News and Educations

New Price List of the Agency with effect from 1st January 2013

31.12.2012

The new Price List of the Agency for Medicinal Products and Medical Devices (HALMED) coming into effect from 1st January 2013 has been published on the Agency’s web site.
The Price List will apply to all services that the Agency provides and makes out an invoice after the date of coming into effect of this Price List without having regard to the date of the application submission. The Price List may be found under the link Fees.

Opening hours of the HALMED’s Registry Office on 24 and 31 December 2012

19.12.2012

We inform all customers of the Agency for Medicinal Products and Medical Devices, that the opening hours of the Registry Office on Monday, 24 December and Monday, 31 December will be from 8.00 to 12.00 a.m.

Newly approved medicinal products

30.11.2012

Here you can find a list of newly approved medicinal products between 1st October 2012 and 31st October 2012.

List of medicinal products whose marketing authorisation has been suspended or withdrawn

30.11.2012

Here you can find the list of medicinal products whose marketing authorisation was suspended or withdrawn in the period from October 1 to October 31, 2012.

Dear Healthcare Professional letter about the recall of the batch G0460-3 of the Typhim Vi vaccine

21.11.2012

The company Medoka d.o.o., who is the marketing authorisation holder for the vaccine Typhim Vi solution for injection in a pre-filled syringe, vaccine against typhoid fever, polysaccharide, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED), sent a letter to health care professionals about the recall of the batch G0460-3 based on a reported quality defect.
The text of the Dear Health Care Professional letter, you may view in the continuation of this info.

The recall of three batches of the medicinal product Glibenclamid Genericon 3,5 mg tablets

20.11.2012

Genericon Pharma, d.o.o., the marketing authorisation holder for the medicinal product Glibenclamid Genericon 3,5 mg tablets, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to recall three batches (10A014, 10A16A and 10A16 B) of the medicinal product Glibenclamid Genericon 3,5 mg tablets, blister pack of 120 tablets, from the Croatian market.
The decision about the recall was taken after the analysis discovering a slight increase of the acidic acid content, alkyl esters of fatty acids and olefins. Even though toxic components have not been determined, it was decided to recall all the three batches affected by the aforementioned quality defect. The marketing authorisation holder has informed all Croatian distributers about the recall.

Information about the expected shortage of the medicinal product Tienam powder for solution for infusion (imipinem, cilastatin)

20.11.2012

Merck Sharp & Dohme d.o.o., the marketing authorisation holder for medicinal product Tienam, powder for solution for infusion (imipenem, cilastatin) has informed the Agency for medicinal products and medical devices (HALMED) about the expected shortage of the aforementioned product.
The shortage is due to certain difficulties in the manufacturing process and it is expected to last up to several months. Currently available product batches will be distributed on the Croatian market until they are out of stock.
There are other products from the same chemical-therapeutic subgroup currently available on the Croatian market.

Information to marketing authorisation holders on submission of applications before the accession to the EU

12.11.2012

The Agency for Medicinal Products and Medical Devices is expecting a higher influx of new applications for granting marketing authorisations in the period before 1 December 2012, due to a suspension of reception of new applications until 1 July 2013, which means until the date of Croatia’s accession to the EU. We would therefore kindly ask our applicants to notify in advance and book a slot with the HALMED’s Registry at the Sky Office location at +385 1 4884 163, should they submit more than four applications.
The Agency announced the suspension of reception of new applications for granting marketing authorisations on HALMED’s webpages on 9 July 2012.

The regulatory and pharmacovigilance workshop “With HALMED to keep up with the EU” is now open for registrations

08.11.2012

The Agency for Medicinal Products and Medical Devices (HALMED) organises, in collaboration with the Croatian Pharmaceutical Society (HFD) the regulatory and pharmacovigilance conference entitled “With HALMED to keep up with the EU” that will be held from 6 to 7 December 2012 in the Hotel International in Zagreb.
The conference is as of today, 8 November 2012, open for applications. All those interested to participate may apply by using the registration forms which can be found, along with other information in the Seminars and Workshop/Regulatory and Pharmacovigilance Workshop “With HALMED to keep up with the EU” section of HALMED’s webpages or in the continuation of this info.

The report on medicinal product consumption in the Republic of Croatia in 2011

08.11.2012

HALMED has made publicly available the Report on medicinal product consumption in 2011 in the Republic of Croatia which is posted in the Publications and Reports/Reports-Drug utilisation section of our webpages.

For Patients and Public

For Health Care Professionals

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