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News

Agenda of the international regulatory and pharmacovigilance conference “Croatian Mark in the EU” available
28.10.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international regulatory and pharmacovigilance conference entitled "Croatian Mark in the EU” which will be held from 11 to 12 November 2013 in Hotel Ivan, Solaris, in Šibenik.

All interested for participation may register via registration form, which is, along with detailed information, accessible at the HALMED's webpages in the Conferences and workshops/Regulatory and pharmacovigilance conference "Croatian Mark in the EU" section, or under the link below.

[more]

Notice on potential risk of cracks in vials of Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)
27.10.2014.

GlaxoSmithKline, the marketing authorisation for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the potential incident of cracks of these medicine.

More information is accessible under the link below.

[more]

Recall of two batches of Ibustar for children 20 mg/ml oral suspension (ibuprofen)
24.10.2014.

Berlin-Chemie Menarini Croatia d.o.o., the marketing authorisation holder for Ibustar for children 20 mg/ml oral suspension (ibuprofen), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batches 32004 and 41005 of this medicinal product due to a discovered quality defect.

More information is accessible under the link below.

[more]

EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available
23.10.2014.

The European Medicines Agency (EMA) announced today in a press release that it was ready to start assessment of Ebola vaccines and treatments as soon as data were made available.

Over last several months the Agency has established a system that provides the best possible scientific advice to companies working currently on development of potential vaccines and/or treatments for fighting the Ebola virus. The Agency has also established a form of rolling review that allows experts to continuously assess incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process.

More information is accessible under the link below.

[more]

Notice on continuation of delivery of two Enbrel 25 mg powder and solvent for solution for injection batches
22.10.2014.

Following to the Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection, released on 8th October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the continuation of delivery of batches H58480 and H76658 of this medicine.

More information is accessible under the link below.

[more]

Workshop on OTC medicines: The Role of Good Classification Practices in Promoting Medication Safety and Accessibility in Europe
22.10.2014.

The workshop "The Role of Good Classification Practices in Promoting Medication Safety and Accessibility in Europe” will be organised by the Agency for Medicinal Products and Medical Devices (HALMED) and European Directorate for the Quality of Medicines and Healthcare (EDQM) from 20 to 21 November 2014 in Zagreb.
More information is accessible under the link below.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
Scope
Events - HALMED

Šibenik, 11-12 November 2014
International regulatory and pharmacovigilance conference "Croatian Mark in the EU"

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international regulatory and pharmacovigilance conference entitled "Croatian Mark in the EU" which will be held from 11 to 12 November 2013 in Hotel Ivan, Solaris, in Šibenik.

All interested for participation may register via registration form, which is, along with the agenda and detailed information, 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]