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Law No. LP1409/1997 “On drugs”.

País/Territorio
Moldova, República de
Tipo de documento
Legislación
Fecha
1997 (2018)
Fuente
FAO, FAOLEX
Materia
Ganado, General
Palabra clave
Salud pública Procesamiento/manipulación Transporte/depósito Comercio internacional Investigación Envasado/etiquetado Sanidad animal Plagas/enfermedades Medicamentos
Área geográphica
CEI (Comunidad de Estados Independientes), Europa Oriental, Europa, Europa y Central Asia, Naciones en desarrollo sin litoral
Entry into force notes
This Law enters into force on the date of its official publication.
Resumen

The purpose of this Law is to ensure access of the population at the national level through the drug supply system to quality, effective and harmless medicines while maintaining affordable prices for them, preventing uncontrolled use of drugs. This Law applies in all areas of activity that have as object drugs: their research, registration, production, implementation in practice, application, import, export, storage, distribution, release, control. It does not apply to food additives, substances for external use for cosmetic purposes, for dietary and nutritional components for animals (vitamins, minerals, etc.). Ministry of Health, Labor and Social Protection has the right to bring the above-mentioned substances under the scope of this law, if they have some biologically active properties or have side effect on the human body. Medicines (medicines and preparations) shall be intended substances or mixtures of substances, authorized in accordance with the established procedure for manufacturing, import, export and use for treatment, alleviation, prevention and diagnosis of diseases, abnormal physical or mental condition or symptoms thereof in a person or animal, and also for restoration, correction and modification of their organic functions. Standards and requirements regarding the quality of drugs approved for application in the Republic of Moldova, are established by the Ministry of Health, Labor and Social Protection. The medicine must be of good quality and fit for the purpose. The medicine corresponds to its intended purpose if its use according to the instructions gives the expected effect and does not cause adverse reactions. The medicine must have a name that distinguishes it from other medicines, full description of the composition and the corresponding label. The Agency for Medicines and Medical Devices carries out: (a) examination, approval, registration of medicines, publication and maintenance of the State Register of Medicines; (b) control and supervision of the quality of medicines; (c) determining the conditions for licensing pharmaceutical activities in accordance with the acting legislation; (d) informing the population about medicines; (e) surveillance of side effects of drugs (pharmacovigilance); (f) standardization in the field of pharmaceutical activities; (g) issuing permits to import unregistered medicines for registration purposes; (h) permission to conduct and approve the results of clinical tests, supervision of their implementation; (i) statistics in the field of pharmaceutical activities and drug consumption; and (j) scientific and practical research in this area.

Texto completo
Ruso/Rumano
Página web
www.legis.md