G/TBT/N/PER/70  
15 April 2015  
(15-2012)  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 governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible: Ministerio de Salud  (Ministry of Health) 
Name and address (including telephon e 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: similar biological products, classified under Chapter 30 of the 
Harmonized System or Customs Tariff. 
5. Title, number of pages and lang uage(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 similares  (Draft Regulation on the 
presentation and content of the documents requ ired for the registration and re-registration 
of similar biological products) (21 pages, in Spanish) 
6. Description of content: The draft Regulation contains two titles, nine articles, five 
transitional supplementary provisions and three annexes, and establishes: 
1. The regulations governing the presenta tion of the documents required for the 
registration and re-registration of similar biological products; 
2. The information to be included in the documents required for the registration and re-
registration of similar biological products. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health. 
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, medical devices and sanitary 
products). G/TBT/N/PER/70 
- 2 - 
  9. Proposed date of adoption: 180 calendar days after publication in the Official Journal 
El Peruano . 
Proposed date of entry into force: 180 calendar days after publication in the Official 
Journal El Peruano . 
10. Final date for comments: 8 July 2015 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Ministerio de Comercio Exte rior y Turismo – MINCETUR 
Calle Uno Oeste Nº 50 – Urb. Corpac 
Lima 27 – Perú 
Tel.: +(51-1) 513-6100, Ext. 8022 Fax: +(51-1) 513-6100, Ext. 8002 
Email: otc@mincetur.gob.pe  
http://extranet.comunidadandina.org/sirt/public/index.aspx  
http://www.mincetur.gob.p e/reglamentostecnicos  
http://www.digemid. minsa.gob.pe/ 
https://members.wto.org/crnattachments/2015/TBT/PER/15_1575_00_s.pdf