Medicinal Product Support in Zimbabwe
End-to-end Regulatory support from experienced Africa-focused Regulatory experts.

Medicinal Products Regulatory Support in Zimbabwe – Overview

Zimbabwe is a key pharmaceutical market in Southern Africa, with consistent demand for generic medicines, essential drugs, vaccines, anti-infectives, chronic disease treatments, and public health products. The country’s Regulatory framework is aligned with WHO guidelines and SADC Medicines Regulatory Harmonization (MRH) initiatives, making Zimbabwe drug registration a strategic step for companies expanding across Africa.

The Medicines Control Authority of Zimbabwe (MCAZ) oversees pharmaceutical product approvals, requiring:

• A locally registered MAH in Zimbabwe
• CTD-format dossier submission
• GMP-certified manufacturing sites
• Product samples, labeling, and pharmacovigilance compliance

Freyr Solutions supports pharmaceutical, biotech, and generics manufacturers with Zimbabwe Regulatory submissions, lifecycle management, renewals, and post-approval compliance, ensuring efficient and compliant pharmaceutical market entry in Zimbabwe.

Medicinal Product Classification in Zimbabwe

Zimbabwe classifies human medicinal products for distribution under the MCAZ (Medicines Control Authority of Zimbabwe). These classifications dictate dispensing rules, with P.P. requiring a doctor's prescription and P.I.M. requiring a pharmacist's recommendation, while H.R. allows self-medication. 

Here's a breakdown of the main categories:

1. Special Restricted Preparations (S.R.):

• These are highly controlled medicines, such as strong narcotics or potent psychotropic substances.
• Supply and handling are subject to strict Regulatory controls and special authorization.

2. Prescription Preparations (P.P.):

• These medicines require a prescription from a licensed medical practitioner for dispensing.
• Their supply is strictly controlled through pharmacies.

3. Prescription Preparations (P.P. 10):

• A sub-category of prescription medicines, subject to additional restrictions (example: may require a prescription in duplicate or specific reporting).

4. Pharmacist-Initiated Medicines (P.I.M.):

• Can only be supplied after assessment and recommendation by a pharmacist.
• Record-keeping of these transactions is required, but no doctor’s prescription is necessary.

5. Pharmacy Medicines (P.):

• Non-prescription medicines that can be supplied by a registered pharmacist or a licensed pharmacy without a doctor’s prescription.

6. Household Remedies (H.R.):

• Available for general sale without restriction.
• Considered safe for unsupervised use by the general public.

Medicinal Product Registration & Approval in Zimbabwe

The Medicines Control Authority of Zimbabwe (MCAZ) regulates drug registration, importation, and marketing authorization to ensure that only safe, effective, and quality-assured medicines are available in Zimbabwe.

Key Steps in Drug Registration in Zimbabwe

1. Product Classification & Regulatory Pathway Assessment
Initial classification determines whether the product qualifies as a medicine, supplement, herbal product, or medical device, and defines the Zimbabwe Regulatory submission requirements.

2. Local MAH & Importer Licensing
The Marketing Authorization Holder (MAH) must be locally registered in Zimbabwe and licensed by MCAZ. Importation and distribution must occur through an MCAZ-approved wholesaler or importer.

3. CTD Dossier Submission
Applicants submit a CTD dossier including:

• Quality, safety, and efficacy data
• GMP certificate of the manufacturer
• Certificate of Pharmaceutical Product (CPP)
• Finished product specifications and samples
• Zimbabwe-compliant labeling and package inserts

4. Technical Review & Laboratory Testing
MCAZ conducts a scientific evaluation and quality testing. Deficiency letters may be issued for additional clarification.

5. Grant of Marketing Authorization
Upon approval, MCAZ issues a Zimbabwe product registration certificate, authorizing importation, sale, and distribution.

6. Validity, Renewals & Variations

• Registration validity: 5 years
• Renewals required before expiry
• Post-approval changes require MCAZ-approved variations

7. Post-Approval Regulatory Compliance
Includes pharmacovigilance reporting, GMP compliance, labeling control, and Regulatory audits.