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News

Presentations from the workshop „OTC Medicines: The role of good classification practices in promoting medication safety and accessibility in Europe“
27.01.2015.

The Council of Europe's European Directorate for the Quality of Medicines and Healthcare (EDQM) has publishedon its website presentations held at the workshop "OTC Medicines: The role of good classification practices in promoting medication safety and accessibility in Europe".

More information is accessible under the link below.

[more]

Notice on quality defect of batches 1280064, 1281064, 1282064, 1283064 of Soludeks 40, 100 mg/ml solution for infusion
27.01.2015.

The Croatian Institute for Transfusion Medicine, the marketing authorisation holder for Soludeks 40, 100 mg/ml solution for infusion has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of batches 1280064, 1281064, 1282064, 1283064 of this medicine.

More information is accessible under the link below.

[more]

Results of the annual survey on HALMED's customers satisfaction
26.01.2015.

The Agency for Medicinal Products and Medical Devices (HALMED) has published on its webpages the results of the annual survey on customers satisfaction. Once a year HALMED carries out this investigation with the aim of continuous improvement of services and follow up of users needs. In the survey carried out in October 2014, the majority of participants evaluated HALMED with high grades (excellent and very good).

More information is accessible under the link below.

[more]

CHMP News – January 2015
23.01.2015.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended seven new medicines for granting a marketing authorisation, seven medicines for extensions of therapeutic indications and concluded the review of the GVK Biosciences investigation site.

More information is accessible under the link below.

[more]

Temporary suspension of placing on the market of nine medicinal products due to non-compliance with the good clinical practice
23.01.2015.

Based on recommendations of the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices (HALMED) temporarily suspended the placing on the market of nine medicinal products in Croatia due to non-compliance with the good clinical practice. The clinical trials based on which the concerned medicinal products are authorised were carried out by GVK Biosciences at the investigational site in Hyderabad in India. Based on the fact that an inspection at the site discovered non-compliances with the good clinical practice rules, this temporary decision will be in effect until marketing authorisation holders have submitted new data, or carried out new trials on other sites.

In addition to the temporary suspension of placing on the market of these medicines, those medicines already on the market are being recalled to the pharmacy level.

This temporary suspension of placing on the market and recalls are being carried out as a precaution measures and are not initiated by safety reasons.

The list of medicines affected by the temporary suspension in Croatia is accessible here.

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Notice on increased number of applications that may be submitted without previous appointment to the HALMED Registry Office
21.01.2015.

We inform all users of our services that as of 22 January 2015, it is possible to submit no more than 8 applications without previous appointment. The number of applications that may be submitted without appointment to the HALMED's Registry Office is increased from four to eight based on the proposal of our users from the survey on HALMED's customers satisfaction.

More information is accessible under the link below.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
Web-Eadr
Scope
Events - HALMED

Zagreb, 10 and 11 February 2015
The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates

The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates will be organised from on the 10 and 11 February 2015 in Zagreb.

Details on fees, venue of the workshop and registration are accessible in the registration form by which all interested participants may register. The workshop programme 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]