G/TBT/N/PER/54  
 
13 January 2014  
(14-0101)  Page: 1/3  
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 telephone and fax numbers and e-mail and 
website addresses, if availa ble) of agency or author ity 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 [ ], 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 (HS 30); perfumes and toilet waters (HS 3303); beauty or make-up preparations and preparations for the care of the skin (other than 
medicaments), including sunscreen or suntan preparations; manicure or pedicure 
preparations (HS 3304); preparations for use on the hair (HS 3305); soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, 
moulded pieces or shapes, whether or not containing soap; organic surface-active 
products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, 
impregnated, coated or covered with soap or detergent (HS 3401); organic surface-active 
agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01 (HS 3402); -- of a kind used in the textile or like 
industries (HS 380991); toilet paper and similar paper, cellulose wadding or webs of 
cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width not exceeding 36 cm, or cut to size or shape; handkerchiefs, cleansing tissues, towels, 
tablecloths, serviettes, napkins and napkin liners for babies, sanitary towels (pads) and 
tampons, bed sheets and similar household, sa nitary or hospital articles, articles of 
apparel and clothing accessories (HS 4818); wadding of textile materials and articles 
thereof; textile fibres, not exceeding 5 mm in length (flock), textile dust and mill neps 
(HS 5601); instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus,  other electro-medical apparatus and sight-
testing instruments (HS 9018); mechano-therapy appliances; massage apparatus; 
psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol 
therapy, artificial respiration or other therapeutic respiration apparatus (HS 9019); orthopaedic appliances, including crutches, surgical belts and trusses; splints and other 
fracture appliances; artificial parts of the body; hearing aids and other appliances which 
are worn or carried, or implanted in the body, to compensate for a defect or disability (HS 9021); apparatus based on the use of X-rays or of alpha, beta or gamma radiations, 
whether or not for medical, surgical, dental or veterinary uses, including radiography or 
radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examinatio n or treatment tables, chairs and the like 
(HS 9022); medical, surgical, dental or vete rinary furniture (for example, operating 
tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); 
barbers' chairs and similar chairs, having rotating as well as both reclining and elevating G/TBT/N/PER/54 
 
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  movements; parts of the foregoing articles (HS 9402). 
Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, 
and biological and galenic products classified under Chapter 30 of the Harmonized System 
or Customs Tariff. 
Medical devices classified under headings 9018, 9019, 9021, 9022 and 9402 of the 
Harmonized System or Customs Tariff. 
Sanitary products: cosmetics, domestic hygi ene products and absorbent personal hygiene 
products classified under the following headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 
3809.91.00, 4818 and 5601.  
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Decreto Supremo que Modifica Artículos del Reglamento para el Registro, Control y 
Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios  (Draft Supreme Decree amending certain articles of the regulations on the 
registration, control and sanitary surveillance of pharmaceutical products, medical devices 
and sanitary products) (9 pages, in Spanish)  
6. Description of content: The notified draft Supreme Decree contains three articles, three 
final supplementary provisions, four transi tional supplementary provisions and one 
repealing supplementary provision which am end the regulations on the registration, 
control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, approved by Suprem e Decree No. 016-2011-SA and amended by 
Supreme Decree No. 001-2012-SA, with a view to making the implementation of the 
regulations and Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products) more viable. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health. 
8. Relevant documents:  
1. Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary 
products). 
2. Supreme Decree No. 016-2011-SA approving the regulations on the registration, 
control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, amended by Supreme Decree No. 001-2012-SA. 
3. Publication in which proposal will appear following adoption.  
9. Proposed date of adoption: 
 
Proposed date of entry into force:   The day following publication in the 
Official Journal El Peruano . 
The day following publication in the 
Official Journal El Peruano . 
10. Final date for comments: Not applicable. G/TBT/N/PER/54 
 
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  11. Texts available from: National enquiry point [X], or address, telephone and fax 
numbers and e-mail 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 - Perú 
Tel.: (+51-1) 513-6100, Ext. 8040 Fax: (+51-1) 513-6100, Ext. 8002 
E-mail: otc@mincetur.gob.pe 
Also available online at: 
http://members.wto.org/crnattachments/2014/tbt/PER/14_0038_00_s.pdf 
http://www.comunidadandina.org/SIRT 
http://www.mincetur.gob.p e/reglamentostecnicos  
http://www.digemid. minsa.gob.pe/