Comparison of the procedure for registration of medicines in the European Union and the Republic of Macedonia

Petkovska, Sofija and Zahkova, Danica and Gjorgjeska, Biljana (2015) Comparison of the procedure for registration of medicines in the European Union and the Republic of Macedonia. In: International Symposium at Faculty of Medical Sciences “Current achievements and future perspectives in medical and biomedical research”, 24 Nov 2015, Stip, Macedonia.

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Official URL: http://js.ugd.edu.mk/index.php/ISMS/article/view/1...

Abstract

Registration is a necessary step which follows every pharmaceutical preparation before being sent to the market and becoming available to patients. The approval follows two stages, the first clinical stage which provides security, safety and optimization of dosage integratively used in the four steps of clinical trials, and the second phase that provides marketing authorization. There are four agencies which operate with the procedure for approval and regulation of drugs: EU Legislation - Eudralex, European Directorate for the Quality of Medicines and Healthcare (EDQM), European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) in the European Union.

Item Type: Conference or Workshop Item (Poster)
Subjects: Medical and Health Sciences > Basic medicine
Medical and Health Sciences > Clinical medicine
Medical and Health Sciences > Health biotechnology
Medical and Health Sciences > Health sciences
Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Sofija Petkovska
Date Deposited: 01 Feb 2016 11:16
Last Modified: 01 Feb 2016 11:16
URI: http://eprints.ugd.edu.mk/id/eprint/15189

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