News and Educations

HALMED celebrates 40 years of spontaneous adverse reaction reporting in Croatia

24.12.2014

The Republic of Croatia celebrates this year forty years of spontaneous suspected adverse reaction reporting. On this occasion that is important for monitoring the safe use of medicines, the Agency for Medicinal Products and Medical Devices (HALMED) has published on its webpages a number of informative texts posted in the occasional section “40 years of spontaneous ADR reporting in Croatia” to make users and patients more familiar with the importance and procedures of suspected adverse reaction reporting as well as with the system of monitoring the safe use of medicines in Croatia.

The new section is available in the Pharmacovigilance/40 years of spontaneous reporting in Croatia section of the HALMED's webpages. More information is accessible under the link below.

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Expert Workshop “OTC Medicines: the Role of Good Classification Practices in Promoting Medication Safety and Accessibility of in Europe” held in Zagreb

21.11.2014

The Expert Workshop “OTC Medicines: the Role of Good Classification Practices in Promoting Medication Safety and Accessibility of in Europe” was organised by the European Directorate for the Quality of Medicines and Health Care (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) from 20 to 21st November 2014 in Zagreb. Almost hundred participants from national and European competent authorities for medicines, healthcare professionals, patient organisations and pharmaceutical industry from even 19 countries involved in classification of medicines as regard their supply took part in the workshop.

Details are accessibe under the link below.

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Overview on International regulatory and pharmacovigilance conference “Croatian mark in the EU”

14.11.2014

The international regulatory and pharmacovigilance conference “Croatian mark in the EU”, was organised from 11 to 12 November in Šibenik by the Agency for Medicinal Products and Medical Devices (HALMED), under the auspices of the Croatian Ministry of Health. The conference was aimed at informing all stakeholders on medicines regulations that came into effect after Croatia’s accession to the EU with the aim to better harmonise with these requirements. A round table on counterfeit medicines and introduction of safety features was also held within the conference.

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Generic and original medicines – equally safe and efficacious

25.09.2014

The Agency for Medicinal Products and Medical Devices (HALMED) wants to provide hereby the information regarding the quality safety and efficacy of generic medicinal products in order to better clarify this issue:

Every medicinal product, regardless if it is an original or generic one, may be granted marketing authorisation and be accessible to patients, only if its safety and efficacy has been proved.

The generic medicinal product is a medicinal product containing the same amount of the same active substance as the original medicinal product acting in the same mechanism, same velocity and same efficacy as the original medicine. Generic medicines are equally well investigated and controlled as original medicines. Before being placed on the market, generic medicines must undergo bioequivalence studies, or clinical trials on patients where their equal efficacy to the reference original medicines must be proved.

The most important component of every medicine is its active substance. The active substance is a substance by which certain medicine achieves its therapeutic effect, it carries the therapeutic efficacy of the medicine. The generic medicine contains the same identical active substances in the same amount as the reference medicine, thus achieving an identical therapeutic effect. On the other side, in addition to the active substance, every medicine contains so called excipients without any therapeutic effect and therefore excipients may vary in certain generic medicines and their respective originals. So, only difference in the composition of generic and original medicines may be in their excipients used in their manufacturing, such as colours used to obtain different colouring of tablets to make them visually different, which is recommended for their easier differentiation. All these excipients of the generic medicine may obligatory fulfil the same criteria of quality and safety in the same manner as those in the original medicine.

Detailed information is accessible under the link below.

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Information on production material imported from the Republic of Korea in 2013

08.09.2014

Based on the newly received information, upon the Customs Office reported about infliximab, imported from the Republic of Korea, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to provide information related to the production material from the Republic of Korea in 2013, that attracts great interest from the Croatian public and media and is being incorrectly associated to the revocation of the Zagreb Institute of Immunology’s manufacturing license.
There were no finished medicinal products or human vaccines to be used in Croatian patients, or any other alternative to products of the Zagreb Institute of Immunology, but an intermediate product for manufacturing , was imported, more precisely the active substance infliximab that has never been manufactured by the Zagreb Institute of Immunology. The biological substance infliximab is a monoclonal antibody used in manufacturing of a new generation so called “clever” biological medicines and cannot be in neither way associated with the products by the Zagreb Institute of Immunology, hence this manufacturer has never been producing neither this substance nor medicinal products or any other medicinal product intended to treat patients with the same indication as infliximab. Therefore, we are highlighting once again that the import of blood products from the Republic of Korea in 2013, that attracted great interest from the public, has not been associated with the revocation of the Zagreb Institute of Immunology’s manufacturing license.
The large amount of the active substance was not imported from the Republic of Korea to the Republic of Croatia for the Croatian healthcare system, but for the needs of the entire EU and it was imported in Croatia, because a part of the manufacturing process of this medicine for the whole EU takes place in Croatia.

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European Commission launches logo for online pharmacies to protect patients from falsified medicinal products

30.06.2014

The European Commission has introduced a common logo for online pharmacies in the European Union enabling patients to recognise authorised online pharmacies and thus avoid the danger of buying falsified medicinal products. The logo will appear on the websites of legally operating online pharmacies in the EU confirming their authenticity and safety, i.e. confirming that the medicines they offer are of approved quality and are safe for use. The logo will lead the Croatian citizens to the website of the Agency for Medicinal Products and Medical Devices (HALMED), where all legally operating online pharmacies established in the Republic of Croatia will be listed. If the pharmacy is not listed therein, citizens are advised not to buy the medicines this way.

Detailed information is accessible under the link below.

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