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News

HALMED invites all general practitioners, pharmacists and cardiologists to participate in the survey on HCPs' opinions and views on safety communications
19.08.2015.

The Agency for Medicinal Products and Medical Devices (HALMED) in collaboration with Croatian Society of Family Physicians (HDOD), Croatian Pharmaceutical Society (HFD) and Croatian Cardiac Society (HKD) has initiated a survey on views of healthcare professionals on how competent authorities, like HALMED in Croatia, communicate new safety issues related to use of medicines to healthcare professionals.

As a result of HALMED’s efforts, the Republic of Croatia has been chosen among other Member States to participate in conducting this survey within the SCOPE aimed at providing a possibility to healthcare professionals to express their opinions and views on safety communications. Other participating countries are Spain, United Kingdom, Ireland, Italy, Sweden, the Netherlands, Norway and Denmark. The survey is part of a broader pharmacovigilance EU project entitled SCOPE (Strengthening Collaboration for Operating Pharmacovigilance in Europe) aimed at improving the health safety of patients in the EU, by promoting co-operation among member states and providing support to medicines regulatory agencies in meeting the requirements of the EU pharmacovigilance legislation. In line with the settings of the SCOPE project, HALMED invites all general practitioners, pharmacists and cardiologists to participate in the survey as target groups.

The aim of this survey is to examine experiences of healthcare professionals with safety communication by the medicines regulatory agencies, as well as their views on the effectiveness of such communication, and to identify healthcare professionals’ preferred communication channels.

More information on the survey and direct access are available under the link below, as well as on the webpages of Croatian Society of Family Physicians (HDOD), Croatian Pharmaceutical Society (HFD) and Croatian Cardiac Society (HKD).

[more]

Lecture „Regulatory procedures following the granting of the marketing authorisation“ within the Section for pharmaceutical regulations of the CPS
27.08.2015.

Ms Jasna Ikić Komesar, MPharm, from the Agency for Medicinal Products and Medical Devices will hold a lecture "Regulatory procedures following the granting of the marketing authorisation" within the Section for pharmaceutical regulations of the Croatian Pharmaceutical Society (CPS). The lecture will be held on Tuesday, 15 September 2015 at 6.00pm at the premises of the CPS, Masarykova 2/II, Zagreb.

We invite the marketing authorisation holders and other interested parties who find the news in this field helpful in their work to attend this lecture.

[more]

Follow-up notice on preventive recall of three batches of medicinal product Betrion mast (mupirocin)
25.08.2015.

Following the increased public interest on recall of three batches of medicinal product Betrion mast (mupirocin), which HALMED reported about on 19 August 2015, we would like to inform the following:

Recall of batches No. 331104, 332104, 131084 of the medicinal product Betrion mast carried out by Pliva Croatia d.o.o., the marketing authorisation holder, has been conducted preventively to the wholesale level.

The recall was carried out due to suspicion that the active substance mupirocin, batch W656993, which was used in the production of batches listed above, might have been contaminated by penicillin during the manufacturing. However, examination of indicated batches of medicinal product did not show presence of any penicillin component. Therefore, the decision to recall the medicine to the level of wholesale has been made as a precautionary measure.

This suspected quality defect cannot cause serious health consequences for patients. Pharmacies may continue to issue the remaining supplies of these batches of medicinal product. Patients can continue to use batches listed above and there is no need for returning previously issued packagings of this medicinal product to pharmacies.

[more]

Recall of three batches of the Betrion mast (mupirocin)
25.08.2015.

Company Pliva Hrvatska d.o.o., the marketing authorisation holder of the Betrion mast (mupirocin), has notified Agency for Medicinal Products and Medical Devices (HALMED) about the recall of batches no. 331104, 332104, 131084 of this medicinal product, due to suspected quality defect.

The suspicion in quality defect is based on potential penicillin contamination of active substance batch no. W656993 which has been used in production of mentioned batches. The recall is carried out to the level of wholesales.

[more]

Newly approved medicinal products
19.08.2015.

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

[more]

CHMP News – July 2015
24.07.2015.

At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU) and therefore outside Croatia. In addition, ten new medicines have been recommended for approval, as well as four recommendations on extensions of therapeutic indication. The marketing authorisation holder for Heparesc has requested a re-examination of the CHMP’s June 2015 negative opinion and a review of Inductos has started.

Further information is accessible under the link below.

[more]

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

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.

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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]

Cooperation with CPS

Lecture „Regulatory procedures following the granting of the marketing authorisation“ wi
Zagreb, 15 September 2015

Ms Jasna Ikić Komesar, MPharm, from the Agency for Medicinal Products and Medical Devices will hold a lecture "Regulatory procedures following the granting of the marketing authorisation" within the Section for pharmaceutical regulations of the Croatian Pharmaceutical Society (CPS). The lecture will be held on Tuesday, 15 September 2015 at 6.00pm at the premises of the CPS, Masarykova 2/II, Zagreb.

We invite the marketing authorisation holders and other interested parties who find the news in this field helpful in their work to attend this lecture.

[more]