Data on testing pharmaceutical products to be protected by law in Moldova

Chisinau, 15 March /MOLDPRES/ - The law on pharmaceutical activity will be amended; thus, the state will establish a mechanism of protecting data on the testing of pharmaceutical, agro-chemical and phyto-sanitary products. The decree on the promulgation of these legislative amendments will be published in the 16 March issue of the Official Journal (Monitorul Oficial).    

A new mechanism of protection of data of testing pharmaceutical products for a define period of time will be established through the amendments operated. Thus, the innovating company which registers a product will hold exclusive right over the testing data. At the same time, the state authorities empowered with authorizing the product will refuse, on the protection period, the authorizing of generic medicines or identical chemical substances without the agreement of the authorization’s holder.    

To supply the domestic market with medicines, starting from 1 January 2020, the owners of original medicines, for which authorization of introduction on market is demanded, will benefit from a five-year-long period of protection of testing data and of additional two-year period of market exclusivity.

Concomitantly, on the period of protection of testing data for original medicines, any other producer will be able to make reference to the pre-clinical and clinical documentation in the file on medicine’s registration.  

The present law will enter into force on the date of its publication in Moldova’s Official Journal. The government will adjust its normative acts to the current law in a six-month period after the date of the document’s publication.   

(Reporter A. Zara, editor  M. Jantovan)