Analysis of the national market of unregistered medicines
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2024-04-14 22:42
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615.2:339.13.017(478) (2)
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DOGOTARI, Liliana, ZAMFIR, Ana, SOCHIRCĂ, Adrian. Analysis of the national market of unregistered medicines. In: Direcții de reformare a sistemului farmaceutic din perspectiva cursului european al Republicii Moldova, Ed. Ediția a 2-a, 28 aprilie 2023, Chişinău. Comrat: Universitatea de Stat din Comrat, 2023, Ediția a 2-a, pp. 97-98. ISBN 978-5-88554-205-0.
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Direcții de reformare a sistemului farmaceutic din perspectiva cursului european al Republicii Moldova
Ediția a 2-a, 2023
Conferința "Direcții de reformare a sistemului farmaceutic din perspectiva cursului european al Republicii Moldova"
Ediția a 2-a, Chişinău, Moldova, 28 aprilie 2023

Analysis of the national market of unregistered medicines

CZU: 615.2:339.13.017(478)

Pag. 97-98

Dogotari Liliana, Zamfir Ana, Sochircă Adrian
 
”Nicolae Testemițanu” State University of Medicine and Pharmacy
 
 
Disponibil în IBN: 16 mai 2023


Rezumat

Introduction. One factor influencing the quality, efficiency and safety of medicinal products on the pharmaceutical market lies with the authorization procedure. Medicines before being launched on the pharmaceutical market of the Republic of Moldova must go strictly through authorization procedures in order to prove their compliance with quality and safety standards. The authorization procedure of medicines and pharmaceutical products is a fairly complex one and requires certain conditions. The national pharmaceutical market is saturated with a number of names of medicinal products of domestic origin – about 10%, the rest, 90% belongs to their foreign manufacturers. Among the authorized medicines, the pharmaceutical market also contains a number of medicines, which are not authorized, but are imported in one of them in exceptional situations: rare diseases, calamities, epidemics, pandemics, war, etc. Aim of the study. Analysis and record keeping of medicines that are not registered in the Republic of Moldova, but are present and are used in the treatment and prophylaxis of inpatient patients in our country. Material and methods. The study was based on the analysis of bibliographical sources, the legislative framework regulating the procedure of authorization of medicines and import of unauthorized medicines, national data registers and pharmacotherapeutic forms of the Public Medical-Sanitary Institutions in Chisinau. Results. In exceptional cases, such as cataclysms, epidemics or the absence of analogues on the pharmaceutical market, the Medicines and Medical Devices Agency has the right to allow the import, distribution and use of unauthorized medicines and pharmaceutical products in the Republic of Moldova, but authorized in their country of origin. It is also allowed to be used as samples at the authorization stage, for preclinical research, bioequivalence studies and clinical trials, and at presentations of scientific manifestations of unauthorized medicinal products. The pharmaceutical market of the Republic of Moldova is currently also saturated with medicines that are not authorized in the Republic of Moldova, which proves the results of the evaluation of pharmacotherapeutic forms – 267 names of unregistered medicines. Conclusions. The pharmaceutical market of the Republic of Moldova is currently saturated with an increased number of non-authorized drugs – 267 names present in different medicinal forms, utilized in the treatment of the central nervous system – 23%, systemic anti-inflammatory use – 15%, cardiovascular, antineoplastic and immunomodulatory – 14%, blood and hematopoietic organs – 12%, muscular and skeletal – 9%, etc. From the names of unauthorized products, there are drugs of local origin, as well as names of drugs of foreign origin: 52 names of injectable and infusion solutions, 44 names of tablets, 3 names of ointments, etc.

Cuvinte-cheie
authorisation, unregistered medicines, pharmaceutical market