G/TBT/N/PER/105  
1 August  2018 
(18-4870) 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 de Comercio Exterior y Turismo (Ministry of Foreign Trade and Tourism)  
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 : Biological products  
Classified under Chapter 30 of the Harmonized System or Customs Tariff:  
3002.20  - Vaccines for hu man medicine:  
3002.20.10.00  - Poliomyelitis vaccines  
3002.20.20.00  - Rabies vaccines  
3002.20.30.00  - Measles vaccines  
3002.20.90.00  - Other  
 
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Reglamento que regula la presentación y contenido de los documentos requeridos en la 
inscripción y reinscripción de productos biológicos : vacuna  (Draft Regulation on the 
presentation and content of the documents required for the registration and re -registration 
of biological produ cts: vaccines) (17 pages, in Spanish)  
6. Description of content : The purpose of the notified Regulation is to establish:  
 The regulations governing the presentation of the documents required for the 
registration and re -registration of biological products : vaccines.  
 The information to be included in the documents required for the registration and 
re-registration of biological products : vaccines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health  G/TBT/N/PER/105  
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  8. Relevant documents:  
1. Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y 
Productos Sanitarios  (Law No. 29459, Law on pharmaceutical products, medical 
devices and sanitary products)  
2. Decreto Supremo N° 016 -2011/SA, Reglamento  para el Registro, Control y 
Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios  (Supreme Decree No. 016-2011/SA, Regulations on the registration, 
control and sanitary surveillance of pharmaceutical products, medica l devices and 
sanitary products)  
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 : 28 October 2 018 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
http://extranet.comunidadandina.org/sirt/pu blic/index.aspx  
http://www.mincetur.gob.pe/reglamentostecnicos  
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2018/RM_623 -
2018.pdf  
Ministerio de 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  
https://members.wto.org/crnattachments/2018/TBT/PER/18_4115_00_s.pdf