of July 20, 2023 No. 216
About modification of some regulations (optimization of activities of the National agency of public health)
The Parliament adopts this organic law.
Art. I. - In the Law on pharmaceutical activities No. 1456/1993 (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes to make the following changes:
1. Part (Article 14-1 to state 2) in the following edition:
"(2) the Basis for implementation of pharmaceutical activities is the license granted according to provisions of the Law on regulation of business activity by permission No. 160/2011 and with special regulations and also the certificate on compliance to proper practice of production of drugs for the person (Good Manufacturing Practice), the certificate on compliance to proper practice of distribution of drugs for the person (Good Distribution Practice) or the certificate on compliance to proper pharmaceutical practice (Good Pharmacy Practice), (further - certificates on compliance to proper practice). In value of this part:
a) proper practice of production of drugs for the person (Good Manufacturing Practice - GMP) - the system of quality assurance of drugs guaranteeing that products are steadily made and controlled according to the proper quality standards;
b) proper practice of distribution of drugs for the person (Good Distribution Practice - GDP) - the system of quality assurance of drugs guaranteeing maintenance of quality of drugs and/or active agents at all stages of supply chain against warehouse of the producer to drugstore or the supplier of medical services;
c) proper pharmaceutical practice (Good Pharmacy Practice - GPP) - the system of quality assurance of pharmaceutical activities performed by drugstores and directed to receipt of advantage for health of the person.".
2. Item e) parts (Article 14-2 to state 6) in the following edition:
"e) absence or response provided by part (2) Article 14-1 of the certificate on compliance to proper practice;".
3. Item g) Article 14-3 to state in the following edition:
"g) absence or withdrawal of the certificate on compliance to proper practice provided by part (2) Article 14-1.".
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