. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/PER/29 
11 October 2010 
 (10-5207) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   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 [ ], 2.10.1 [X], 5.6.2 [ ], 5.7.1 [X], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.  
ICS numbers may be provided in  addition, where applicable):    
 
Pharmaceutical products:  Medicine, herbal medicine, dietary products and sweeteners, 
biologics and galenic products (classified under Chapter 30 of the Harmonized System or 
Customs Tariff); 
Medical devices (falling within tariff headi ngs 9018, 9019, 9021, 9022 and 9402 of the 
Harmonized System or Customs Tariff); 
Sanitary products:  Cosmetics, domestic hygi ene products and absorbent personal hygiene 
products (falling within the following tariff headings of the Harmonized System or Customs Tariff:  3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601). 
5. Title, number of pages and language(s) of the notified document:   Directiva 
Administrativa para la Certificación de Buenas  Prácticas de Manufac tura en Laboratorios 
Nacionales y Extranjeros (Administrative Directive on the certification of good 
manufacturing practices in domestic and forei gn laboratories) (18 pages, in Spanish). 
6. Description of content:   The notified Administrative Directive contains nine sections and 
three annexes.  It regulates the operati onal aspects of good manufacturing practice (GMP) 
certification audits of laboratories engaged in the manufacture of pharmaceutical products, 
medical devices and sanitary products, and establishes criteria and procedures for such certification. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health G/TBT/N/PER/29 
Page 2  
 
  8. Relevant documents:  
1. Publication in which the legislation appears:  Official Journal El Peruano . 
2. Ley Nº 29459 - Ley de los Productos Fa rmacéuticos, Dispositivos Médicos y 
Productos Sanitarios  (Law No. 29459:  Law on pharmaceutical products, medical 
devices and sanitary products). 
9. Proposed date of adoption: 
Proposed date of entry into force:  }The day following publication in the Official 
Journal El Peruano  
10. Final date for comments:   Not applicable 
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.digesa.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/2010/tbt/PER/10_3746_00_s.pdf