G/TBT/N/PER/ 92 
 
8 May 2017  
(17-2460) Page: 1/2 
Committee on Technical Barriers to Trade  Origina l:  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 Hea lth) 
Name and address (including telephone and fax numbers and 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 Ext erior y Turismo , MINCETUR (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 prov ided 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 la expedición del cer tificado de liberación de lote de productos 
biológicos: vacunas o derivados de plasma humano  (Draft Regulation on  the issue of 
batch release certificates for  biological products  (vaccines or human plasma derivatives )) 
(6 pages, in Spanish).   
6. Descriptio n of content:   
The aims of the notified draft Regulation are to : 
 establish  the rules governing the issue of  batch release certificates for  biological 
products  (vaccines or human plasma derivatives ) issued by the  National Authority for  
Pharmaceutical Produc ts, Medical Devices and Sanitary Products ;  
 establish the information to be included in the documents required for the issue of 
batch release certificates for  biological products  (vaccines or human plasma 
derivatives ).  
7. Objective and rationale, includi ng 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, medic al 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 re gistration, control and sanitary 
surveillance of pharmaceutical products, medical devices and sanitary products).  G/TBT/N/PER/ 92 
 
- 2 - 
 
  9. Proposed date of adoption: 180 calendar days after publication in the Official Journal 
El Peruano  
Proposed date of entry into force: 180 c alendar days after publication in the Official 
Journal El Peruano  
10. Final date for comments:  2 August 2017   
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers and email and website addresses, if available, of oth er body:   
Ministerio de Comercio Exter ior y Turismo,  MINCETUR  
Calle Uno Oeste Nº 50, Urb. Corpac, Lima 27,  Perú 
Tel.: (+51-1) 513 -6100, Ext,  1223 o r 1239 
E-mail: otc@mincetur.gob.pe  
Website:  
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/2017/TBT/PER/17_2182_00_s.pdf