IP/N/1/MDA/14  
IP/N/1/MDA/U/3  
 
17 May 2022  
(22-3818)  Page: 1/2 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
 
NOTIFICATION OF LAWS AND REGULATIONS  
UNDER ARTICLE 63.2 OF THE TRIPS AGREEMENT  
REPUBLIC OF MOLDOVA : LAW AMENDING AND SUPPLEMENTING  
CERTAIN LEGISLATIVE ACTS NO. 24 OF 23.02.2018  
Notifying Member  REPUBLIC OF MOLDOVA  
 
Details of the notified legal text  
 
Title Law Amending and Supplementing Certain Legislative Acts No. 24 of 
23.02.2018  
Subject matter  Undisclosed information  
Nature of 
notification  [  ] Main dedicated intellectual property law or regulation  
[X] Other law or regulation  
Link to legal text* https://ip -documents.info/2022/IP/MDA/22_3452_00_e.pdf  
Notification status  [X] First notification  
[  ] Amendment or revision to notified legal text  
[  ] Replacement or consolidation of notified legal text(s)  
Previous 
notification(s) 
referred to  Not applicable  
Brief description of the notified legal text  
 
The notification is related to the am endments 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 shal l 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 b e 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 in dication/new indications.  
 
Language(s) of 
notified legal text English  
Entry into force  16 March 2018  IP/N/1/MDA/14 • IP/N/1/MDA/U/3  
 
- 2 - 
 
  Other date    
 
Notification details  
 
Submission date 
of notification  16 May 2022  
Other information  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)  
 
Agency or 
authority 
responsible  STATE AGENCY ON INTELLECTUAL PROPERTY OF THE REPUBLIC OF 
MOLDOVA (AGEPI)  
 
24/1 Andrei Doga st.  
MD-2024  
Chisinau  
Republic of Moldova  
 
Telephone :   (+373) 22400583  
Call-centre:   (+373)  22400500  
Fax:    (+373)  22440119  
Email:   office@agepi.gov.md  
Website :     www.agepi.gov.md  
 
 
 
* Links are provided to texts of laws and regulations notified under the TRIPS Agreement in the form 
supplied by the Member concerned; the WTO Secretariat does not endorse or revise their content.