. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/PER/39 
14 February 2012 
 (12-0844) 
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 (Ministry of Foreign Trade and Tourism) 
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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 medicine, 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:   Proyecto de Decreto 
Supremo que Modifica Artículos de l Reglamento para el Registro, Control y Vigilancia 
Sanitaria de Productos Farmacéuticos, Di spositivos Médicos y Productos Sanitarios  
(Draft Supreme Decree amending certain artic les of the regulations on the registration, 
control and sanitary surveillance of pharmac eutical products, medical devices and sanitary 
products) (9 pages, in Spanish). 
6. Description of content:   The notified draft Supreme Decree contains four articles, 
one final supplementary provision and five transitional supplementary provisions which 
amend certain articles of the regulations on the registration, control and sanitary 
surveillance of pharmaceutical products, medi cal devices and sanitary products, approved 
by Supreme Decree No. 016-2011-SA, with a view to complementing the implementation of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products). G/TBT/N/PER/39 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:  
1. 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); 
2. Decreto Supremo Nº 016-2011-SA, que aprueba el Reglamento para el Registro, 
Control y Vigilancia Sanitaria de Produc tos Farmacéuticos, Dispositivos Médicos y 
Productos Sanitarios (Supreme Decree No. 016-2011-SA, which approves the 
regulations on the registration, control a nd sanitary surveillance of pharmaceutical 
products, medical devices and sanitary products); 
3. The publication in which the proposal will appear when adopted. 
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.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  
http://members.wto.org/crnattach ments/2012/tbt/PER/12_0589_00_s.pdf