13.04.2015
The European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) adopted new recommendations at its April 2015 meeting on use of high-dose ibuprofen and recommended additional measures in order to minimise the known risk of oseonecrosis of the jaw associated with use of zolendronic acid or denosumab.
Further information is accessible under the link below.
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13.04.2015
European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).
The PRAC concluded that the benefits of ibuprofen outweigh the risks but recommended updating advice on the use of high-dose ibuprofen to minimise the cardiovascular risk.
Further information is accessible under the link below.
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10.04.2015
PharmaMar S.A., marketing authorisation holder for Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin), has notified the Agency for medicinal Products and Medical Devices (HALMED) on the recall of the batch 14160 of this medicine due to a discovered quality defect. The quality defect consists of a risk of foreign particles in vials. As a precaution measure, further distribution and use of this batch is stopped in all hospital settings in the Republic of Croatia, where this medicine is used.The recall of this batch is being conducted at the hospital level.
Further information is accessible under the link below.
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09.04.2015
We hereby inform marketing authorisation applicants/holders that the information on the reporting system in the Republic of Croatia in the Summary of Product Characteristics and Package Leaflet should be indicated according to instructions for preparing product information available on the EMA’s webpages Quality review of Documents human-product information annotated template (English) version 9, or on the webpages of the Co-Ordination Group for MRP and DCP (CMD(h)) CMDh QRD annotated template for MRP/DCP. This concerns also marketing authorisations granted via national procedure.
Further information is accessible under the link below.
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02.04.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages recommendations for reporting variations in documentation based on the safety signal review from the March 2015 meeting of the European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC). Marketing authorisation holders are obliged to use the Croatian translation when reporting variations in documentation. The Croatian translation of recommendations is expected to be published in the second half of March 2015 on the HALMED webpages.
Further information is accessible under the link below.
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02.04.2015
At its March 2015, the Co-ordination Group for Mutual recognition and decentralised Procedure for Human Medicines (CMDh) has agreed by consensus PRAC recommendations for including new information in the summary of product characteristics and package leaflet for hydroxyzine-containing medicines due to the risk of effects on heart rhythm. In addition, it has been recommended that the interaction between broad spectrum antibiotics and combined oral contraceptives be deleted from the product information, for all concerned medicines, public assessment reports for paediatric authorisations have been adopted for applications submitted pursuant to Article 45 & 46 of the Paediatric Regulation and the Quick Response (QR) codes position paper has been revised.
Further information is accessible under the link below.
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01.04.2015
Under Medicinal Products Act (Official Gazette, No 76/13, 90/14), Ordinance on Pharmacovigilance (Official Gazette, No 83/13) and Ordinance on Clinical Trials and Good Clinical Practice (Official Gazette, No 25/15) the Agency for Medicinal Products and Medical Devices (HALMED) is responsible for authorising non-interventional studies.
Further information on submitting the documentation for applying and assessment of non-interventional trials is accessible under the link below.
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01.04.2015
We are hereby informing our customers that the Registry Office of the Agency for Medicinal Products and Medical Devices as of today, 1st April 2015, begins to work solely on one location, at Ksaverska cesta 4, Zagreb.
In accordance with this, as of 1st April 2015, at the location Ksaverska cesta 4, all mail, samples, documentation for medicines (authorisations, variations and renewals) , documentation for pharmacovigilance (including those regarding adverse reaction reporting from approved clinical trials: SUSAR, DSUR), medical device documentation and documentation for the Central Ethics Committee.
For submission of more than eight applications, an appointment should be made at 01/4884 162, 01/4884 163 and 01/4884 106.
Opening hours are from 8.00 a.m. to 3.30 p.m.
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31.03.2015
At its March 2015 meeting, the EMA’s Committee for Human Medicinal Products (CHMP) recommended five new medicines for approval, gave recommendation on extensions of indication for Tamiflu and adopted PRAC’s recommendations for Aclasta (zolendronic acid) that followed the periodic review of this medicine.
More information is accessible under the link below.
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26.03.2015
The Agency for Medicinal Products and Medical Devices (HALMED) completely supports efforts of Direction and employees of Institute of Immunology aimed at fulfilling all necessary conditions for regaining manufacturing licenses and fully supports the initiative aimed at helping Institute of Immunology. At the same time, HALMED is as an independent scientific body obliged by its action to protect primarily the most important national interest and this is the safety and health of our patients. Therefore, we decidedly reject implications that we have protected any particular private interest by rejecting manufacturing licenses to Institute of Immunology. HALMED was guided in its procedures solely by the interest of Croatian patients, which means their safety protection.
