15.02.2012
Here you can find the list of medicinal products whose marketing authorisation was suspended or withdrawn in the period from January 1 to January 31, 2012.
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15.02.2012
Here you can find a list of newly approved medicinal products between 1st January 2012 and 31st January 2012.
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13.02.2012
Agency for Medicinal Products and Medical Devices (HALMED) posted on its website under the link For patients (in Croatian) a new column entitled „Use antibiotics responsibly and wisely“ that is dedicated to promoting the rational use of antimicrobial medicines.
HALMED monitors closely the use of antimicrobial agents in Croatia, calls for their rational and appropriate use and raises the public awareness on antibiotic resistance, because the incorrect and over-prescribing of antibiotics and their inappropriate use stimulate antimicrobial resistance and increase the risk of other diseases.
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13.02.2012
HALMED is a sponsor and participant in implementing the 4th Public Educational Campaign on Rational Use of Antimicrobial Medicines – JEKA“ with the aim to reduce the unnecessary or inappropriate use of antibiotics, because the over-prescribing of antimicrobial medicines stimulates the antimicrobial drug resistance and decreases the medicine effectiveness. The rational use of antibiotcs will preserve their activity and increase their clinical efficacy as well as decrease the potential for resistance development which will finally contribute to the decrease of morbidity and mortality due to infections by antibiotics resistent microorganisms.
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10.02.2012
The new opening hours of the registry Office will come into effect on February 13, 2012.
Customer service: from 8.00 a.m. to 3.30 p.m. Sample submission: from 8.00 to 2.00 p.m.
In case of submitting more than four applications, customers are kindly advised to make an advanced phone reservation on: +385 1 4884-162
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10.02.2012
As of February 1st, HALMED introduced a new internal organisation with the aim to improve the work processes and the effectiveness of the Agency. New processes will be introduced in steps into the existing ones and will be implemented in the next few months. We would like to inform our marketing authorisation/renewal/variation applicants that the applications submitted from January 1st will be handled according to new processes.
Applications submitted earlier, will be handled according to the existing processes. According to the new internal work share, type IA variations are handled independently from other variations. Therefore, we would kindly ask our applicants to submit type IA variations separately from other variation types. Exceptionaly, in case of more variations (type I or II), that are consequent of a one single variation, the applicant submits a single common application and a single variation application form. In that case, it is necessary to list all consecutive variations and explain their mutual linkage, pursuant to the Art. 21 of the Ordinance on Amendments to the Ordinance on the Procedure and Method for Granting Marketing Authorisation for Medicinal Products (Official Gazette No. 155/09).
We would kindly ask our applicants for their understanding with regard to the time schedule needed for introducing new processes to HALMED that will additionaly increase the speed and the quality of services provided to our customers.
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16.01.2012
Here you can find a list of newly approved medicinal products between 1st December 2011 and 31st December 2011.
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