Zimbabwe
MCAZ
- Standard, abridged, ZaZiBoNa, WHO or fast-track review
- Applications through ZIMDIS
- An MCAZ import permit for every shipment
Services / 02
Commercialisation in Zimbabwe & South Africa.
From your dossier to a pharmacy shelf in Zimbabwe or South Africa: registered, GMP-cleared, imported and distributed, without dealing with the regulator yourself.
Who it’s forManufacturers registering and launching a medicine in Zimbabwe or South Africa, and the local agents who work for them.
Two markets
Zimbabwe and South Africa.
South Africa
SAHPRA
- Full, reliance, collaborative or priority review
- eCTD 3.1 through SAHPRA’s Engagement Portal
- A licensed importer; per-shipment permits only for Schedule 5–8
The problem
Why this stalls.
Registering and launching a medicine is unforgiving.
MCAZ refuses a dossier that fails screening twice. SAHPRA gives one response round at screening and three at evaluation.
Files die on procedure too: a wrong payment, a missing sample, a missed query deadline.
And without the right local partners, a registered product still can’t reach a pharmacy shelf.
What’s included
The deliverables.
- 01
Market Entry Check
Free, six questions, five minutes. Your MCAZ or SAHPRA pathway, review time, factory route, advertising rules and the documents to prepare.
Results on screen straight away.
Run the free check - 02
Dossier pack (Module 1)
You have Modules 2 to 5. We build the country part: the MC8 pack for MCAZ, or SAHPRA’s form 1.2.1, PI, PIL and eCTD sequence.
Quoted per product.
Start your dossier pack - 03
Dossier gap review
Your dossier checked against MCAZ’s or SAHPRA’s screening checklist before any fee is paid, with a regulatory reviewer on bioequivalence, stability and active-ingredient data.
A red, amber or green rating per section, a list of fixes and your pathway confirmed.
Get your dossier reviewed - 04
Filing management
We carry your application to the certificate: through ZIMDIS for MCAZ, or the eCTD portal for SAHPRA. Exact payment, submission, samples, screening and every query deadline.
A status page shows where your file is, every letter within 24 hours, and a countdown on each deadline.
Start your filing - 05
GMP clearance
Every factory is cleared before registration. We find the cheapest valid route: MCAZ’s exemption, desk review or inspection, or SAHPRA reliance on a recent PIC/S or WHO approval.
Priced per site: one clearance covers every product from it.
Start your GMP clearance - 06
Partner matching
Local holder, responsible pharmacist, pharmacovigilance provider and licensed importer-wholesaler, shortlisted and signed. Also distributors, marketers, labs, pharmacies and doctors.
We match your needs to vetted local providers and make the introductions.
Find a partner - 07
Import desk
Zimbabwe: an MCAZ permit and verification fee for every shipment. South Africa: a SAHPRA-licensed importer, Schedule 5–8 permits and port release.
Charged per consignment.
Set up your import desk - 08
Distribution setup
Wholesalers checked against the regulator’s licence records and signed on margin, credit and territory; channels planned by schedule; and sales reps set up.
From the importer’s warehouse to pharmacy shelves.
Plan your distribution
How it works
Four steps.
- 01
Check
Run the free Market Entry Check for your market to see your pathway and document list.
- 02
Prepare
We build Module 1 and check the whole dossier against MCAZ or SAHPRA screening.
- 03
File
We carry the application and the GMP clearance through to the certificate.
- 04
Launch
Partners signed, every shipment cleared, and distribution to the shelf.
What you receive
In your hands.
- Your MCAZ or SAHPRA pathway and review time
- The documents to prepare
- A red, amber or green rating per dossier section
- A list of fixes before filing
- Your application filed and tracked to the certificate
- A live status page with every regulator letter
- Your factory cleared for GMP, with renewals tracked
- Every consignment permitted and released
- Wholesalers signed and sales reps set up
- A vetted shortlist of local partners
- Introductions through to a signed agreement
Engagement model
Start free. Pay only for what you use.
Dossier gap review
Quoted on the size of your dossier. Nothing to pay until you accept.
Start your review →Filing management
Our fee is quoted per product. Regulator fees are paid from your funds at exactly the quoted amount.
Start your filing →GMP clearance
Priced per site. The regulator’s own inspection fee is paid by you, at cost.
Start your GMP clearance →Everything else
Dossier pack, partner matching and distribution setup are quoted once we’ve seen your requirements.
Tell us what you need →FAQ
Fair questions.
Which regulators do these cover?
The Medicines Control Authority of Zimbabwe (MCAZ) and the South African Health Products Regulatory Authority (SAHPRA). Every tool asks which market you want, then follows that regulator’s own guidelines and screening checklist.
Is the Market Entry Check really free?
Yes. Answer six questions and your results appear straight away. We keep a copy so we can follow up if you want help.
What do I need for the dossier gap review?
Your dossier in CTD or eCTD format: Modules 1 to 5 as PDF or Word files, or one ZIP. You can also share a link instead of uploading.
Does my factory need an inspection?
It depends on the site and production line. MCAZ exempts sites in the EU, USA, Australia, Canada and Japan, and can desk-review a line already cleared by a stringent regulator or WHO. SAHPRA can rely on an approval from a PIC/S member, WHO or ZaZiBoNa under 3 years old, for the same dosage form. Otherwise the regulator inspects the site, at the manufacturer’s cost.
Can you import the product for us?
No. In Zimbabwe only a licensed importer can hold an MCAZ import permit, and customs clearing is reserved for Zimbabwean citizens. In South Africa the importer needs a SAHPRA licence to import medicines. We prepare the paperwork and coordinate the importer and a licensed clearing agent.
Which partners can you find?
Local registration holders, responsible pharmacists, pharmacovigilance providers, licensed importer-wholesalers, distributors, marketing partners, laboratories, researchers, pharmacies, healthcare professionals and medical centres.
How much does partner matching cost?
It depends on how many partners you need and what they must do. We assess your requirements first and send a quote. Nothing to pay until you accept.
Do you file with the regulator for us?
Yes, with filing management. For MCAZ we request the ZIMDIS quote, pay from your funds, submit and deliver the samples. For SAHPRA we confirm and pay the fee and submit the eCTD through its portal. Either way we track every query to the decision, and the application stays in your local holder’s name.
Who answers the regulator’s technical queries?
Your team drafts each answer, because you hold the data. Our reviewer checks it closes the query before we submit it: MCAZ allows only two review cycles, and SAHPRA three query rounds.
Is my information kept confidential?
Yes. Your dossier and plans are stored privately. We only share what a partner needs to know, and only once you agree.
Other services
Combine them.
01
Market Intelligence
A report on your medicine’s market in Zimbabwe or South Africa: registered competitors, what they charge and where they are stocked.
View service 03Marketing
Medicine marketing that meets MCAZ or SAHPRA rules and reaches the right audience, plus social media and websites for healthcare companies in Zimbabwe and South Africa.
View service