News and Educations

The European Medicines Agency has recommended a suspension of marketing authorisations for medicinal products Tredaptive, Pelzont and Trevaclyn (nicotinic acid/laropiprant)

23.01.2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a suspension of marketing authorisations for medicinal products Tredaptive, Pelzont and Trevaclyn from the EU countries. The CHMP has concluded that the benefits of the aforementioned medicinal products no longer outweigh the risks of their use. The CHMP opinion will be forwarded to the European Commission for adoption of legally binding decisions. The medicinal products Tredaptive, Pelzont and Trevaclyn have never been placed on the Croatian market.

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The Ministry of Health has published the Medicines Act Proposal

23.01.2013

The Agency for Medicinal Products and Medical Devices (HALMED) informs that the Ministry of Health of the Republic of Croatia has published on its web pages the Medicines Act Proposal with the final Act Proposal. Comments, suggestions and opinions with regard to this Medicines Act Proposal with the final Act Proposal may be forwarded by 1st February 2013 to the Ministry of Health.
The Medicines Act Proposal and further information is available on the web pages of the Ministry of Health under the link Legislation/Act Proposals, or under the link in the continuation of this information.

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Batch release after the accession of the Republic of Croatia to the EU

18.01.2013

Taking into account the soon accession of the Republic of Croatia to the European Union, HALMED would like to inform marketing authorisation holders about the Article 51 of the Directive 2001/83/EC, which Croatia has to transpose in its national legislation, that from 1 July 2013 every batch of a medicinal product authorised in Croatia will have to be released by the qualified person for batch release (QP) in the EU/EEA.
The aforementioned means that a medicinal product manufactured in a third country (out of EU/EEA territory) will be the subject of re-testing after importing into the EU/EEA territory, except in the case where a Mutual Recognition Agreement (MRA) or other adequate arrangements apply encompassing the Good Manufacturing Practice for the imported product. If such an agreement is in effect, the quality control (testing) in the country of origin may be accepted.
It is worth to mention that a Mutual Recognition Agreement includes only the quality control (testing) of a medicinal product batch, whereas the batch release must be completed in the EU/EEA for every batch authorised in Croatia.
Detailed information on the batch release after the accession of the Republic of Croatia to the EU will be available in the section Croatian accession to the EU/Batch release after Croatia’s accession to the EU, or in the continuation of this information.

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Dear Health Care Professional Letter about the risk of fatal air or gas embolism due to inappropriate use of the spray applicator attached to a pressure regulator during administration of the sprayable fibrin sealant Tisseel Lyo

15.01.2013

The company Agmar d.o.o., the marketing authorisation holder for the medicinal product Tisseel Lyo has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals informing them about the risk of fatal air or gas embolism due to inappropriate use (exceeded recommended pressure, inadequate distance from the tissue surface) of the spray applicator attached to a pressure regulator during administration of the sprayable fibrin sealant Tisseel Lyo.
You may view the Dear Health Care Professional Letter in the continuation of this information.

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Dear Health Care Professional letter about the new contraindication of the medicinal product Pradaxa (dabigatran etexilate) in patients with a prosthetic heart valve that need anticoagulant treatment

09.01.2013

The company Boehringer Ingelheim Zagreb d.o.o., the marketing authorisation holder for the medicinal product Pradaxa, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care providers notifying them about the new contraindication in patients with a prosthetic heart valve that need anticoagulant treatment. The contraindication is introduced due to an increased risk of thromboembolia and bleeding as compared to warfarin.
You may view the text of the letter in the continuation of this information.

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Information about the recall of one batch of the medicinal product Parfalgan 10 mg/ml solution for infusion

09.01.2013

The company PharmaSwiss d.o.o., the marketing authorisation holder for the medicinal product Perfalgan 10 mg/ml solution for infusion, is recalling, upon HALMED’s request, the batch 2A74306, of the medicinal product Perfalgan 10 mg/ml, solution for infusion. The decision has been taken following a quality defect report due to a change in the colour of the solution for infusion.
The marketing authorisation holder has informed all their wholesalers and hospital pharmacies about the recall.

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A new sub-section launch within the section Documentation upgrading: Instructions for marketing authorisation holders for implementing the Braille script on the packaging of medicinal products

04.01.2013

The Agency for Medicinal Products and Medical Devices has launched on its webpages a new sub-section within the section Documentation upgrading, entitled Instructions for marketing authorisation holders for implementation of the Braille script on the product packaging.

Instructions for readability testing of the package leaflet will be published in this section of HALMED’s webpages in due time.

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Information to holders of the medical device registration about the changes related to Croatia’s accession to the EU

03.01.2013

The Agency for Medicinal Products and Medical Devices (HALMED) informs all the holders of the medical device registration, that from 1 June 2013, HALMED will cease to accept applications for registration of medical device manufacturers from legal entities in the Republic of Croatia who represent manufacturers with headquarters in the EU or EEA, as well as manufacturers with headquarters outside the EU or EEA territory, that already have an authorised representative in the EU/EEA. More so, HALMED will cease to accept applications for notification of the risk class I of medical devices into the registry.

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