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Medical Cannabis Newsletter – May 2019

CANNABIS NEWSLETTER

CANNABIS: REGULATION PROGRESS IN PERU

1. Registry of Cannabis Patients

The General Medicine, Supplies and Drug Administration (DIGEMID) implemented the National Registry of Medical and Therapeutic Cannabis Patients.

(http://digemid_regiones.minsa.gob.pe/ControlCannabis/registroDeclaracionJurada.jsp)

Up to date, 488 patients are registered according to the search on “Acceso a la Información Pública” (Access to Public Information) of DIGEMID via SAIP VIA WEB No. 19-004047.

2. Registry of Cannabis Pharmacies/Drug Stores

Forms A-2 and A-LPF corresponding to Health Authorization for Operating for pharmacies/drug stores and laboratories are updated by DIGEMID detailing the activities of medical Cannabis byproducts:

  • Herbal Medicine
  • Pharmaceutical Specialty
  • Health Natural Product

Form A-2: Pharmacies/Drug Stores

Form A-LPF: Laboratories

(http://www.digemid.minsa.gob.pe/Main.asp?Seccion=624)

3. DIGEMID Alert for Cannabis with No Health/Sanitary Registry

DIGEMID published a statement on complaints about illegal trade of allegedly manufactured Cannabis-based products whose labeling shows a fake health/sanitary registry (http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2019/C21_2019-05-22.pdf). Up to date, no company has filed in DIGEMID any application form for health/sanitary registry for medical Cannabis-based products. Illegal trade complaints may be filed in the webpage: http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/denuncias.pdf.

4. Peruvian Health Institute (INS) – Educational Information about Cannabis

Information related to Cannabis scientific research permit has been uploaded on the INS webpage. This information provides the definition of Cannabis scientific research permit, the pertinent authority issuing such permit, and the requirements for health scientific research permit.

(https://web.ins.gob.pe/es/investigacion-en-salud/registro-investigacion-cannabis)

5. Registry of Authorized Cannabis Research Institutions

The registry sample of the Authorized Cannabis and Byproducts Research Institutions is displayed on the INS webpage.

6. Scientific Research Registry

The Form of registry of scientific research not involving human has been implemented by INS. The registration is made online under this link: https://web.ins.gob.pe/es/investigacion-en-salud/registro-investigacion-cannabis. The following information shall be available thereon: details of the research institution and the research ethics committee; uploaded copies of the permits of the institution where research will be carried out; approval of the research protocol by the Committee on Ethics; authorization of the production laboratory; security protocol approved by Ministry of Internal Affairs (MININTER).

7. Directive of Security Protocol to be approved

The Ministry of Internal Affairs, through the Peruvian Police Force Anti-Drug Division (DIRANDRO), will draft the technical guidelines according to the conditions and criteria to approve the security protocols. In this sense, it is still pending to be approved by MININTER.

8. Phytosanitary Requirements Pending to Be Published

The National Service for Agricultural Health (SENASA) opened to public consultation the “Phytosanitary requirements of mandatory compliance for Cannabis (Cannabis sativa) seed import of Colombian origin”[1]. Said public consultation ended last April 20. Not yet published.

9. Terms and Due Dates

The Supreme Executive Order No. 005-2019-SA established a term of 60 and 90 business days to implement several procedures.

For the following procedures, the term of 60 business days was due on May 22:

For the following procedures, the term of 90 days will be due on July 3:

For further details, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and/or Cecilia Alarcón (calarcon@estudiorodrigo.com).

[1] https://www.senasa.gob.pe/senasa/consulta-publica/