G/SPS/N/MDA/10  
 
17 May 2019 
(19-3457) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  REPUBLIC OF MOLDOVA  
If applicable, name of local government involved:   
2. Agency responsible:  National Food Safety Agency (ANSA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Veterinary medicine products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Parliament Law No. 119 from 5 July 2018 regarding 
veterinary medicine products . Language(s):  Romanian . Number of pages:  26 
http://lex.justice.md/md/376819%20/  
6. Description of content:  This law establishes the conditions and procedure for the 
registration, manufacture, import, export, storage, distribution and rel ease of veterinary 
medicinal products for the purpose of their placement on the Republic of Moldova's 
market.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : - 
[X] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
− Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2018  
− Section 1.1  
o Chapter 1.1.8 – Principles of veterinary vaccine production  
o Chapt er 1.1.9 – Tests for sterility and freedom form contamination of 
biological material intended for veterinary use  
− VICH Guidelines  
[ ] International Plant Protection Convention (e.g.  ISPM number) : - 
[ ] None  
Does this proposed regulation conform to the relev ant international standard?  
[X] Yes   [  ] No G/SPS/N/MDA/10  
 
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  If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are available:   
The regulation was approved in the context of harmonization of the national legislation 
with EU  acquis communautaire : 
− Directive 2001/82 on the Community code relating to veterinary medicinal products;  
− Directive 2006/130 as regards the establishment of criteria for exempting certain 
veterina ry medicinal products for food -producing animals from the requirement of a 
veterinary prescription;  
− Regulation 540/95 establishing procedures for communicating suspected unexpected 
adverse reactions that are not serious which appear either in the Community  or in a 
third country to authorized medicinal products for human or veterinary use;  
− Regulation 1662/95 laying down certain detailed arrangements for implementing the 
Community decision -making procedures in respect of marketing authorisations for 
products for human or veterinary use.   
10. Proposed date of adoption (dd/mm/yy) : 5 July 2018  
Proposed date of publication (dd/mm/yy) : 17 February 2018  
11. Proposed date of entry into force: [X]  Six months from date of publication , 
and/or  (dd/mm/yy) :  
[X] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 16 July 2019 
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry  Point. Address, fax number and e -mail address 
(if available) of other body:   
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Mrs Diana Gherman  
Head of International Relations Department  
National Food Safety Agency  of the Republic of Moldova  
Tel: +(373 22) 29 47 09  
E-mail: diana.gherman@ansa.gov.md  
 
Ms Elena Cravet  
Trade Regimes and bilateral economic cooperation  
National Notification Auth ority 
Ministry of Economy and Infrastructure of the Republic of Moldova  
Chișinău, Piața Marii Adunări Naționale 1. MD - 2033 
Tel: +(373 22) 250 639  
E-mail: elena.cravet@mei.gov.md   
http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=376819