• Home
  • Legal Notices and Terms of Use
  • Sitemap
  • Contacts
  • Hrvatski
 
Search
Newsletter
Enquiries
Rapid Alert System
Generic Medicinal Products and Interchangeability
Application Web ponude
bullet News
bullet About Us
bullet Fees
bullet Public Procurement
bullet Central Ethics Committee
bullet International Cooperation
bullet Seminars and Workshops
bullet Useful Links
bullet Legislation
bullet Publications and Reports
bullet Forms
bullet Approval for the Import
bullet Job and Career
bullet MRP and DCP procedures
bullet Contacts
SPC and PIL
Latest Information
Quality Policy
Code of Conduct
Freedom of Information
User Satisfaction
Complaints Procedure
RSS - Really Simple Syndication
Informacije o lijekovima
On-line prijava nuspojava
Čitajte uputu o lijeku Prijavite nuspojave na lijekove
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]

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]

Dear Healthcare Professional Letter on the potential risk for patients and healthcare personnel when handling broken/cracked Velcade vials
31.07.2014.

Johnson&Johnson S.E. d.o.o. has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the potential risk for patientrs and healthcare personnel on the potential risk for patients and healthcare personnel handling with broken/cracked Velcade 1 mg and 3,5 mg vials during use of the product.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

[more]

Recall of certain batches of Norcuron 10 mg powder for solution for injection or infusion (vecuronium bromide)
30.07.2014.

Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Norcuron 10 mg powder for solution for injection or infusion, has informed the Agency for Medicinal Products and Medicla Devices (HALMED) on the recall of the batches 665196 and 668521 of this medicine from wholesalers.
The recall is due to an error discovered in the Package leaflet.
Detailed information is accessible under the link below.

[more]

New Amendment to the Medicinal Products Act
30.07.2014.

The Amendment to the Medicinal Products At was published on 25 July 2014 in the Official Gazette.
This Amendment is accessible on the HALMED’s webpages in the Legislation Part and under the link below.

[more]

Notice on suspected counterfeited medicines
29.07.2014.

The Agency for Medicinal Products and Medical Devices (HALMED)has received via rapid alert system from the German competent authorities a notice about a number of suspected counterfeited products.
Neither of these suspected batches have been on the Croatian market.
Detailed information is accessible under the link below.

[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]