• 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
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]

Notice about returning of the batch 557867 of Esmeron 10 mg/ml solution for injection to the market
23.07.2014.

Following to the Information on temporary interruption in distribution and use of the batch 557867 of Esmeron 10 mg/ml solution for injection, published on 9 May 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is hereby informing about the returning of this batch to the market.
Detailed information is accessible under the link below.

[more]

Recall of the one batch of Neurobion 100 mg + 100 mg + 1 mg solution for injection
22.07.2014.

Merck d.o.o., the marketing authorisation holder for Neurobion 100 mg + 100 mg + 1 mg solution for injection has in collaboration with the Agency for Medicinal Products and Medical Devices initiated a recall of the batch 180707 of this medicine.
The recall is due to an error on the inner and outer labelling of the medicine, where there is "subcutaneous use” instead of "intramuscular use”. The package leaflet is correctly labelled with "intramuscular use”.

[more]

Notice about temporary interruption of distribution and use of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)
18.07.2014.

Pfizer Croatia d.o.o., the marketing authorisation holder for Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan) has upon Agency’s request initiated a temporary procedure of interruption and use of the batch HC 68E of this medicine. The procedure is due to a suspected quality defect report on the discovered turbid solution that HALMED received on 16 July 2014 by a healthcare professional.The interruption of use of this medicine will be in effect until the results of the extraordinary quality control have been achieved and conclusions on the discovered quality defect made, which will be promptly made publicly available.
The temporary interruption of dispensation and use relates only to the batch HC 68 of this medicine, whereas other available batches may be further dispensed and used.
Detailed information is available under the link below.

[more]

Newly approved medicinal products
16.07.2014.

The list of newly approved medicinal products for the period between 1st June 2014 and 30th June 2014 is available in the continuation of this notice.

[more]

News from the PRAC - July 2014
14.07.2014.

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of a medicine at its July meeting.

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]