Moldovan state to establish mechanism of protecting data on testing pharmaceutical products

Chisinau, 23 February /MOLDPRES/ – The national legislation on protection and confidentiality of data in registration, testing and approval procedures for pharmaceutical, agrochemical and phytosanitary products was linked to the European one. A draft law was adopted in a final reading with the vote of 51 MPs today.

Following legislative changes, the innovative company registering a pharmaceutical, agrochemical or phytosanitary product will have the sole right to test data and state authority empowered to authorize the product will refuse to authorize generic medicines or identical chemicals without consent of the authorization holder.

Also, during the protection period of the original medicine test data, any other manufacturer may refer to preclinical and clinical documentation contained in registration file of the medicinal product.

Under the law, as of 01 January 2020, holders of the original medicinal products for which marketing authorization is requested will benefit from a five – year test data protection period and additional two – year exclusivity period on the market. In this way, new medicine manufacturers will be stimulated to come to Moldovan market.

(Reporter A. Zara, editor L. Alcaza)