of November 30, 2018 No. 312
About modification of some legal acts
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. Add Article 1 with concept of the following content:
"pharmaceutical safety - set of the measures directed to identification and the prevention of the potential hazards for health of the population caused by availability, inadequate quality, falsification of drugs, and also their misuse and/or use in the fraudulent purposes.".
2. Add Article 3 with part (4) the following content:
"(4) the Pharmaceutical companies and organizations perform the activities according to provisions of the Rules of proper practice approved by the Government.".
3. Add Article 18 with part (1-1) following contents:
"(1-1) For providing the population with the drugs Government approves the minimum range of the main and vital drugs, held for use in out-patient conditions which pharmaceutical warehouses and drugstores with open turnover shall have.".
4. To add Article 18-1 after subparagraph two with the subparagraph of the following content:
"-providing, if necessary, orphan medicines for treatment of patients with rare diseases;".
5. Add Article 20-1 with part (5) the following content:
"(5) the Certificate holder about registration of medicine and distributors of this medicine which is actually placed in the market in the Republic of Moldova provide within the powers necessary and continuous inventories of this medicine to drugstores and medical institutions so that needs of patients of the Republic of Moldova were covered.".
Art. II. - Article 5 of the Law on health protection No. 411/1995 (1995, No. 34, Art. 373), with subsequent changes, to add the official monitor of the Republic of Moldova with part (2/1) of the following content:
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