News and Educations

Recommendations for reporting variations based on the safety review from the February 2015 PRAC meeting available now

05.03.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has made available on its webpages the recommendations for reporting variations based on the signal safety review adopted in the February 2015 meeting of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC). Marketing authorisation holders are obliged to use the adopted Croatian translation when submitting variation applications.

Further information is accessible under the link below.

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HALMED announces the start of its Registry Office's operating exclusively at location Ksaverska 4

05.03.2015

We inform all our applicants that as of 1 April 2015 the Registry Office of the Agency for Medicinal Products and Medical Devices (HALMED) will commence operating exclusively at one location – Ksaverska cesta 4, Zagreb. Starting from the said date, the HALMED’s Registry Office will cease operating at the location Ulica Roberta Frangeša Mihanovića 9 (Sky Office Tower).

As of 1 April 2015 all mail, samples, documentation for medicinal products (marketing authorisations, variations and renewals), documentation for pharmacovigilance (including that related to the authorised clinical trials; SUSAR, DSUR), documentation for medical devices and documentation for Central Ethics Committee should be delivered to the address Ksaverska cesta 4, HR-10 000 Zagreb.

More information is accessible under the link below.

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Follow-up notice on reported suspected adverse reactions to the Tetanus vaccine (adsorbed), Institute of Immunology, 1 dose in Bosnia & Herzegovina

04.03.2015

The Institute of Immunology d.d., marketing authorisation holder for the Tetanus vaccine (adsorbed), Institute of Immunology, 1 dose, has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the results of a quality control of the batch 78/3 of this vaccine with the expiry date by August 2015. The Institute of Immunology has received these results from the Agency for medicines and Medical Devices of Bosnia & Herzegovina within a conducted investigation following to suspected adverse reaction reports in Bosnia & Herzegovina, which was published on 31 December 2014 on the HALMED webpages.

It is concluded that the tested samples of the Tetanus vaccine (adsorbed) comply to the approved specification with regard to the tested parameters and therefore there are no obstacles to use other packs of the batch 78/3.

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Follow-up notice on the shortage of Diamox 250 mg tablets (acetazolamide)

03.03.2015

Following to the previous notice on the shortage of Diamox 250 mg tablets (acetazolamide) on the Croatian market, the marketing authorisation holder for this medicinal product, Medical Intertrade d.o.o. has notified the Agency for Medicinal Products and Medical Devices on the shortage prolongation.

The normalisation of the supply chain with Diamox 250 mg tablets is expected in June 2015. By that time, patients will be treated with a medicinal product without a Croatian marketing authorisation that will be entered into the country by using the legal exemption scheme.

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Notice on recall of Ramipril H Farmal 5 mg/25mg tablets (ramipril, hydrochlorothiazide)

02.03.2015

Farmal d.d., the marketing authorisation holder for Ramipril H Farmal 5 mg/25 mg tablets (ramipril, hydrochlorothiazide) has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch 140802 of this medicine due to a discovered quality defect. The quality defect relates to the labelling on the aluminium foil on blisters in Ramipril H Farmal 5 mg/25 mg tablets, where there is an incorrect product name Ramipril Farmal 5 mg tablets (ramipril) instead of Ramipril H farmal 5mg/25 mg tablets (ramipril, hydrochlorothiazide).

It is a pharmacy level recall.

Further information is accessible under the link below.

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Notice on temporary discontinuation in the supply chain and use of the batch BL10AD of Medioclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

02.03.2015

Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation in the supply chain and use of the batch BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid).

The procedure of discontinuation in the supply chain and use of this batch is being conducted following to a reported quality defect by a healthcare professional. The quality defect relates to appearance of an unusual colour of the diluted product (dark yellow solution colour).

Further information is accessible under the link below.

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New safety information on ambroxol- and bromhexine-containing expectorants

27.02.2015

The CMDh has endorsed by majority vote recommendations to update the product information for ambroxol- and bromhexine-containing medicines with information about the small risk of severe allergic reactions and severe cutaneous adverse reactions (SCARs). The medicines are widely available in the EU for use as expectorants (to help clear mucus from the airways).

Further information is accessibe under the link below.

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CHMP News – February 2015

27.02.2015

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended three new medicines for granting a marketing authorisation and six medicines for extensions of therapeutic indications. In addition, following the CHMP’s January 2015 recommendations to suspend marketing authorisations of a number of medicines for which authorisations were primarily based on clinical studie conducted at GVK Biosciences, some marketing authorisation holders have requested a re-examination.

Further information is accessible under the link below.

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New instructions to marketing authorisation holders for variations applications based on the PRAC recommendations following a signal safety review

26.02.2015

Following the Pharmacovigilance Risk Assessment Committee (PRAC) January 2015 meeting, the European Medicines Agency (EMA) is publishing on its webpages translations of all texts in the EU official languages that should be included in the product information and that are related to medicines authorised via national or centralised procedure. When applying for a variation, marketing authorisation holders are obliged to use the adopted Croatian translation that is available on the HALMED's webpages.

Further information is accessible under the link below.

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Notice on the prolongation of deadline for reporting medicines consumption data

25.02.2015

Under the provision of the Ordinance on the data type and procedure for preparing medicines consumption reports (Official Gazette, No 122/14), all natural and legal persons that carry out wholesale of medicinal products and legal or natural persons that carry out retail of medicinal products are obliged by 1 March this year to submit to HALMED the medicines consumption data for the previous year.
Due to an increased number of enquiries that HALMED has received about the use of the Farmakoekonomika application and information medicines codes from the HALMED code, it is decided to prolong the reporting deadline by 31March 2015.

Further information and links to the web service farmakoekonomika, where the data on certain medicines codes may be checked as well as to the application by which reports should be submitted are accessible under the link below.

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