G/TBT/N/PER/114  
29 August 2019  
(19-5564) 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 Health)  
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 d e Comercio Exterior y Turismo , MINCETU R (Ministry of Foreign Trade and 
Tourism)  
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Perú 
Tel.: (+51-1) 513 -6100, Ext. 1223 and 1239  
Email: otc@mincetur.gob.pe  
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) : Articles 
for babies ; Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006)  
5. Title, number of pages and language(s) of the noti fied document : Proyecto de 
Reglamento para el Registro Sanitario de Productos Sanitarios : Artículos para Bebés  
(Draft regulation on sanitary registration of sanitary products : Articles for babies). 
(10 pages, in Spanish)  
6. Description of content : The purpose of the notified regulation is to set forth the 
regulatory provisions for Law No. 29459, Law on pharmaceutical products, medical 
devices and sanitary products : Articles for babies.  
7. Objective and rationale, including the nature of urgent probl ems where 
applicable : Protection of human health or safety  
8. Relevant documents:  
1. Ley N°  29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y 
Productos Sanitarios  
2. Decreto Supremo N° 016 -2011/SA, Reglamento para el Registro, Control y 
Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : Six months following publication in the Official 
Journal El Peruano  G/TBT/N/PER/114  
- 2 - 
  10. Final date for comments : 27 October 2 019 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Comercio Exterior y Turismo , MINCETUR (Ministry of Foreign Trade and 
Tourism)  
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Perú 
Tel.: (+51-1) 513-6100, Ext. 1223 and 1239  
Email: otc@mincetur.gob.pe  
Ministerio de Salud  (Ministry of Health)  
Dirección General de Medicamentos, Insumos y Drogas , DIGEMID (Directorate -General 
of Drugs and Medicinal Products)  
Av. Parque de las Leyendas 240 Torre B - San Miguel  
Tel.: (+51-1) 631 -4300 
http://www.digemid.minsa.gob.pe/  
http://www.mincetur.gob.pe/reglamentostecnicos  
http://extranet.comunidadandina.org/sirt/public/index.aspx  
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Publicaciones/DocumentosCo
nsulta/P08_435 -2018-16-05.pdf  
https://members.wto.org/crnattachments/2019/TBT/PER/19_4771_00_s.pdf