G/TBT/N/PER/137  
13 September  2021 
(21-6766) 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 [.], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
Pharmaceutical products (HS tariff heading 30)  
5. Title, number of pages and language(s) of the notified document : Proyecto de  
Reglamento para el Registro Sanitario Condicional de Medicamentos y Productos 
Biológicos (Draft Regulation for the conditional sanitary registration of medicines and 
biological products) (27 pages, in Spanish)  
6. Description of conte nt: The notified Regulation establishes the regulatory provisions of 
Article 8 of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary 
products), amended by Law No. 31091, in order to regulate the conditional sanitary 
registration of  medicines and biological products with phase III clinical studies.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  G/TBT/N/PER/137  
- 2 - 
  8. Relevant documents:  
1. Law No. 29459 , Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios . 
2. Law No. 31091 , Ley que garantiza el acceso al tratamiento preventivo y curativo de la 
enfermedad por coronavirus SARS -CoV-2 y de otras enfermedades que dan origen a 
emergencias sanita rias nacionales y otras pandemias declaradas por la Organización 
Mundial de la Salud . 
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/2021/TBT/PER/21_5729_00_s.pdf