Type of Notification
regular notification
Date of Distribution
2018.06.07
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 de la Ley 30681, Ley que regula el uso medicinal y terapéutico, del Cannabis y sus derivados (Draft regulations implementing Law No. 30681, Law regulating the medicinal and therapeutic use of cannabis and its derivatives) (20 pages, in Spanish)
Product
ICS Code
Covered Products
Cannabis seeds, resin, extract, tinctures and oil (tariff headings: 1211.90.90.99, 1301.90.90.90, 1302.19.91.00 and 1302.19.99.00)
Description of Content

The purpose of the notified text is to establish:
· rules to regulate the medicinal and therapeutic use of cannabis and its derivatives,
· requirements for the delivery of research, production, import and marketing licences that enable access to medicinal cannabis and its derivatives.

Objectives & Rationale
Protection of human health
Relevant Documents

1. Ley N° 30681, Ley que Regula el Uso Medicinal y Terapéutico del Cannabis y sus Derivados (Law No. 30681, Law regulating the medicinal and therapeutic use of cannabis and its derivatives)
2. 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)
3. Decreto Ley N° 22095, Ley de Represión del Tráfico Ilícito de Drogas (Decree Law No. 22095, Law on the Repression of Illegal Drug Trafficking)
4. Decreto Supremo N° 023-2001/SA Reglamento de Estupefacientes, psicotrópicos y otras sustancias sujetas a fiscalización Sanitaria (Supreme Decree No. 023-2001/SA, Regulations on narcotics, psychotropics and other substances subject to sanitary control)
5. 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)
6. Decreto Supremo N° 014-2011/SA, Reglamento de Establecimientos Farmacéuticos (Supreme Decree No. 014-2011/SA, Regulations on pharmaceutical establishments)

Final Date of Comments
2018.08.30
Contact Details
http://extranet.comunidadandina.org/sirt/public/index.aspx http://www.mincetur.gob.pe/reglamentostecnicoshttp://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Publicaciones/DocumentosConsulta/P08_435-2018-16-05.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_2843_00_s.pdf
Document Online Link (EN)
Notified Under
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