G/TBT/N/PER/144  
17 August  2022 
(22-6257) 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 , MINSA (Ministry of Health)  
Av. Salaverry 801  
Jesús María - Lima, Lima, Peru  
Tel.: (+51-1) 315 -6600 
Email: webmaster@minsa.gob.pe  
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 de Comercio Exterior y Turismo , MINCETUR (Ministry of Foreign Trade and 
Tourism)  
Calle U no Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100, Ext. 1223 or 1239  
Email: otc@mincetur.gob.pe  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
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 language(s) of the notified document : Proyecto de 
Decreto Supremo que aprueba el Reglamento que regula la presentación y contenido de 
los documentos requeridos en la inscripción y reinscripción de productos biológicos : Otros 
productos biológicos  (Draft Supreme Decree approving the presentation and content of 
the documents required for the registration and re -registration of biological products : 
other biological products) (27 pages, in Spanish)  
6. Description of content : The purpo se of the notified text is to establish:  
 The regulations governing the presentation of the documents required for the registration 
and re -registration of biological products : other biological products.  
 The information to be included in the documents requ ired for the registration and re -
registration of biological products : other biological products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  G/TBT/N/PER/144  
- 2 - 
  8. Relevant documents:  
1. Law No. 29459,  Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios . 
2. Supreme Decree No. 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 after publication in the Official Journal, 
El Peruano.  
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] 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. Corpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100, Ext. 1223 or 1239  
Email: otc@mincetur.gob.pe  
Ministerio de Salud (MINSA)  
Av. Salaverry 801  
Jesús María - Lima, Lima, Peru  
Tel.: (+51-1) 315 -6600 
Email: webmaster@minsa.gob.pe  
https://www.gob.pe/institucion/minsa/normas -legales/2104585 -1019-2021-minsa  
http://extranet.comunidadandina.org/sirt/public/buscapalavra.aspx  
http://consultasenlinea.mincetur.gob.pe/notificaciones/Publico/FrmBuscador.aspx  
https://members.wto.org/crnattachments/2022/TBT/PER/22_5637_00_s.pdf  
https://members.wto.org/crnattachments/2022/TBT/PER/22_5637_01_s.pdf