G/TBT/N/PER/81  
2 October 2015  
(15-5123)  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 language(s) of the notified document: Decreto Supremo 
que Modifica Artículos del Reglamento para el Registro, Control y Vigilancia Sanitaria de los 
Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios  (Supreme Decree 
amending certain articles of the regulation s on the registration, control and sanitary 
surveillance of pharmaceutical products, medical devices and sanitary products) (in 
Spanish) 
6. Description of content: The notified draft Supreme Decree contains five articles, one 
transitional supplementary provision and on e repealing supplementary provision that 
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:  
 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). G/TBT/N/PER/81 
- 2 - 
  9. Proposed date of adoption: The day following publication in the Official Journal El 
Peruano . 
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 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. 8040 
Fax: +(51-1) 513-6100, Ext. 8002 Email: otc@mincetur.gob.pe  
http://extranet.comunidadandina.org/sirt/public/index.aspx 
http://www.mincetur.gob.pe/ reglamentostecnicos/ 
http://www.digemid. minsa.gob.pe/ 
https://members.wto.org/crnattachments/2015/TBT/PER/15_3829_00_s.pdf