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News

Notice on the beginning of the work of the HALMED Registry Office solely on one location
01.04.2015.

We are hereby informing our customers that the Registry Office of the Agency for Medicinal Products and Medical Devices as of today, 1st April 2015, begins to work solely on one location, at Ksaverska cesta 4, Zagreb.

In accordance with this, as of 1st April 2015, at the location Ksaverska cesta 4, all mail, samples, documentation for medicines (authorisations, variations and renewals) , documentation for pharmacovigilance (including those regarding adverse reaction reporting from approved clinical trials: SUSAR, DSUR), medical device documentation and documentation for the Central Ethics Committee.

For submission of more than eight applications, an appointment should be made at 01/4884 162, 01/4884 163 and 01/4884 106.

Opening hours are from 8.00 a.m. to 3.30 p.m.

[more]

Newly approved medicinal products
17.04.2015.

The list of newly approved medicinal products for the period between 1st March 2015 and 31st March 2015 is available in the continuation of this notice.

[more]

Dear Healthcare Professional Letter on the new list of compatible appliances for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin)
14.04.2015.

Agmar d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a Dear Healthcare Professional Letter on the new list of compatible appliances for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin).

Further information is accessible under the link below.

[more]

PRAC News – April 2015
13.04.2015.

The European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) adopted new recommendations at its April 2015 meeting on use of high-dose ibuprofen and recommended additional measures in order to minimise the known risk of oseonecrosis of the jaw associated with use of zolendronic acid or denosumab.

Further information is accessible under the link below.

[more]

PRAC recommends updating advice on use of high-dose ibuprofen
13.04.2015.

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).

The PRAC concluded that the benefits of ibuprofen outweigh the risks but recommended updating advice on the use of high-dose ibuprofen to minimise the cardiovascular risk.

Further information is accessible under the link below.

[more]

Workshop: “Regulatory framework in medicines distribution”
13.04.2015.

A workshop "Regulatory framework in medicines distribution” will be held in Zagreb and organised by the Agency for Medicinal Products and Medical Devices (HALMED). The workshop will be held in May 2015 at HALMED’s premises, Ksaverska cesta 4. The exact dates of the workshop will be announced later, depending on the number of registered participants.

Further information is accessible under the link below.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
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Events - HALMED

Workshop: “Regulatory framework in medicines distribution”

A workshop “Regulatory framework in medicines distribution” will be held in Zagreb and organised by the Agency for Medicinal Products and Medical Devices (HALMED). The workshop will be held in May 2015 at HALMED’s premises, Ksaverska cesta 4. The exact dates of the workshop will be announced later, depending on the number of registered participants.

[more]

Rovinj, 21-24 May 2015
5th Croatian Congress on Pharmacy with International Participation

The Croatian Pharmaceutical Society organises in collaboration with the Faculty of Pharmacy and Biochemistry and the Agency for Medicinal Products and Medical Devices (HALMED) the 5th Croatian Congress on Pharmacy with International Participation that will be held from 21 to 24 May 2015 in Rovinj.

More information is accessible 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

Leiden, The Netherlands, 24-24 April 2015
Conference on patient reporting: Current perspectives and future possibilities

The Netherlands Pharmacovigilance Centre Lareb, WHO collaborating Centre for Pharmacovigilance in Education and Patient Reporting is organising a conference on patient reporting entitled Current perspectives and future possibilities.
The conference deals with the following topics: the role of the patient in pharmacovigilance, added value of patient reporting in pharmacovigilance, maintenance, development and promotion of patient reporting system-

Further information is accessible under the link below..

[more]