New Guidelines from the Ministry of Health of Panama for the Licensing of Manufacturing of Medical Cannabis Derivatives
On June 5, 2023, the National Directorate of Pharmacies and Drugs of the Ministry of Health of Panama (or “MINSA” by its Spanish acronym) published a list of requirements and guidelines for companies interested in being assigned the license to manufacture medical cannabis derivatives in the Republic of Panama.
Interested companies have a period of seventy-five (75) business days from the publication date to submit their applications in a sealed envelope to the Medical Cannabis Committee of the Ministry of Health. The envelopes will remain sealed until September 18, 2023, which is the day the seventy-five (75) business day deadline is met. To facilitate the application process, a series of forms has been established that interested companies must complete and submit. These forms address a variety of topics, from administrative and legal details to production and export plans, investment and technical experience, organizational structure, among other aspects.
The set of required forms includes the following:
Form 1: Presentation letter with various attached documents
Form 2: Affidavit of the Legal Representative of the participant
Form 3: Warning Letter of Falsehood
Form 4: Investment Experience
Form 5: Technical Experience
Form 6: Net Worth of the participant
Form 7: Indebtedness Index
Form 8: Diagram of the organizational structure
Form 9: Model of Nominal Shares Affidavit
Form 10: Declaration on compliance with tax obligations
Form 11: Consortium or Strategic Alliance Agreement
Form 12: Confirmation of requirements list (“Check-List”)
It is important to note that the license to manufacture medical cannabis derivatives will only be granted to those companies that, in addition to meeting the application process requirements, have protocols approved by the Ministry of Public Safety (or “MINSEG” by its Spanish acronym). These protocols must contain measures that ensure that the areas and buildings in which the cannabis plants and the medical cannabis derivative are handled always have appropriate protection levels that guarantee their safety.
Interested companies should take the time to carefully review the forms and ensure that they meet all the requirements before submitting their application. Non-compliance with any of the requirements specified in the forms could result in the denial of the license. If your company is considering applying for a license to manufacture medical cannabis derivatives and needs assistance with the process, or if you simply have questions about the guidelines and forms, do not hesitate to contact us by email at quijano@quijano.com.
