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News

Registration for the international regulatory and pharmacovigilance conference “Croatian Mark in the EU” started
26.09.2014.

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.

The registration for the conference started today, 26 September 2014. 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 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]

Head of the Croatian Agency at the 37th Annual Meeting of representatives of the National Centres participating in the WHO Programme for International drug Monitoring
20.10.2014.

The 37th Annual Meeting of representatives of the National Centres participating in the WHO Programme for International drug Monitoring was held from 14-17 October 2014 in Tianjin, China. This meeting was jointly organised by the World Health Organisation (WHO), WHO’s collaborative centre for adverse reaction monitoring, Uppsala Monitoring Centre (UMC), Chinese Food and Drug Administration (CFDA). The Head of the Croatian Agency, Viola Macolić Šarinić, MD,PhD and her co-workers also participated at the meeting. The meeting was attended by some 200 representatives of National centres from 54 countries worldwide participating in the programme.
More information is accessible under the link below.

[more]

Summaries of Risk Management Plans
20.10.2014.

The Agency for Medicinal Products and Medical devices (HALMED) is publishing on its webpages Summaries of Risk Management Plans
The summary of risk management plan is information on risks of use of an individual medicinal product written in a simple and comprehensible manner and proved and verified from the relevant competent authority. The summary of risk management plan is intended to healthcare professionals and patients or their carers who want relevant and evidenced based information on the most important risks associated with use of a certain medicine.

More information is accessible under the link below.

[more]

New category on medicinal product status in the medicinal product database on the HALMED webpages
20.10.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) has included in its medicinal product database on its webpages, a new category "Medicinal product is placed on the market in Croatia”. Every medicinal product in this database, in this field, depending on its status on the market may be allocated values like Yes, No, Shortage, Permanent discontinuation in the supply chain or Temporary discontinuation in the supply chain. The database may be searched by using one of these criteria.
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.

The registration for the conference started today, 26 September 2014. All interested for participation may register via registration form, which is, along with 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]