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News

Tender for selling of housing container
16.04.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) is inviting tenders for selling of a basic asset:
-Housing container, Inventary No 001923/800272
Further information is accessible under the link below

[more]

Opening hours of the HALMED Registry Office on 18th April 2014
16.04.2014.

We inform all our clients that the Registry Office of the Agency for Medicinal Products and Medical Devices will be opened from 8.00 to 12.00 h on Friday, 18th April 2014.

[more]

Note to healthcare professionals about falsified Herceptin in the EU
16.04.2014.

The European Medicines Agency (EMA) has been informed about the vials of the cancer medicine Herceptin (trastuzumab). It is thought that these vials have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some Member States.
The numbers of suspected batches are H411B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H427B01, H4301B09 and H4303B01. None of these batches is present on the Croatian market.
Further information is accessible under the link below.

[more]

PRAC News – April 2014
15.04.2014.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review and started four new safety reviews at its meeting in April 2014.
Further information is accessible under the link below.

[more]

Dear Healthcare Professional letter on the new list of devices compatible for blood glucose level determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin)
09.04.2014.

The company Agmar d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new list of devices compatible for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin). The letter contains the new list of devices for blood glucose determination permitted to be used in those patients. The letter follows up to the previous letters addressed to doctors, that HALMED reported on its webpages in June 2008, July 2010 and August 2011.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

[more]

Newly approved medicinal products
16.04.2014.

The list of newly approved medicinal products for the period between 1st March 2014 and 31st March 2014 is available in the continuation of this notice.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
 	Informal PRAC Meeting
Events - HALMED

Workshop: “Regulatory framework in medicinal products distribution”

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb, a one day workshop “Regulatory framework in medicinal products distribution” intended to wholesales authorisation holders. Workshops will be held at HALMED’s premises, Ksaverska cesta 4. The exact date of the first workshop will be announced later, depending on the number of registered participants.
Further information is available under the link below.

[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

Vienna, 25-27 March 2014
Conference:”26th Annual DIA EuroMeeting”

The Conference ”26th Annual DIA EuroMeeting” will be held from 25 – 27 March 2014 in Vienna, organised by Drug Information Association (DIA).

Additional information is available under the link below.

[more]