Zimbabwe medicinal cannabis licences due for renewal

Medicinal cannabis producers in Zimbabwe have been warned to urgently renew their operating licences as permits issued in 2021 approach the end of their five-year validity period.

The Medicines Control Authority of Zimbabwe (MCAZ) has confirmed that all licences granted under the first round of approvals following the legalisation of medicinal and scientific cannabis production will expire this year, stressing that late renewal applications will not be accepted.

In a formal notice to licence holders, MCAZ said producers involved in the cultivation of cannabis for medicinal and scientific purposes must submit renewal applications before their licences lapse to avoid disruptions to their operations.

MCAZ Director General Mr Richard Rukwata said the authority was issuing early notice to allow licence holders adequate time to comply with renewal requirements.

"Licences issued in 2021 were valid for five years and are now reaching expiry. Renewal is mandatory for continued lawful operations," Rukwata said.

He warned that failure to act within the prescribed timeframe would result in the automatic loss of licensing status, as the authority is not legally permitted to process renewal applications once a licence has expired.

The renewal process is governed by the Dangerous Drugs Regulations contained in Statutory Instrument 62 of 2018. Under the regulations, licence holders must lodge renewal applications before expiry and demonstrate continued compliance with all conditions attached to the original licence.

Applicants are required to submit the prescribed renewal fee, a copy of the existing licence, and a declaration signed by an authorised person confirming that all licensing information remains accurate and complete. The declaration must also confirm ongoing compliance with regulatory requirements relating to production standards, security, record keeping and operational oversight.

MCAZ said any changes that have occurred since the original licence was issued — including ownership or directorship changes — must be fully disclosed. In such cases, applicants are required to submit updated company records, certified identification documents for new directors, and security clearance documentation, including fingerprints processed by the Zimbabwe Republic Police. Proof of compliance with conditions imposed by the Minister of Health at the time of licensing is also mandatory.

The authority clarified that once a renewal application has been properly lodged before the expiry date, the licence remains valid until a decision is communicated by the Minister of Health. This provision is intended to protect compliant producers from operational interruptions caused by administrative delays.

As part of the renewal process, MCAZ has issued a proforma invoice setting the cannabis licence renewal fee at US$20 000. The authority said its cash office is operational and able to accept payments, while bank deposits can also be made through a designated Nedbank account in Harare.

However, licence holders have been cautioned that bank transfers may attract charges that could result in underpayment, and they are advised to ensure any shortfalls are covered to allow full settlement of fees. Proof of payment must be submitted promptly, clearly referencing the invoice number or purpose of payment, to avoid delays in processing.

Zimbabwe legalised the production of cannabis for medicinal and scientific use as part of efforts to diversify agricultural exports and attract investment into pharmaceutical research and manufacturing. Several companies have since entered the sector, positioning the country as a potential regional supplier of medicinal cannabis products.

With the first cohort of licences now expiring, authorities say the renewal process will be a key test of regulatory compliance and sector maturity, reiterating that strict adherence to timelines and conditions remains central to maintaining the integrity of Zimbabwe's medicinal cannabis industry.