G/TBT/N/PER/128  
14 January  2021 
(21-0468) 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 11, -Perú 
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 and 1239  
Email: otc@mincetur.gob.pe  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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 Harmonized System or 
Customs Tariff  
5. Title, number o f pages and language(s) of the notified document : Reglamento 
para el Registro Sanitario Condicional de Medicamentos y Productos Biológicos 
(Regulation for the conditional sanitary registration of medicines and biological products) 
(17 pages, in Spanish)  
6. Description of content : 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, 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  
8. Relevant documents:  
1. Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y 
Productos Sanitarios ; 
2. Ley N° 31091, Ley que garantiza el acceso al tratamiento preventivo y curativo 
de la enfermedad por coronavirus SARS -CoV-2 y de otras enfermedades que G/TBT/N/PER/128  
- 2 - 
  dan origen a emer gencias sanitarias nacionales y otras pandemias declaradas 
por la Organización Mundial de la Salud ; 
3. Decreto Supremo N° 002 -2021-SA que aprueba el Reglamento para el Registro 
Sanitario Condicional de Medicamentos y Productos Biológicos . 
9. Proposed date of adoption : The day following publication in the Official Journal El 
Peruano . 
Proposed date of entry into force : The day following publication in the Official Journal 
El Peruano . 
10. Final date for comments : Not applicable.  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2021/DS_PER
UANO_002 -2021-SA.pdf  
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_0438_00_s.pdf