News and Educations

Changes in classification of acetylsalicylic acid-containing medicines with dispensation status without prescription

04.09.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has reviewed the existing classification of acetylsalicylic acid-containing medicines with dispensation status without prescription (ATC code: B01AC06) and adopted conditions for authorisation status “without prescription” for these medicines.
In addition, marketing authorisation holders for acetylsalicylic acid-containing medicinal products (ATC code: B01AC06) with the approved dispensation status “without prescription” are called under Article 50, paragraph 2 of the Act to submit an application for variation to the documentation for medicine to comply with conditions indicated in this notice, within 30 days from the publishing of this notice.
These conditions, detailed instructions for application of variations in the documentation and the key data that should be included in the documentation are accessible on the HALMED webpages in the OTC medicines/conditions for dispensation without prescription section, or 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

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

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

For Patients and Public

For Health Care Professionals

For Industry Representatives