News and Educations

Adjustments to medicinal product information and risk minimization measures for medicinal products containing the active substances cyproterone acetate and ethinyl estradiol

13.06.2013

Summaries of the product characteristics and package leaflets of medicinal products containing cyproterone acetate and ethinyl estradiol will be aligned with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) endorsed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The recommendations are based on an assessment of the risks and benefits of the said medicinal products, published on the Agency for Medicinal Products and Medical Devices web site on 23 May 2013.

In the Republic of Croatia, marketing authorization has been granted for the following cyproterone- and ethinylestradiol-containing medicines:
1. Diane-35 coated tablets, marketing authorization holder Bayer d.o.o.
2. Bellune 35 coated tablets, marketing authorization holder Pliva Hrvatska d.o.o.
3. Axira 35 film coating tablets, marketing authorization holder Farmal d.d.

Detailed information can be found in the continuation of this notice.

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A seminar on

04.06.2013

Held from June 4 to 6, 2013, and jointly organised by the IRACM (Institute of Research against Counterfeit Medicine) and the French embassy in the Republic of Croatia, the seminar „Fighting against medicinal product counterfeiting” was inaugurated today at the Hotel Dubrovnik, Zagreb.

Employees of the Agency for medicinal products and medical devices (HALMED) actively participate in the event. Viola Macolić Šarinić, MD, PhD, the Head of HALMED, and Rajka Truban-Žulj, MPharm will introduce, on the second day of the event, the legal framework and current state of affairs in Croatia regarding the fight against counterfeit medicines.

Detailed information is available in the continuation of this info.

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New instructions for electronic ADR reporting in E2B standard (EudraVigilance)

28.05.2013

Agency for Medicinal Products and Medical Devices (HALMED) introduced on its web page new instructions for electronic ADR reporting in E2B standard (EudraVigilance). The instructions are available in the questions and answers form within the section Pharmacovigilance/Information for Marketing Authorisation Holders – Electronic Transmission of ICSRs/Electronic ADR reporting in E2B standard (EudraVigilance) – Questions and Answers, or under the link available in the continuation of this note.

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Important notice to Marketing Authorisation Holders and Clinical Trial Authorisation Holders in the Republic of Croatia on suspension of submitting SUSARs from the third countries to HALMED

27.05.2013

Marketing Authorisation Holders (MAHs) and Clinical Trial Authorisation Holders (CTAHs) in the Republic of Croatia are herewith informed that starting from 1 June 2013 the Agency for Medicinal Products and Medical Devices (HALMED) will cease to receive SUSARs from the third countries (EU and non-EU countries) involving medicinal products authorised for marketing in the Republic of Croatia or medicinal products in clinical trials in the Republic of Croatia seeing HALMED now has a direct access to EudraVigilance database of the European Medicines Agency (EMA), which makes all of these applications visible to the Croatian regulatory body for medicinal products, as well. Following the above, starting from 1 June 2013 Authorisation Holders must cease to submit SUSARs from the third countries to HALMED both electronically and in paper format.

Until 30 June 2013 Marketing Authorisation Holders must continue submitting to HALMED Individual Case Safety Reports (ICSRs) which have been created and submitted from the territory of the Republic of Croatia regardless of the seriousness of the suspected adverse reaction report (serious and non-serious) within 15 days from the date of receipt of the report. Starting from 1 July 2013 serious adverse reactions from the territory of the Republic of Croatia should be submitted to HALMED exclusively electronically within 15 days from the date of receipt of the report, while non-serious adverse reactions should be submitted within 90 days from the date of receipt of the report.

Clinical Trial Authorisation Holders should continue to electronically submit SUSARs from the clinical trials in the Republic of Croatia within 15 days (7 days respectively) from the date of receipt of the report. These reports stay in the national adverse reactions database and are not sent to EMA, whereas the Clinical Trial Authorisation Holder is obliged to submit them electronically to EudraVigilance CT module.

Detailed information can be found in the continuation of this notice.

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The retail sale of medicinal products in specialised shops

25.05.2013

In order to ensure the harmonization of the rules on where and how medicinal products can be sold and to provide transparent guidance for market authorisation holders, the Agency for Medicinal Products and Medical Devices shall establish, pursuant to the provisions set in the Medicinal Products Act and following the recommendations of the European Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), the criteria that medicinal products must meet in order to be sold over the counter in a pharmacy or a specialised shop. The said criteria shall first be set for single-component medicinal products and shall apply to all medicinal products approved in the Republic of Croatia.
The defined criteria for selling over the counter medicinal products containing ibuprofen and paracetamol are available on the HALMED web pages, under the section Medicinal Products/Over-the-counter (OTC) medicines/Retail sale in specialised shops, available in the continuation of this info.

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The benefits of Diane 35 and its generics outweigh the risks in certain patient groups

23.05.2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (VTE and ATE – the formation of blood clots in the veins and arteries). These medicines should be used solely for the treatment of moderate to severe acne related to androgen sensitivity or hirsutism (excessive unwanted growth of facial hair) in women of reproductive age, as is already stated in the Summary of Product Characteristics and the Package Leaflet approved in the Republic of Croatia for these medicines.

The new recommendations by PRAC are not very different to the information that has already been approved for Diane 35 and its generics in Croatia. Based on the consumption data, HALMED estimates that these medicines have been consistently prescribed for the approved indications and no off-label use has been noted. So far, HALMED has not received any reports of adverse drug reactions with fatal effects related to the use of Diane 35 and its generics.

Detailed information can be found in the continuation of this notice.

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The international conference on medicinal products regulation “EU28:science, medicines, health – a regulatory system fit for the future” started today in Dubrovnik

06.05.2013

The two-days international conference “EU28: science, medicines, health – a regulatory system fit for the future” was solemnly opened today. This conference has been jointly organised by the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED), under the auspices of the President of the Republic of Croatia, Prof. Ivo Josipović, PhD, and the Ministry of Health of the Republic of Croatia.
The conference has been supported by the IPA programme of the European Commission (Instrument for Pre-Accession Assistance programme), supporting, among others, the participation of candidate and potential candidate countries in the activities of European Institutions.
The conference was attended by about 250 participants – representatives from the civil service, public sector and pharmaceutical industry from EU Member States, Croatia, Albania, Bosnia & Herzegovina, Montenegro, Macedonia, Serbia and Kosovo under unscr 1244/99.

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New scientific confirmation of the low risk of Guillain-Barréovog syndrome associated with the use of pandemic flu vaccine in the vaccination season 2009/2010

02.05.2013

According to the results of an extensive meta-analysis conducted in the USA and recently published in The Lancet magazine, monovalent inactivated vaccines against pandemic influenza AH1N1 are associated with a minor risk of Guillain-Barréovog syndrome (GBS). The aim of the research was to ascertain how great a risk can be associated with the use of the aforementioned vaccines in relation to the expected number of GBS cases.

GBS is a rare autoimmune disorder in which a person’s own immune system damages their nerve cells, causing muscle weakness and paralysis. It is very often associated with colds and other infections of the upper respiratory system, the flu (seasonal or any other) and syndromes similar to the flu and some infections of the digestive system.

A comprehensive analysis of the safety risks associated with the use of the vaccines, funded by the American government, analysed data obtained from six adverse event monitoring systems that included information on 23 million vaccinated people in the USA. The incidence rate ratio (IRR) for the development of GBS was 2.35 (95% CI 1.42 -4.01, p = 0.0003). With the assumption that the background rate of GBS is one case per 100,000 people a year, the incidence rate ratio means translates to about 1.6 excess cases of GBS per million people vaccinated.

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