G/TBT/N/PER/104  
7 June 2018 
(18-3493) 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 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, 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 provided in addition, where applicable) : 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)  
5. Title, number of pages and language(s) of the notified document : 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 th erapeutic use of cannabis and its derivatives) (20 pages, in Spanish)  
6. 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 d elivery of research, production, import and marketing 
licences that enable access to medicinal cannabis and its derivatives.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health  
8. 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-G/TBT/N/PER/104  
- 2 - 
  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)  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : 180 calendar days after publication in the Official 
Journal El Peruano  
10. Final date for comments : 30 August 2 018 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
http://extranet.comunidadandina.org/sirt/public/index.aspx  
 
http://www.mincetur.gob.pe/reglamentostecnicoshttp://www.digemid.minsa.gob.p e/UpLoa
d/UpLoaded/PDF/Publicaciones/DocumentosConsulta/P08_435 -2018-16-05.pdf  
 
Ministerio de Comercio Exterior y Turismo  - MINCETU R (Ministry of Foreign Trade and 
Tourism)  
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Perú 
Tel.: (+51-1) 513 -6100, Ext. 12 23 and 1239  
Email: otc@mincetur.gob.pe  
 
https://members.wto.org/crnattachments/2018/TBT/PER/18_2843_00_s.pdf