G/TBT/N/PER/96  
30 June 2017 
(17-3533) 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:   
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 H armonized System or 
Customs Tariff.  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Reglamento que regula las condiciones para la presentación de los resultados de control de 
calidad del primer lote y subsiguientes lotes de  productos farmacéuticos (Draft Regulation 
laying down requirements for the submission of quality control results for the first and 
subsequent batches of pharmaceutical products) (8 pages, in Spanish)  
6. Description of content : The purpose of the notifie d Regulation is to establish the 
requirements for the quality control of the first and subsequent batches of pharmaceutical 
products, and the requirements for the submission of the results of such quality control, 
prior to marketing or distribution on the Peruvian market.  
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)  
9. Proposed date of adoption : 180 days after publication in the Official Journal El Peruano.  
Proposed date of entry into force : 180 days after publication in the Official Journal El 
Peruano.  G/TBT/N/PER/96  
- 2 - 
  10. Final date for comments : 25 September 2 017 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website  addresses, 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  
 
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