. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/PER/34 
10 June 2011 
 (11-2871) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Notifying Member:   PERU 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Ministerio de Salud  (Ministry of Health) 
Name and address (including telephone  and fax numbers, e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   Ministerio de 
Comercio Exterior y Turismo, MINCETUR  (Ministry of Foreign Trade and Tourism) 
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):   Pharmaceutical 
products:  medicines falling under Ch apter 30 of the Harmonized System 
5. Title, number of pages and language(s) of the notified document:   Directiva Sanitaria 
para la Presentación de la Información T écnica sobre Eficacia y Seguridad para la 
Inscripción de Medicamentos comprendidos en el Numeral 2 y reinscripción de los 
medicamentos comprendidos en el Numeral 2 y 3 del Artículo 10º de la Ley Nº 29459  
(Sanitary Directive governing the submission of  the technical information on effectiveness 
and safety required for the registration of medicines classified under point 2 and the re-registration of medicines classified under poi nts 2 and 3 of Article 10 of Law No. 29459) 
(7 pages, in Spanish). 
6. Description of content:   The notified Directive contains eight sections.  It establishes and 
defines the technical criteria for the techni cal information on effectiveness and safety 
required for the registration of category 2 me dicines and the re-registration of category 2 
and 3 medicines, as provided for in Artic le 10 of Law No. 29459 on Pharmaceutical 
products, medical devices and sanitary products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Ley Nº 29459 - Ley de los Productos Farmacéuticos, Dispositivos 
Médicos y Productos Sanitarios  (Law No. 29459 on Pharmaceutical products, medical 
devices and sanitary products). G/TBT/N/PER/34 
Page 2  
 
  9. Proposed date of adoption: 
Proposed date of entry into force:   To be determined 
6 months after publication in the Official 
Journal El Peruano  
10. Final date for comments:   29 August 2011 
11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers, e-mail and website addresses,  if available of the other body: 
Websites: 
http://www.comunidadandina.org/SIRT  
http://www.mincetur.gob.pe/reglamentostecnicos  
http://www.digemid.minsa.gob.pe/  
 
Ministerio de Comercio Exterior y Turismo - MINCETUR Calle Uno Oeste Nº 50, Urb. Corpac, Lima 27, Perú 
Tel.: +(51-1) 513-6100, Ext. 8022 
Fax: +(51-1) 513-6100, Ext. 8002 E-mail: otc@mincetur.gob.pe  
 
Text available online at: 
http://members.wto.org/crnattach ments/2011/tbt/PER/11_1780_00_s.pdf