G/TBT/N/PER/69  
15 April 2015  
(15-2011)  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: biological products: biotech 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 Decreto Supremo que modifica el artículo 103 del Reglamento para el 
Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos 
Médicos y Productos Sanitarios  (Draft Supreme Decree amending Article 103 of the 
regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products); 
 Proyecto de Reglamento que regula la presentación y contenido de los documentos 
requeridos en la inscripción y reinscripción de productos biológicos: productos biotecnológicos  (Draft Regulation on the presentation and content of the documents 
required for the registration and re-registration of biological products: biotech 
products) (16 pages, in Spanish) 
6. Description of content:  
 The draft Supreme Decree contains 4 articles. 
 The draft Regulation contains two titles, eight articles, three transitional 
supplementary provisions and three annexes, and establishes: 
(a) The regulations governing the presentation of the documents required for the  
registration and re-registration of biological products: biotech products; 
(b) The information to be included in the documents required for the registration and 
re-registration of biological products: biotech products. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health. G/TBT/N/PER/69 
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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, medical devices and sanitary products). 
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 [X] 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_1574_00_s.pdf