News and Educations

Dear Healthcare Professionals Letter about a restriction of use of hydroxyethyl-starch (HES): Tetraspan, Voluven and Volulyte

14.11.2013

B. Braun Adria d.o.o. and Fresenius Kabi d.o.o., the marketing authorisation holders for hydroxyethyl-starch-containing medicinal products (Tetraspan 60 and 100 mg/ml solution for infusion, Voluven 6% solution for infusion, Volulyte 6% solution for infusion) have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about new restrictions of use of hydroxyethyl-starch-containing medicinal products (HES) based on the benefits/risks ratio assessment carried out recently in the EU.
Detailed information and the Dear Healthcare Professional Letter are avaiable under the link below.

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New requirements for marketing authorisation holders related to notification of interruption in medicinal product supply chain

13.11.2013

Since a change into the EU pharmacovigilance legislation came into force on the 28 October 2013 which is implemented into the Croatian legislation under Art. 55 of the Medicinal Products Act (Official Gazette, No 76/13), HALMED is publishing below instructions for notification of an interruption of the supply chain in accordance with recommendations of the European Medicines Agency (EMA).

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Submission of new requests for Croatia to act as a Reference Member State (RMS) in MRP and DCP procedures

04.11.2013

HALMED will receive requests for Croatia to act as a Reference Member State (RMS) in Decentralised (DCP) or Mutual Recognition (MRP) procedures for granting marketing authorization for medicinal products between 4 November and 15 November 2013, exclusively by e-mail.

At present, HALMED receives applications for marketing authorization for generic products.

Detailed information regarding requests for Croatia to act as a Reference Member State (RMS) in MRP and DCP procedures can be found in the continuation of this notice.

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Symposium “Adverse reactions – challenges and solutions”

30.10.2013

The symposium “Adverse reactions – challenges and solutions” will be held on 22 November 2013 in the grand lecture hall of the Public Health Institute “Dr Andrija Štampar” in Zagreb. The symposium is organised by the Croatian Academy for Medical sciences, Public Health Institute “Dr Andrija Štampar” and Agency for Medicinal Products and Medical Devices.
Additional information about the symposium, programme and registration for participation are accessible under the following link.

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Notice related to the information about centrally authorised medicinal products in the HALMED data base

30.10.2013

The Agency for Medicinal Products and Medical Devices (HALMED) hereby informs all its users that the data base on the HALMED web pages, alongside the information about medicinal products authorised by HALMED, from now on contains the information about centrally authorised products, authorised by the European Commission following the scientific evaluation by the European Medicines Agency (EMA).
You may find more information about the search of the medicinal product data base, as well as an overview of available data in the Medicinal Products/Database, or in the Medicinal Products/For Patients/Information about medicines – Database section.

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News from the CHMP and CMDh – October 2013

30.10.2013

The Co-ordination Group for the Mutual Recognition and Decentralised Procedure for Human Medicines (CMDh) has adopted the PRAC recommendations about restrictions of use of hydrxyethyl-starch containing solutions (HES) and restrictions of use of short acting beta agonists in obstetric indications.
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) confirmed its previous recommendations about the restriction of use of dihydroergotoxin and metoclopramide and recommended restriction of use of intravenous forms of nicardipine.
More information is accessible under the following link.

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Presentation of the new edition of the Croatian Pharmacopoeia

29.10.2013

The Agency for Medicinal Products and Medical Devices (HALMED) is organising the presentation of the new edition of the Croatian Pharmacopoeia. The presentation will be held on Monday, 11 November 2013 with the beginning at 9 a.m. at Halmed’s premises, Ulica Roberta Frangeša 9 (Sky Business Office, 1st Floor), Zagreb.
The entrance is free, but the number of participants is limited and a pre-registration is required.
According to the Croatian Chamber of Pharmacists this scientific conference carries 1 credit.
Detailed information and the programme of the conference is accessible here.

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Information about the counterfeited medicine Pegasys 180 microgram solution for injection seized in Germany

29.10.2013

A counterfeited medicine Pegasys 180 microgram solution for injection (peginterferon alpha-2a), originating from parallel import has been discovered in Germany. The counterfeited medicine is labelled as “batch B1299B03 EXP 07 2015”. The batch number indicated on the counterfeited medicine is the same as the batch number on the original medicine of the marketing authorisation holder Roche Registration Limited. Roche’s original batch B1299 has been distributed in several countries of the European Union, Pakistan and Australia. We emphasize that the original batch has not been distributed in Croatia. Also, HALMED has neither received any report to quality defect for this medicinal product nor information indicating that the suspected counterfeited medicine Pegasys might be on the market, therefore no concern.
Detailed information is accessible under the following link:

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Workshop on granting marketing authorisations for herbal medicinal products

29.10.2013

The Agency for Medicinal Products and Medical Devices (HALMED) is organising a half day workshop under the title “Workshop on granting marketing authorisations for herbal medicinal products”, for marketing authorisation holders. The workshop will take place on Friday, 6 December 2013 from 9 a. m.to 1 p.m. at HALMED’s premises, Ulica Roberta Frangeša Mihanovića 9 (Sky Business Office), 1st Floor, 10000 Zagreb.
All interested to participate may register via registration form that is accessible alongside on the HALMED webpages in the Lectures and workshops/Workshop on granting the marketing authorisation for herbal medicinal products section or under the following link.

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For Patients and Public

For Health Care Professionals

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