News and Educations

Institute of Immunology d.d. did not fulfil the conditions for manufacturing of sterile medicinal products and bacterial vaccines

25.03.2015

With regard to the annulment of HALMED’s decisions on rejection of manufacturing licenses to Institute of Immunology d.d. HALMED acted completely in accordance with the Medicinal Products Act and Act on the Common Administrative Procedure. Based on all relevant facts, it was concluded that Institute of Immunology d.d. at that time did not fulfil the conditions for producing sterile medicinal products and bacterial vaccines, which was unbiasedly discovered by a scientific Committee, composed of the Ministry of Health’s Pharmaceutical Inspector and HALMED’s experts.

Namely, in the case of the annulment of decisions, it is about different interpretation of the Medicinal Products Act and Act on the Common Administrative Procedure that in the end does not influence the scientific decision that Institute of Immunology at that time did not fulfil the conditions for manufacturing.

To support this, the fact that Institute of Immunology d.d. has never initiated an administrative appeal procedure against these HALMED’s decisions, which testifies that they did not contradict the established situation of having unmet manufacturing conditions.

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Notice on recall of one batch of Oronazol 20 mg/g shampoo

23.03.2015

Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for Oronazol 20 mg/g shampoo has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the recall of the batch EKB1Z00, EUR code: 6160803 from wholesalers and pharmacies. The recall is being conducted due to a batch labelled in Slovenian and mistakenly placed on the Croatian market during distribution.

This recall of the medicine labelled for the Slovenian market will not affect the regular supply chain with this medicine in Croatia.

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Dear Healthcare professional Letter on the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol

19.03.2015

Remedia d.o.o. , in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is sending a letter to healthcare professionals to inform them of the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol.

Further information is accessible under the link below.

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The European Medicines Agency celebrates its 20th anniversary

19.03.2015

On 18th March 2015 theEuropean Medicines Agency (EMA) celebrated the 20th anniversary of its establishiment. On this occasion, a scientific conference entitled “Science, Medicines, Health: Patients at the heart of future innovation conference”, where the EMA representatives together with representatives of academia, pharmaceutical industry, patient organisations, health technology assessment authorities, international competent authotrities, European Commission and EU members states medicines agencies discussed the best practices of providing support and shaping innovations in order to improve the health of patients in the EU. Viola Macolić Šarinić, MD, PhD, the Head of HALMED, joined the ceremony on behalf of the Croatian Agency for Medicinal Products and Medical Devices (HALMED).

Further information is accessible under the link below.

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PRAC recommends restrictions on the use of codeine for cough and cold in children

13.03.2015

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.

The PRAC recommended specifically that:
• Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
• Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
• All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.

Further information is accessible under the link below.

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Notice on returning of the batch of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion to the Croatian market

13.03.2015

Following to the Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, published on 14 November 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs on the returning of the batch 15HG229F1 of this medicinal product.

The procedure of discontinuation of the supply chain and use of this medicine was initiated as a precautionary measure, due to a suspected quality defect following to an allergic adverse reaction reported to HALMED.
Based on the conducted investigation and special quality control, HALMED concludes that the samples of the medicine comply to the specification with regard tested parameters. Following to these results, the temporary discontinuation of the supply chain and use of the batch 15HG2291 of this medicine is being alleviated and the existing stocks may be returned to distribution and use.

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Notice on pharmacovigilance fees payable for centrally and nationally authorised medicines

11.03.2015

The European Medicines Agency (EMA) has published on its webpages the explanation for fees payable to the EMA for monitoring the safe use of medicinal products authorised in the EU. This document describes the types of fees and exemptions from them and the procedure by which the EMA collects and charges fees from marketing authorisation holders of medicinal products.

Further information on pharmacovigilance fees is accessible under the link below.

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Visit of HALMED’s delegation to the Agency for Medicines and Medical Devices of Montenegro

06.03.2015

The delegation of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) headed by Dr Viola Macolić Šarinić, MD, PhD, Head of Agency, has visited the Agency for Medicines and Medical Devices of Montenegro (CALIMS). This visit has been organised within the co-operation of regional competent authorities in the field of medicines and medical devices stipulated by Memorandum on co-operation and understanding. On this occasion, the Head of HALMED, Dr Viola Macolić Šarinić, held a lecture on the local pharmacovigilance system and on HALMED’s co-operation with media.

Further information is accessible under the link below.

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