. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/PER/31 
10 January 2011 
 (11-0103) 
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 , MINSA  (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:  Medicine, herbal me dicine, dietary products and sweeteners, and 
biological and galenic products (classified under Chapter 30 of the Harmonized System or 
in the 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:   Reglamento para el 
Registro, Control y Vigilancia Sanitari a de Productos Farmacéuticos, Dispositivos 
Médicos y Productos Sanitarios (Regulations on the registration, control and sanitary 
surveillance of pharmaceutical products , medical devices and sanitary products)  
(162 pages, in Spanish) 
6. Description of content:   The notified text contains 283 articles, eight supplementary, 
transitional and final provisions and 6 annexes,  and establishes the regulatory provisions of 
Law No. 29459 on pharmaceutical products, medi cal devices and sanitary products, which 
govern the registration, control and surveilla nce of these products, in accordance with the 
National Medicinal Drug Policy. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health. G/TBT/N/PER/31 
Page 2  
 
  8. Relevant documents: 
Ley Nº 29459 - Ley de los Productos Farma céuticos, 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:  }180 days following its approval and 
publication in the Official Journal El Peruano  
10. Final date for comments:   4 April 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