G/TBT/N/PER/85  
2 May 2016  
(16-2448)  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, 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 información mínima del documento que debe contener la validación de técnicas analíticas propias  (Draft Regulation on the minimum information to 
be contained by the document required for the validation of analytical techniques specific 
to the manufacturer) (7 pages, in Spanish)  
6. Description of content: The notified draft Regulation establishes the minimum 
information to be contained by the document required for the assessment of the validation of analytical techniques specific to th e manufacturer, which are necessary for the 
registration and re-registration of and changes regarding pharmaceutical products in the 
sanitary register. 
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/85 
- 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: 27 July 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. 1239 
Email: otc@mincetur.gob.pe  
http://extranet.comunidadandina.org/sirt/public/index.aspx 
http://www.mincetur.gob.p e/reglamentostecnicos 
http://www.digemid. minsa.gob.pe/ 
https://members.wto.org/crnattachments/2016/TBT/PER/16_1738_00_s.pdf