Leyes y reglamentos en el marco del párrafo 2 del artículo 63 del Acuerdo sobre los ADPIC - Ver detalles del documento

Moldova, Republic of
Law Amending and Supplementing Certain Legislative Acts No. 24 of 23.02.2018
The notification is related to the amendments made to the Law No.1456/1993 (see "Other information" below) on Pharmaceutical Activity introducing IP related measures relating to medicinal products for human use, namely for holders of an original medicinal product for which marketing authorization is requested which shall benefit from a 5-year period of data protection for preclinical and clinical trials from the date of authorization and an additional 2-year period of marketing protection for the medicinal product concerned. The 2-year period of market protection may be extended to a maximum of 3 years if, during the data protection period for tests and trials, the marketing authorization holder obtains an authorization for one or more new therapeutic indications thereof which, following a scientific evaluation prior to the authorization of the medicinal product, are considered to bring significant clinical benefits in comparison with existing therapies provided that significant preclinical tests and clinical trials are carried out and presented with regard to the new indication/new indications.
Text in Romanian - https://www.legis.md/cautare/getResults?doc_id=105763&lang=ro Law on pharmaceutical activity No.1456 of 25.05.1993: https://www.legis.md/cautare/getResults?doc_id=128121&lang=ro (Romanian) https://www.legis.md/cautare/getResults?doc_id=128121&lang=ru (Russian) Law on medicinal products No.1409 of 17.12.1997 https://www.legis.md/cautare/getResults?doc_id=115116&lang=ro (Romanian) https://www.legis.md/cautare/getResults?doc_id=115116&lang=ru (Russian)
STATE AGENCY ON INTELLECTUAL PROPERTY OF THE REPUBLIC OF MOLDOVA 24/1, Andrei Doga Str., Chisinau, MD2024, Republic of Moldova Tel.: (+373) 22400583 Call-center: (+373)22400500 Fax: (+373)22440119 Email: office@agepi.gov.md URL: www.agepi.gov.md