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 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 and e-mail 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 [ ], 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, sanitary 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 sighttesting 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, examination or treatment tables, chairs and the like
(HS 9022); medical, surgical, dental or veterinary 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
-2movements; 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 hygiene 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 language(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 transitional supplementary provisions and one
repealing supplementary provision which amend the regulations on the registration,
control and sanitary surveillance of pharmaceutical products, medical devices and
sanitary products, approved by Supreme 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.
10.
Proposed date of adoption:
The day following publication in the
Official Journal El Peruano.
Proposed date of entry into force:
The day following publication in the
Official Journal El Peruano.
Final date for comments: Not applicable.
G/TBT/N/PER/54
-3-
11.
Texts available from: National enquiry point [X], or address, telephone and fax
numbers and e-mail and website addresses, 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.pe/reglamentostecnicos
http://www.digemid.minsa.gob.pe/