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News

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.

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EMA to review Inductos
24.07.2015.

The European Medicines Agency (EMA) has started a review of Inductos, an implant used in patients with spinal disc problems and leg fractures. This follows an inspection by Dutch and Spanish authorities which found the manufacturing site for one of the components of Inductos (the absorbable sponge) to be non-compliant with manufacturing requirements.

There is at present no indication of risk to patients linked to the inspection findings. This medicinal product is not placed on the Croatian market. EMA’s Committee for Medicinal Products for Human Use (CHMP) will now review the impact of the inspection findings on the product’s overall benefits and risks and make a recommendation as to whether any changes are needed to its marketing authorisation.

Further information is accessible under the link below.

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Notice on discontinuation in the supply chain with Virolex 30 mg/1 g eye ointment (acyclovir)
22.07.2015.

The marketing authorisation holder for Virolex 30 mg/1 g eye ointment (acyclovir), Krka – farma d.o.o., has notified the Agency for Medicinal Products and Medical Devices of a permanent discontinuation in the supply chain of the Croatian market with this medicine. The decision has been taken due to commercial reasons and in not related to quality, safety or efficacy of the medicine.

Virolex 30 mg/1 g eye ointment is indicated for the treatment of herpes keratitis. There is no other authorised medicinal product on the Croatian market of the same pharmaceutical form containing this active substance that is authorised for this indication. Therefore, HALMED will upon wholesaler’s request, for the treatment of patients in hospital settings or for patient named treatments, approve the enter of a medicinal product not having a marketing authorisation in Croatia.

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Notice to applicants for variations resulting from the referral for ibuprofen- and dexibuprofen-containing medicines
20.07.2015.

The Co-Ordination Group for Mutual Recognition Procedure and Decentralised Procedure fur Human Medicines (CMDh) endorsed on 20 May 2015 by consensus the recommendation by EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) for ibuprofen- and dexibuprofen-containing medicines and are intended for systemic use. The recommendation is endorsed under Art. 31 of Directive 2001/83/EC of the European Parliament and Council (procedure number EMEA/H/A-31/1401) following to the referral procedure.

Further information is accessible under the link below.

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Newly approved medicinal products
16.07.2015.

The list of newly approved medicinal products for the period between 1st June 2015 and 30th June 2015 is available in the continuation of this notice.

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Institute of Immunology proposed corrective actions on deficiencies discovered in inspections
15.07.2015.

Based on the Institute of Immunology’s application for granting manufacturing licenses for bacterial vaccines and manufacturing of blood and plasma derivatives and animal sera, in June 2015 HALMED conducted inspections in order to verify the GMP compliance.

Following to the inspection, Institute of Immunology d.d., submitted a written statement on discovered deficiencies with a proposal for corrective actions with deadlines for their implementation.

HALMED will reconsider the Institute of Immunology’s proposal and if needed, ask for additional justifications as well as evidence of undertaken measures. We would like to clarify that the deadline of 90 days until the HALMED’s decision does not count as long as the applicant has not submitted the requested justifications and evidence (clock-stop).

In spite of the public interest, we would like to emphasize that while these procedures are pending, no information could be provided as HALMED is bound to professional confidentiality.
HALMED will promptly inform the public on the results of procedures as soon as they have been completed.

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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]