Legal Situation
Since 2019, INFARMED (Portugal) and ANVISA (Brazil) approved the use of Cannabis for medical purposes.
ELS Solutions has been following these changes and has been active in this market in Brazil, Portugal and worlwide, providing the following services:
- Costumized business plan elaboration;
- Strategic choice of the cultivation field location and facilitation of the relationship with the Municipalities;
- Preparation and submission of licensing files;
- GMP Certification;
- License for seed cultivation / import and export;
- Active management of international distributors and buyers;
- Cannabis-based product registration.
In addition to actively participating in these matters in Portugal, ELS Solutions has also been involved in the discussion of ANVISA regarding the Public Consultations published in Brazil, contributing to Portugal’s regulatory model to initiate the regulation of Cannabis for medicinal purposes in Brazil.
ELS Solutions is the partner of choice in all stages, including but not limited to:
ELS Solutions is the partner of choice in all stages, including but not limited to:
Regulatory configuration and file submission;
ACM and AIM INFARMED authorizations;
EU-GMP certification that includes all necessary steps;
Design, layout, engineering and production planning, including master of work;
Analytical testing;
Batch release;
Pharmaceutical containers;
Compliance with pharmacovigilance;
Audit management and assistance;
Regulatory and administrative authorization at the municipal level.
