News and Educations

Basel hosts International Conference on Counterfeit Medicinal Products and Medical Devices

28.04.2010

During the Swiss chairmanship of the Council of Europe, an International Conference on Counterfeit Medicinal Products and Medical Devices was held in Basel on 15-16 April 2010. More than 140 senior healthcare, legislative and judicial officials from around 40 countries, international organisations and institutions took part, discussing practical implementation of the future Council of Europe MEDICRIME Convention.

The First Pharmaceutical Congress on the European Pharmacy Trends began in Priština

22.04.2010

The First Pharmaceutical Congress on the European Pharmacy Trends is under way in Priština, scheduled to last for two days. The Head of the Agency, Assist. Prof. Siniša Tomić, PhD, gave the following lecture at the Congress: Novelties in Croatian Regulatory Framework and Overview of Simplified Authorisation Procedure for EU Products in Croatia.

Recall of four lots of the medicinal product IMMUNINE 600 I.U. powder and solvent for solution for injection or infusion, of the manufacturer Baxter AG, Austria

15.04.2010

The Agency for Medicinal Products and Medical Devices recalled four lots of the medicinal product IMMUNINE 600 I.U. powder and solvent for solution for injection or infusion, the lots in question being VNC1J011-AA, VNC1J011-AB, VNC1J011-AC, and VNC1J011-AD, of the manufacturer Baxter AG, Austria, due to a suspected quality defect.

Newly approved medicinal products

14.04.2010

Here you can find a list of newly approved medicinal products between 1st March 2010 and 31st March 2010.

The Ordinance on Essential Requirements, Classification, Quality System, Entry into the Register of Manufacturers and the Register of Medical Devices and the Assessment of Conformity of Medical Devices

13.04.2010

The Ordinance on Essential Requirements, Classification, Quality System, Entry into the Register of Manufacturers and the Register of Medical Devices and the Assessment of Conformity of Medical Devices, was published in the Official Gazette No. 43/10 of 9 April 2010, coming into effect on the eighth day after publication, i.e. 17 April 2010.

E2B Implementation Status in the Republic of Croatia

08.04.2010

Under the Croatian law (Medicinal Products Act (Official Gazette No. 71/07), Act on the Amendments to the Medicinal Products Act (Official Gazette No. 45/09), and the Ordinance on Pharmacovigilance (Official Gazette No. 125/09)), reports of adverse drug reactions (ADRs) involving authorised medicinal products in the Republic of Croatia and the medicinal products in clinical trials in the Republic of Croatia, may be transmitted to the Agency for Medicinal Products and Medical Devices (HALMED) electronically.

The Agency's information system is ready to receive ADR reports from the Marketing Authorisation Holders (MAHs) in case of authorised medicinal products or from the Clinical Trial Authorisation (CTA) holders (Sponsors, SPs) by electronic transmission in line with the E2B (R2) standards through the EudraVigilance system.

New structure of the Agency

07.04.2010

At the meeting held on 24 March 2010, the Government of the Republic of Croatia gave its consent for the new Statute of the Agency for Medicinal Products and Medical Devices, whose adoption was necessary in order to harmonise the activity of the Agency with the current Medicinal Products Act and the Medical Devices Act.

The Statute provided for the new organisation of the Agency which will better support the Agency's public health function. The official abbreviation of the Agency's name is HALMED.

Publication of the new Ordinance on Good Practice, Conditions for Issuing Licence for the Wholesale Distribution and Import and Export of Medical Devices

06.04.2010

The Ordinance on Good Practice, Conditions for Issuing Licence for the Wholesale Distribution and Import and Export of Medical Devices was published in the Official Gazette No. 38/10 of 31 March 2010, coming into effect on the eighth day after publication, i.e. 8 April 2010.

Additional information on Rotarix vaccine

26.03.2010

The European Medicines Agency (EMA) at a special meeting of its Committee for Medicinal Products for Human Use held on 25 March 2010 concluded that the unexpected presence of the DNA fragments of a non-pathogenic virus strain in two lots of the oral vaccine Rotarix did not represent any public health concern and that no restrictions need to be put in place in connection with the use of this vaccine.

Press release concerning the new information on Rotarix vaccine

23.03.2010

The European Medicines Agency (EMA) issued a press release concerning the new information provided by GlaxoSmithKline Biologicals, manufacturer of Rotarix vaccine. The information concerns unexpected presence of porcine circo virus type 1 DNA (non-pathogenic virus strain) in two lots of the vaccine. This vaccine is often found in meat and other food products and it is not known to cause any disease in animals or in humans.

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