Institute of Immunology did not fulfil stipulated conditions and requirements of Good manufacturing Practice and it was not in the capacity of eliminating discovered deficiencies that might represent a public health risk, or health of every individual patient using medicinal products manufactured at these premises. Therefore, with the aim to protect Croatian patients, HALMED had to reject granting a renewal of these manufacturing licenses to Institute of Immunology.
We would like to stress that there is no question about “too strict” requirements, but rather about the same standard conditions and requirements that all other pharmaceutical manufacturers in Croatia fulfil, and that are indispensable for producing sterile medicinal products and vaccines. With the necessary improvement and investment, Institute of Immunology would be in capacity to fulfil them, as all other local manufacturers do.
In the case of the annulment of HALMED’s decisions on rejection of manufacturing licenses to Institute of Immunology, it is about different interpretations of the Medicinal Products Act and Act on the Common Administrative Procedure, that in the end has no influence on the scientific decision that Institute of Immunology at that time did not fulfil the manufacturing conditions. To support this is the fact that Institute of Immunology has never initiated any administrative court appeal against these HALMED’s decisions, which testifies that did not contradict the established situation according to which they do not fulfil the manufacturing conditions. Exactly opposite, even the Institute of Immunology’s Directorate at that time on several occasions publically confirmed the existence of discovered important and critical deficiencies that they were not in the capacity to remedy in order to fulfil the necessary prerequisites for renewal of manufacturing licenses.
When granting decisions on rejecting manufacturing licenses to Institute of Immunology, HALMED completely acted in accordance with the Medicinal Products Act and Act on Common Administrative Procedure. Based on all relevant facts, it was established 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 established by a scientific committee, composed from HALMED’s experts and the Ministry of Health’s pharmaceutical inspector.
The main objection to HALMED’s decisions is that they are allegedly founded on the opinion of the Ministry of Health’s pharmaceutical inspector, but rather opposite – they are based on the opinion of the legally responsible HALMED’s inspector and they are additionally referring to the opinion of the inspector who previously was the only inspector in Croatia. Namely, the procedure of granting/rejecting manufacturing licenses to Institute of Immunology was initiated before Croatia’s accession to the EU, when the GMP inspection was responsibility of the Ministry of Health. However, during the procedure, with the day of accession to the EU, the new medicinal Products Act came into effect, where the GMP inspection started to be part of HALMED’s responsibilities and the decision on rejection of manufacturing licenses to Institute of Immunology was based on the opinion of the responsible HALMED’s inspector.
It is a paradox that the fact that HALMED did not take account of its own inspector only, but rather included a scientific opinion of the Ministry’s inspector which is even more relevant when taking account of her long GMP inspection experiences, is considered to be a mistake. Also like the fact that the Report was not signed only by the HALMED’s inspector, but also by members of the Committee that the Agency under the relevant Ordinance was entitled to appoint.
The attempt to oppose the competency of the scientific Committee is completely wrong, because under Art. 26 the Ordinance clearly indicates that the Agency may appoint a committee composed of different experts, which the Agency in that case did, in order to support the scientific decision.
In addition, by incorrectly interpreting certain words in the opinion of the HALMED’s inspector and their pulling out of context in the Ministerial decision a wrong conclusion is indicated that the Agency’s inspector was possibly considering to grant a conditional license. However, just opposite, the Agency’s inspector in its opinion clearly states that 6 important deficiencies and even 2 critical ones, which means those that might put patients at risk, were discovered during the audit in Institute of Immunology.
Therefore, the opinion of the Agency’s inspector was completely in accordance with the Ministry’s pharmaceutical inspector, so the opinion of the Ministry’s inspector could have not changed the final decision. In other words, both these opinions are equally indicating the existence of critical deficiencies in manufacturing at Institute of Immunology, according to which licenses could have not been renewed or granted again.
We remind that Institute of immunology was already in 2012 granted conditional licenses with a one year deadline to remedy the discovered deficiencies. Bearing in mind that Institute of Immunology was not in the capacity to remedy the discovered deficiencies and ensure the relevant conditions for producing sterile vaccines and medicinal products, it was not possible to renew manufacturing licenses.
HALMED stays firmly behind this decision on rejecting manufacturing licenses that was taken completely in compliance with laws and bylaws and in compliance with our role as a an independent national regulatory body obliged to protect the interest of Croatian patients.
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