G/TBT/N/PER/62
21 October 2014
(14-6057)  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: PERU 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible: Ministerio de Salud  (Ministry of Health) 
Name and address (including telephon e and fax numbers, email 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 provid ed in addition, where applicable):  
• Pharmaceutical products classified under Chapter 30 of the Harmonized System or 
Customs Tariff. 
• Medical devices classified under headings of the Harmonized System or Customs 
Tariff. 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Decreto Supremo que Modifica Artículos del Reglamento para el Registro, Control y 
Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios  (Draft Supreme Decree amending certain articles of the regulations on the 
registration, control and sanitary surveillance of pharmaceutical products, medical devices 
and sanitary products) (15 pages, in Spanish) 
6. Description of content: The notified draft Supreme Decree contains five articles, one 
transitional supplementary provision and on e repealing supplementary provision which 
amend certain articles of the regulations on the registration, control and sanitary 
surveillance of pharmaceutical products, medical devices and sanitary products, approved 
by Supreme Decree No. 016-2011-SA, with a vi ew to complementing the implementation 
of Law No. 29459 on pharmaceutical products, medical devices and sanitary products. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health. 
8. Relevant documents:  
1. Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary 
products) 
2. Decreto Supremo N° 016-2011-SA, Reglamento para el Registro, Control y 
Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios  (Supreme Decree No. 016-2011-SA, Regulations on the registration, 
control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products) G/TBT/N/PER/62 
- 2 - 
  9. Proposed date of adoption: - 
Proposed date of entry into force: -  
10. Final date for comments: Not applicable 
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:  
Ministerio de Comercio Exterior y Turismo - MINCETUR 
Calle Uno Oeste No. 50 - Urb. Corpac 
Lima 27 Peru 
Tel.: (+51-1) 513-6100, Ext. 8040 
Fax: (+51-1) 513-6100, Ext. 8002 Email: otc@mincetur.gob.pe  
http://www.comunidadandina.org/ 
http://www.mincetur.gob.p e/reglamentostecnicos 
http://www.digemid. minsa.gob.pe/ 
http://members.wto.org/crnattachments/2014/tbt/PER/14_4706_00_s.pdf