LAW OF THE REPUBLIC OF MOLDOVA

of April 3, 2015 No. 53

About modification and amendments in the Law on drugs No. 1409-XIII for December 17, 1997

The Parliament adopts this organic law.

Art. I. – In the Law on drugs No. 1409-XIII for December 17, 1997 (Official monitor of the Republic of Moldova, 1998, Art. No. 52-53, 368), with subsequent changes, to make the following changes and addition:

1. In Article 61:

add Article with parts (2-1) and (2-2) following of content:

"(2-1) Price of the producer of drugs approved in lei can be reviewed by the Ministry of Health at the request of the applicant or on own initiative:

a) in case impairment more than for 5 percent of national currency in relation to the price currency brought in the National price catalog (dollar of the USA/euro) from the date of the publication of the order of the Minister of Health on price approval of the producer and preserving this change of the official average currency exchange rate within at least one month is established;

b) in case the rise in price on 3 and more than a percent of national currency in relation to the price currency brought in the National price catalog (dollar of the USA/euro) from the date of the publication of the order of the Minister of Health on price approval of the producer and preserving this change of the official average currency exchange rate within at least one month is established.

(2-2) Price of the producer of drugs brought in the National price catalog both in lei, and in currency, can be reduced at any time at the request of the applicant regardless of exchange rate fluctuations.";

in part (the words "in the Ministry of Health." shall be replaced with words 6) "in the Agency on drugs and medical products.".

2. In all text of the law of the word "The Agency on Drugs" shall be replaced with words "The agency on drugs and medical products" in the corresponding case.

Art. II. – To the government in three-months time to bring the regulations into accord with this law.

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