G/TBT/N/PER/82  
14 December 2015  
(15-6601)  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 [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, classified under Chapter 30 of the Harmonized 
System or Customs Tariff. 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Reglamento que regula la intercambiabilidad de medicamentos  (Draft Regulation on the 
interchangeability of medicines) (16 pages, in Spanish)  
6. Description of content: The notified draft Regulation contains 4 titles, 26 articles, 
12 final supplementary provisions and 1 annex, and establishes the regulatory provisions 
of Law No. 29459 - Law on pharmaceutical products, medical devices and sanitary 
products, in order to regulate the interchangeability of medicines. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health. 
8. Relevant documents:  
 Ley N° 29459 - Ley de los Productos Farmacéuticos, Dispositivos Médicos y 
Productos Sanitarios  (Law No. 29459 - Law on pharmaceutical products, medical 
devices and sanitary products); 
 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); 
 Decreto Supremo N° 017-2006-SA, que aprueba el Reglamento de Ensayos Clínicos 
en el Perú (Supreme Decree No. 017-2006-SA approving regulations on clinical trials 
in Peru); and 
 Decreto Supremo N° 006-2007-SA, que aprueba modificaciones al Reglamento de 
Ensayos Clínicos en el Perú (Supreme Decree No. 006-2007-SA approving 
amendments to the regulations on clinical trials in Peru). G/TBT/N/PER/82 
- 2 - 
  9. Proposed date of adoption: 180 calendar days after publication in the Official Journal El 
Peruano  
Proposed date of entry into force: 180 calendar days after publication in the Official 
Journal El Peruano  
10. Final date for comments: 9 March 2016 
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 - Perú 
Tel.: (+51-1) 513-6100, Ext. 8022 
Fax: (+51-1) 513-6100, Ext. 8002 Email: otc@mincetur.gob.pe  
http://www.comunidadandina.org/SIRT 
http://www.mincetur.gob.p e/reglamentostecnicos 
http://www.digemid. minsa.gob.pe/