Exceptional Cannabis Product Import
The Regulation for Registry, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products stipulates import exceptions for products without sanitary/health registry. One of these exceptions is for individual treatment and prevention.
The General Medicine, Supplies and Drug Administration (DIGEMID) authorizes pharmaceutical product import and use upon submitting duly medical proof issued by a prescriber physician and product/device characteristics report.
It should be mentioned that Cannabis psychoactive products are narcotic drugs and should be taken under special prescription. In this sense, DIGEMID press announcement specifies what controlled substances are able to be imported by this procedure and are included in List IIA: Cannabis resins and essential oils, as well as Tetrahydrocannabinols, isomers and stereochemical variants.
Click here to read the statement.
Click here to read Annex N ° 1.
Requirements for exceptional import request for individual treatment are:
1. Request as a matter of Affidavit
Requesting party’s details corresponds to the patient’s details or the person being authorized to complete formalities due to patient’s inability. In this case:
In case of minor or disabled patients, formalities must be completed by their parents or guardian by attaching the pertinent relationship proof to the request.
Click here to see the Request.
Request – Affidavit for exceptional pharmaceutical product import authorization
2. Medical Proof
By complying with this requirement, the corresponding prescription that must be clear, legible and read the pertinent diagnosis has to be submitted.
Click here to see the form.
Below the step-by-step process is detailed from prescription to obtaining the exceptional Cannabis pharmaceutical product import authorization.
For further details, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and/or Cecilia Alarcón (calarcon@estudiorodrigo.com).
