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News

European Medicines Agency released recommendations on the classification status of ellaOne
21.11.2014.

The European Medicines Agency (EMA) on its webpages has published a press release on the recommendations that will be forwarded to the European Commission for final Decision concerning the classification status of ellaOne. The entire press release is accessible below.

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Dear Healthcare Professional Letter on exfoliative dermatitisan and skin exfoliation in patients treated with ustekinumab (Stelara)
21.11.2014.

Janssen in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) has sent a letter to healthcare professionals on the risk from exfoliative dermatitis in patients treated with uskelimumab (Stelara).

More information and the Dear Healthcare Professional Letter are accessible under the link below.

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Expert Workshop “OTC Medicines: the Role of Good Classification Practices in Promoting Medication Safety and Accessibility of in Europe” held in Zagreb
21.11.2014.

The Expert Workshop "OTC Medicines: the Role of Good Classification Practices in Promoting Medication Safety and Accessibility of in Europe” was organised by the European Directorate for the Quality of Medicines and Health Care (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) from 20 to 21st November 2014 in Zagreb. Almost hundred participants from national and European competent authorities for medicines, healthcare professionals, patient organisations and pharmaceutical industry from even 19 countries involved in classification of medicines as regard their supply took part in the workshop.

Details are accessibe under the link below.

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Instructions for application of variations resulting from the referral procedurefor bromocriptine containing medicines
18.11.2014.

The European Commission endorsed on 30 October 2014 Decision on marketing authorisations for bromocriptine-containing medicines, under Article 31 of Directive 2001/83/EC of the European Parliament and Council (procedure number EMEA/H/A-31/1379). Details are available on the European Commission’s webpages, or here.

More information is accessible under the link below.

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Notice on cases of illegal distribution of medicinal products in the EU
18.11.2014.

The Agency for Medicinal Products and Medical devices (HALMED) has received a notice from Spanish competent authorities concerning discovered illegal medicines distribution in Spain that may affect also other EU Member States and third countries. For illegally distributed medicinal products quality, safety and efficacy cannot be granted and therefore these medicines are considered counterfeits.

More information is accessible under the link below.

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European Antibiotic Awareness Day
17.11.2014.

The European Antibiotic Awareness Day (EAAD) is manifested on 18 November every year. This manifestation is organised by the European Centre for Diesease Control and Prevention (ECDC) aimed at raising awareness on microorganism resistance to antibiotics and importance of their rational use.

HALMED is monitoring from the close the antibiotic use in Croatia and appeals on their rational and correct use. The correct use of antibiotics will preserve their activity, enforce their clinical efficacy and reduce the potential for antibiotic resistance, thus in the end resulting in reuction in morbidity and mortality due to infections caused by resistant bacteria.

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MRP i DCP postupci
Croatian Pharmacopoeia
Scope
Events - HALMED

Šibenik, 11-12 November 2014
International regulatory and pharmacovigilance conference "Croatian Mark in the EU"

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international regulatory and pharmacovigilance conference entitled "Croatian Mark in the EU" which will be held from 11 to 12 November 2013 in Hotel Ivan, Solaris, in Šibenik.

All interested for participation may register via registration form, which is, along with the agenda and detailed information, accessible under the link below.

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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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