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News

Information on production material imported from the Republic of Korea in 2013
08.09.2014.

Based on the newly received information, upon the Customs Office reported about infliximab, imported from the Republic of Korea, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to provide information related to the production material from the Republic of Korea in 2013, that attracts great interest from the Croatian public and media and is being incorrectly associated to the revocation of the Zagreb Institute of Immunology’s manufacturing license.
There were no finished medicinal products or human vaccines to be used in Croatian patients, or any other alternative to products of the Zagreb Institute of Immunology, but an intermediate product for manufacturing , was imported, more precisely the active substance infliximab that has never been manufactured by the Zagreb Institute of Immunology. The biological substance infliximab is a monoclonal antibody used in manufacturing of a new generation so called "clever” biological medicines and cannot be in neither way associated with the products by the Zagreb Institute of Immunology, hence this manufacturer has never been producing neither this substance nor medicinal products or any other medicinal product intended to treat patients with the same indication as infliximab. Therefore, we are highlighting once again that the import of blood products from the Republic of Korea in 2013, that attracted great interest from the public, has not been associated with the revocation of the Zagreb Institute of Immunology’s manufacturing license.
The large amount of the active substance was not imported from the Republic of Korea to the Republic of Croatia for the Croatian healthcare system, but for the needs of the entire EU and it was imported in Croatia, because a part of the manufacturing process of this medicine for the whole EU takes place in Croatia.

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Newly approved medicinal products
22.09.2014.

The list of newly approved medicinal products for the period between 1st August 2014 and 31st August 2014 is available in the continuation of this notice.

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Dear Healthcare Professional Letter on the new/modified storage conditions of Octanate 1000 IU powder and solvent for solution for injection and Octanate 500 IU powder and solvent for solution for injection
16.09.2014.

Jana Pharm d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new/modified storage conditions for Octanate.
Taking account that the new package leaflet indicating the new storage conditions at 2 to 9°C cannot be provided, in order to ensure a continuous supply chain, HALMED has exceptionally and temporarily allowed the placing of the product on the market containing the previous package leaflet with previously authorised storage conditions at 25°C that are not valid any more.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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PRAC News – September 2014
15.09.2014.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) completed on its meeting held in September , the safety review of Valdoxan and Thymanax (agomelatine).
Detailed information is accessible under the link below.

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Dear Healthcare Professional Letter on new risk minimisation measures for osteonecrosis of the jaw and hypocalcaemia in patients treated with denosumab 60 mg (Prolia)
11.09.2014.

Amgen Europe B.V. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals on the new risk minimisation measures for osteonecrosis of the jaw (ONJ) and hypocalcaemia in patients treated with Prolia.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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Notice on cessation of production of Vagifem 25 microgram vaginal tablets (estradiol) and kliogest 2 mg/1 mg film-coated tablets (estradiol, norethisterone) for the Croatian market.
11.09.2014.

Novo Nordisk Croatia d.o.o., the marketing authorisation holder for Vagifem 25 microgram vaginal tablets and Kliogest 2 mg/1 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to cease permanently the production of these medicines for the Croatian market. This decision has been taken due to commercial reasons and it is not associated with quality, efficacy or safe use of these medicines.

The batches of these medicines currently on the Croatian market, remain in the supply chain until they have been out of stock or they shelf live has expired.

There are other medicinal products containing the same active substances on the Croatian market, intended for hormone replacement therapy, with different strengths, though. Therefore, all patients using these medicines should consult their doctor about a change of medication.

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MRP i DCP postupci
Croatian Pharmacopoeia
Scope
Events - HALMED

Šibenik, 11-12 November, 2014
Regulatory and pharmacovigilance conference

The Agency for Medicinal Products and Medical Devices (HALMED) is orginising a regulatory and pharmacovigilance conference to be held from 11 to 12 November 2014 in Šibenik. The conference is intended for marketing authorisation holders in the Republic of Croatia (especially to those employed in regulatory affairs and pharmacovigilance), pharmacists, clinical pharmacologists, competent authorities for medicines and qualified persons for pharmacovigilance. The languages of the conference are Croatian and English.
The organiser will apply at the Croatian Medal Chamber and The Croatian Chamber of Pharmacy to obtain permanent education credits for attending the conference.
The conference programme and information related to registration for the conference will soon be available at the HALMED webpages.

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Educational course “Distribution of medical devices”

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.

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Educational course “Introduction to medical devices vigilance”

The educational course “Introduction to medical devices vigilance”, organised by the Agency for Medicinal Products and Medical Devices (HALMED), will take place at the HALMED’s premises at Ksaverska cesta 4. The exact date will be announced when enough interested participants have been gathered (the approximate duration is 6 school hrs).
More information is available in the continuation of this information.

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Other Events

17-19 September 2014
EudraVigilance Workshop – Electronic reporting of Individual Case Safety Reports (ICSRs) in the European Economic Area (EEA)

An Eudravigilance workshop on the electronic reporting of Individual Case Safety Reports (ICSRs) in the European Economic Area (EEA), organised by Drug Information Association (DIA) and the European Medicines Agency (EMA) will be organised from 14-19 September 2014 in Zagreb. The workshop will be held at HALMED’s premises in the Robert Frangeš Mihanović Street 9 (Sky Office Busines Building).
Detailed information, program and registration form are accessible under the link below.

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