G/TBT/N/PER/64
19 November 2014
(14-6763)  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 provid ed in addition, where applicable):  
- Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, 
and biological and galenic products. - Medical devices 
These products are 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 
Directiva Sanitaria que regula las condiciones para la presentación de los resultados de control de calidad del primer lote y subsiguientes lotes de los productos farmacéuticos y 
dispositivos médicos  (Draft Health Directive laying down requirements for the submission 
of quality control results for the first and subsequent batches of pharmaceutical products and medical devices) (7 pages, in Spanish) 
6. Description of content: The draft Health Directive contains nine titles and two annexes, 
and establishes quality control verification and phasing-in requirements for the first and 
subsequent batches of pharmaceutical products and medical devices prior to marketing or 
distribution in the Peruvian market. 
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/64 
- 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: 9 February 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 Exterior y Turismo - MINCETUR 
Calle Uno Oeste No. 50 - Urb. Corpac 
Lima 27 
Peru 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/ 
http://members.wto.org/crnattachments/2014/tbt/PER/14_5067_00_s.pdf