27 May 2010

26.05.2010

On 26-27 May 2010, 17th International Workshop on the Screening and Surveillance of Blood Borne Pathogens is held in Zagreb, in Hotel The Regent Esplanade. This international event, held annually, is organised by International Plasma Fractionation Association (IPFA) and Paul Ehrlich Institute (PEI), and its purpose is the strengthening of international cooperation and sharing of experience in blood transfusion. It is hosted by the Institute of Immunology, Zagreb.

Notice on submission of applications for approval for the import of medicinal products and/or medical devices

25.05.2010

We would hereby like to notify all applicants for approval for the import of medicinal products and/or medicinal devices that starting with 1 June 2010 all applications have to be submitted on CDs or DVDs only. We will no longer be able to accept applications on floppy discs.

Notice on suspected quality defect of the medicinal product Rispolept Consta 25 mg, 37,5mg and 50 mg extended-release suspension for injection for intramuscular use

24.05.2010

The company Johnson & Johnson S.E. d.o.o., in collaboration with the Croatian Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional letter about the suspected quality defect of the medicinal product Rispolept Consta 25 mg, 37,5mg and 50 mg extended-release suspension for injection for intramuscular use.

Start of the 15th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) of the Council of Europe, Hotel Le Méridien Lav (Podstrana, Split)

19.05.2010

On Tuesday, 18 May 2010, in Hotel Le Méridien Lav (Podstrana, Split), 15th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) of the Council of Europe, hosted by Croatia for the first time, was officially opened. Previously, the annual meetings were hosted by Vienna, Prague, Rome, Limassol (Cyprus) and other cities in the Council of Europe member states.

The Agency taking part in the 38th International Medicine and Technology Fair

13.05.2010

38th International Medicine and Technology Fair was opened at the Zagreb Fair on 13 May 2010 under the auspices of the Ministry of Health and Social Welfare of the Republic of Croatia.

Two points awarded by the Croatian Medical Chamber for an adverse drug reaction notification

12.05.2010

As of 10 March 2010, instead of 0.5 points, the Croatian Medical Chamber has been awarding 2 points for an adverse drug reaction (ADR) notification.

Newly approved medicinal products

10.05.2010

Here you can find a list of newly approved medicinal products between 1st April 2010 and 30th April 2010.

Report of suspected quality defect of the medicinal product Talofen (promazine) 25 mg/ml, Lot No. 9814

07.05.2010

On 7 May 2010, the Agency for Medicinal Products and Medical Devices received a report on suspected quality defect of the medicinal product Talofen (promazine) 25 mg/ml, lot number 9814, manufactured by Pierrel S.p.A., Italy. Talofen is not authorised for marketing in the Republic of Croatia; it is only exceptionally imported for the treatment of patients in health institutions.

A Dear Healthcare Professional letter to physicians on the relationship of hypersensitivity and infusion reactions to the treatment with bevacizumab (Avastin®)

29.04.2010

Roche d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices, on 29 April 2010, sent a Dear Healthcare Professional letter to prescribing physicians on new safety data for AVASTIN 25 mg/ml concentrate for solution for infusion (bevacizumabum).

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