LAW OF THE REPUBLIC OF MOLDOVA

of February 23, 2018 No. 24

About modification and amendments in some legal acts

For the purpose of transposition of provisions of Articles 10, 10-a, 10-b and 10-c the Directive 2001/83/EU of the European Parliament and Council of November 6, 2001 about compiled laws of Community concerning medicines for the person published in the Official magazine of the European Union by L 311 of November 28, 2001

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 and amendments to make the following additions:

1. To add Article 1 after the concept "not approved medicine" with the following concepts:

"the data protection period - the period during which the holder of data on preclinical testing and clinical trials has the right to prohibit use of these data;

the period of market exclusivity - the period during which medicine generic cannot be entered on the market;

the first approval - for the first time the approval received anywhere in the world on original medicine;".

2. Add the law with Article 11-5 of the following content:

"Article 11-5. Data protection and market exclusivity of pharmaceutical products

(1) In departure from the legislation on trade secret and information access, without mentioning the legislation on protection of industrial property, holders of original medicine for which permission to its introduction to the market is asked, use from the date of issue of permission the five-year period of data protection about preclinical testing and clinical trials and the additional two-year period of market exclusivity of the corresponding medicine.

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