Type of Notification
regular notification
Date of Distribution
2018.08.01
WTO Country
Agency Responsible
Ministerio de Salud (Ministry of Health)
Regions Affected
Ministerio de Comercio Exterior y Turismo (Ministry of Foreign Trade and Tourism)
Notified Document Details
Proyecto de Reglamento que regula la presentación y contenido de los documentos requeridos en la inscripción y reinscripción de productos biológicos: vacuna (Draft Regulation on the presentation and content of the documents required for the registration and re-registration of biological products: vaccines) (17 pages, in Spanish)
Product
ICS Code
Covered Products
Pharmaceutical products: Biological products Classified under Chapter 30 of the Harmonized System or Customs Tariff: 3002.20 - Vaccines for human medicine: 3002.20.10.00 - Poliomyelitis vaccines 3002.20.20.00 - Rabies vaccines 3002.20.30.00 - Measles vaccines 3002.20.90.00 - Other
Description of Content

The purpose of the notified Regulation is to establish:
· The regulations governing the presentation of the documents required for the registration and re-registration of biological products: vaccines.
· The information to be included in the documents required for the registration and re-registration of biological products: vaccines.

Objectives & Rationale
Protection of human health
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)

Final Date of Comments
2018.10.28
Contact Details
http://extranet.comunidadandina.org/sirt/public/index.aspx http://www.mincetur.gob.pe/reglamentostecnicos http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2018/RM_623-2018.pdf Ministerio de Comercio Exterior y Turismo - MINCETUR (Ministry of Foreign Trade and Tourism) Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Perú Tel.: (+51-1) 513-6100, Ext. 1223 and 1239 Email: otc@mincetur.gob.pe https://members.wto.org/crnattachments/2018/TBT/PER/18_4115_00_s.pdf
Document Online Link (EN)
Notified Under
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