G/TBT/N/PER/118  
5 December  2019 
(19-8377) 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 , MINCETUR (Ministry of Foreign Trade and 
Tourism)  
Calle Uno Oeste Nº 50 - Urb. Córpac - Lima 27 - Peru 
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) : 
Pharmaceutical products ; Fish, fresh or chilled, excluding fish fillets and other fish meat 
of heading 03.04 (HS 0302) ; Glands and other organs for organo -therapeutic uses, dried, 
whether or not powdered ; extracts o f glands or other organs or of their secretions for 
organo -therapeutic uses ; heparin and its salts ; other human or animal substances 
prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 
3001) ; Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of 
two or more constituents which have been mixed together for therapeutic or prophylactic 
uses, not put up in measured doses or in forms or packings for retail sale (HS 3003) ; 
Medicaments (excluding goods of he ading 30.02, 30.05 or 30.06) consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses 
(including those in the form of transdermal administration systems) or in forms or 
packings for retail sale (HS 3004) ; Wadding, gauze, bandages and similar articles (for 
example, dressings, adhesive plasters, poultices), impregnated or coated with 
pharmaceutical substances or put up in forms or packings for retail sale for medical, 
surgical, dental or veterinary purposes (HS 30 05); Pharmaceutical goods specified in Note 
4 to this Chapter (HS 3006)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Reglamento que Regula los Cambios de Importancia Mayor de los Productos 
Farmacéuticos con Registro Sanitario (Draft Regulations governing major changes to 
pharmaceutical products in the sanitary register) (22 pages, in Spanish)  
6. Description o f content : The notified draft Regulation s provide for major changes in the 
sanitary register, as they may have repercussions on the quality, safety and effectiveness 
of pharmaceutical products, and establish the conditions and documents required for such 
changes.  G/TBT/N/PER/118  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems 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  
10. Final date for comments : 17 December 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)  
Calle Uno Oeste Nº 50 - Urb. Córpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100, Ext. 1223 and 1239  
Email: otc@mincetur.gob.pe  
http://extranet.comunidadandina.org/sirt/public/index.aspx  
http://consultasenlinea.mincetur.gob.pe/notificaciones/Publico/FrmBuscador.aspx  
http://www.digemid.minsa.gob.pe/Print_Contenido.asp?S eccion=475&Idioma=  
https://members.wto.org/crnattachments/2019/TBT/PER/19_6942_00_s.pdf