G/TBT/N/PRY/73  
29 January 2014  
(14-0499)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: Spanish  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Notifying Member: PARAGUAY 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible:  Ministerio de Salud Pública y Bienestar Social , MSPyBS 
(Ministry of Public Health and Social Welfare) 
Name and address (including telephone and fax numbers and email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Centro de Referencia de la OMC (WTO Reference Centre) 
Dirección de Organismos Económicos Multilaterales (Directorate of Multilateral Economic 
Organizations) 
Ministerio de Relaciones Exteriores (Ministry of Foreign Affairs) 
Palma casi 15 de Agosto Nº 594 Asunción, Paraguay 
Tel.: +595 21 493-657 
Email: snin@mre.gov.py  
3. Notified under Article 2.9.2 [X], 2. 10.1 [ ], 5.6.2 [ ],  5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided  in addition, where applicable): Medicines 
containing ketoconazole as a monodrug or in combination with other substances 
5. Title, number of pages and lang uage(s) of the notified document:  Reglamento 
Técnico Nº 321/2013 por el cual se suspenden la importación, fabricación, manipulación, distribución, comercialización y dispensación de los medicamentos que contengan en su 
formula la sustancia ketoconazol, como monodroga o en asociación, por vía oral 
(comprimidos y gotas)  (Technical Regulation No. 321/2013 suspending the importation, 
manufacture, handling, distribution, marketing and dispensation of medicines containing 
ketoconazole, as a monodrug or in combination with other substances, for oral ingestion 
(tablets or drops)). 
6. Description of content:  The notified Technical Regulation suspends, as a health safety 
measure, the importation, manufacture, distribution, marketing and dispensation of pharmaceutical preparations and magistral formulae containing ketoconazole, 
in isolation or in combination with other substances, for oral ingestion (tablets or drops). 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Health safety G/TBT/N/PRY/73 
- 2 - 
  8. Relevant documents:  
Articles 3 and 4 of Law No. 836/80 "Health Code" ( Ley Nº 836/80 Código Sanitario ) 
provide, respectively, that the Ministry of Public Health and Social Welfare is the highest 
State body in respect of health and key social welfare issues, and that authority in health matters is exercised by the said Ministry, which is responsible for implementing and enforcing the provisions of the Health Code and the regulations thereunder and is 
vested with the power to so do; 
Article 3.1 of Law No. 1.119/1.997 on "Health and other products" ( Ley Nº 1.119/1.997 
"De Productos para la Salud y Otros" ) provides for the creation of the National Health 
Monitoring Directorate ( Dirección Nacional de Vigilancia Sanitaria , DNVS) as the 
implementing agency, under the Ministry of Public Health and Social Welfare. 
9. Proposed date of adoption: 
Proposed date of entry into force:   17 December 2013 17 December 2013 
 
10. Final date for comments: - 
11. Texts available from: National enquiry point [X], or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Unidad de Coordinación del SNIN 
Ministerio de Industria y Comercio (MIC) Avda. Mariscal F. López 3333 Asunción, Paraguay 
Tel.: +595 21 616-3284 
Fax: +595 21 616-3084 Email: snin@mic.gov.py  
Text also available at: 
http://members.wto.org/crnattachments/2014/TBT/PRY/14_0342_00_s.pdf