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News

HALMED is organising a regulatory and pharmacovigilance conference
17.06.2014.

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.

[more]

European Commission published a booklet on biosimilar medicines
28.08.2014.

The European Commission has made publically available a booklet untitled What you need to know about biosimilar medicinal products. The publication provides information on biosimilar medicinal products and regulation of biosimilar medicinal products in Europe and contains questions and answers intended for patients and healthcare professionals.

The publication is accessible under the link below.

[more]

European Medicines Agency published an informative booklet on the European regulatory system for medicines
27.08.2014.

The European Medicines Agency (EMA) published today an informative booklet representing the functioning of the European regulatory system for medicines. The booklet provides information on authorisation procedures and monitoring of medicines in the European union, as well as the functioning of the European regulatory network for medicines thus ensuring safe and efficient medicines for patients in the European Union.
The booklet is accessible on the EMA’s webpages, or under the link below.

[more]

Newly approved medicinal products
27.08.2014.

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

[more]

EudraVigilance Workshop – Electronic Individual Case Safety Reporting (ICSR) in the EEA
26.08.2014.

From 17 to 19 September 2014 an EudraVigilance Workshop will be held in Zagreb on electronic Individual Case Safety Reporting (ICSR) in the EU entitled "Electronic Reporting of ICSRs in the EEA”, organised by Drug Information Association (DIA) and the European Medicines Agency (EMA). The workshop will be held at the HALMED’s premises, at the address: Robert Frangeš Mihanović Street 9 (Sky Office Business Building).
Detailed information is accessible under the link below.

[more]

Supply of the Croatian market with antitoxin for counteracting the effects of the black widow spider venom
11.08.2014.

In the Republic of Croatia there are no medicinal products containing immunoglobulin-antitoxin for counteracting the effects of black widow spider venom which have been granted a marketing authorisation. For emergency treatments of patients in the Republic of Croatia, the Agency for Medicinal Products and Medical Devices (HALMED) grants approval for entry/import of medicinal product without marketing authorization.

In line with the legal requirements, obliging the wholesalers to ensure a suitable and continuous supply of medicinal products within the limits of their responsibilities, HALMED has received a wholesaler request for the import of the antitoxin for counteracting the effects of the black widow spider venom of the manufacturer Merck Sharp & Dohme Corp., USA. HALMED has promptly granted approval for import, and the delivery is currently in progress.

HALMED will continue to monitor the supply of the Croatian market with antitoxin for counteracting the effects of the black widow spider venom and will promptly inform the public on all new information.

[more]

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.

[more]

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.

[more]

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.

[more]

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.

[more]