G/TBT/N/PER/94  
19 May 2017  
(17-2729) 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 government involved (Articles 3.2 and 7.2):   
2. Agency responsible : Ministerio de Salud  (Ministry of Healt h) 
Name and address (including telephone 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 classified under Chapter 30 of the Harmonized System or 
Customs Tariff . 
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Reglamento que regula los estudios de estabilidad de las es pecialidades farmacéuticas 
(Draft Regulation governing stability studies for pharmaceutical specialties) (25 pages, in 
Spanish)  
6. Description of content : The purpose of the notified Regulation is to establish:  
- the rules governing stability studies on pharmaceutical specialties ; and 
- the information to be included in the document required for the evaluation of stability 
studies when registering or re -registering pharmaceutical specialties or when making 
changes to the pharmaceutical specialties sanitar y register.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health.  
8. Relevant documents:  
1. 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)  
2. Decreto Supremo N° 016 -2011-SA, Reglamento para el Registro, Control y 
Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios  (Supreme Decre e No. 016-2011-SA, Regulations on the registration, 
control and sanitary surveillance of pharmaceutical products, medical devices and 
sanitary products)  G/TBT/N/PER/94  
- 2 - 
  9. Proposed date of adoption : 18 months after publication in the Official Journal El 
Peruano.  
Proposed  date of entry into force : 18 months after publication in the Official Journal El 
Peruano.  
10. Final date for comments : 16 August 2 017 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addres ses, if available, of other body:  
http://extranet.comunidadandina.org/sirt/public/index.aspx  
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. 1223 and 1239  
Email: otc@mincetur.gob.pe  
https://members.wto.org/crnattachments/2017/TBT/PER/17_2239_00 _s.pdf