Newly approved medicinal products
16.10.2015
The list of newly approved medicinal products for the period between 1st September 2015 and 30th September 2015 is available in the continuation of this notice.
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News and Educations
Notice on the recall of three batches of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)
14.10.2015
The Agency for Medicinal Products and Medical devices (HALMED) would like to inform on the recall of the batches B514AD and BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion of the marketing authorisation holder Medicuspharma d.o.o. from the Croatian market due to a suspected quality defect.
Further information is accessible under th elink bellow.
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Dear Healthcare Professional Letter on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib)
13.10.2015
Pfizer Croatia d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) would like to inform healthcare professionals on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib).
Further information and the Dear Healthcare Professional Letter is accessible under the link bellow.
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As of January 1st 2016 electronic Application Forms will be mandatory for all applications for granting a marketing authorisation, renewal, or variation
12.10.2015
The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform marketing authorisation holders on the beginning of use of electronic Application Forms (eAF) for applications for granting a marketing authorisation, renewal, or variation.
Further information is accessible under the link below.
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PRAC News – October 2015
12.10.2015
During its October meeting, the Pharmacovigilance and Risk Assessment Committee (PRAC) discussed three ongoing referrals in the EU. The PRAC did not initiate or conclude a safety referral.
Further information is accessible under the link below.
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Recommendations for reporting variations in the medicine documentation based on the signal safety review from the PRAC September 2015 Meeting available now
09.10.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages the recommendations for reporting variations in the medicine documentation based on the safety signal review adopted on the September 2015 Meeting of the European Medicines Agency’s (EMA’s) Pharmacovigilance and Risk Assessment Committee (PRAC) as well as Croatian translations of these recommendations. The recommendations concern the following active substances: alendronic acid, cholecalciferol, clodronic acid, etidronicl acid, ibandronic acid, neridronic acid, palmidronic acid, risedronic acid, tiludronic acid, zoledronic acid, leflunomide, thioctic acid and trabectedin. The recommendations are available in the Medicines/Instructions for MAHs regarding variation applications following PRAC recommendationsas safety signals Section.
When reporting a variation, marketing authorisation holders are obliged to use the adopted Croatian translation, whenever it is available and in this case, classify the variation as IAIN C.I.z. When submitting an application for variation, the marketing authorisation holder is obliged to quote the corresponding EPITT number as a procedure code.
When submitting an application for variation, the marketing authorisation holder is obliged to quote the corresponding EPITT number as a procedure code.
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Supplement 3.6 of Croatian Pharmacopoeia available now
05.10.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has released the sixth Supplement to the third on-line Edition of Croatian Pharmacopoeia designated 3.6. This Supplement is based on the sixth Supplement of European Pharmacopoeia released on 1st July 2015, coming into effect on 1st January 2016. The corrected texts published in European Pharmacopoeia 8.6 will come into effect at their release.
Further information is accessible under the link below.
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European Medicines Agency’s Management Board nominates Guido Rasi as Executive Director
01.10.2015
The European Medicines Agency’s (EMA’s) Management Board has nominated Professor Guido Rasi as the Executive Director of the Agency. At an extraordinary session on 1 October, the Board selected Professor Rasi from a shortlist of candidates provided by the European Commission. Professor Rasi has been invited to give a statement to the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on 13 October 2015. The appointment of the new Executive Director will only be made after this session.
Further information is accessible under the link below.
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CMDh News - September 2015
30.09.2015
At its September 2015 meeting, the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for Human Medicinal Products (CMDh) endorsed by consensus the PRAC recommendation for variations to marketing authorisations for several active substances.
The CMDh adopted the PRAC review conclusions for several active substances requiring changes in the product information or introduction of other risk minimisation measures.
Following the publication of the list of safety concerns per approved Risk Management Plans (RMPs) of active substances per product in April, the CMDh agreed to update the related cover note to provide guidance for Member States and MAHs on how to submit information for updates of the list. Templates for providing the information will also be made available.
Further information is accessible under the link below.
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European Commission celebrates 50th anniversary of the first pharmaceutical legislation in the EU
30.09.2015
On the occasion of the 50th anniversary of the adoption of the first pharmaceutical law in the EU, the European Commission organised a one day conference on 28th September in Brussels. The conference was attended by Viola Macolić Šarinić, MD, PhD, the Head of HALMED.
Further information on this conference and the Compendium of EU pharmaceutical law is accessible under the link below.
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