Commercialisation · Module 1
Zimbabwe dossier pack
You already have Modules 2 to 5, because they’re the same in every country. We build Module 1, the part that is specific to Zimbabwe, and get your samples ready to ship.
What we do
MC8, cover letter and declarationThe MCAZ application form, a cover letter naming your local applicant, and the applicant’s declaration.
Screening checklist (EVRF 30)Filled in item by item, so screening finds everything where it expects it.
QIS and, for generics, the BE formThe quality information summary (EVRF 73) and the bioequivalence trial information form (EVRF 03), in Word as MCAZ asks.
Labels and leafletsLabels, the patient leaflet and the prescriber’s leaflet, formatted to the SADC labelling guideline.
GMP and approvals elsewhereCopies of the GMP certificates and your approvals from other countries, collated and checked.
SamplesYour samples with MCAZ’s sample submission form (SR 06), ready to ship.
Someone qualified has to sign the declaration. If you don’t have that person, we arrange one.
What we need from you
- Modules 2 to 5. We take the quality summary, specifications and bioequivalence data from these. A zipped dossier is fine.
- Current SmPC, leaflets and label artwork. In Word if you have it, and colour artwork for every pack.
- GMP certificates. For every finished-product site, packer and active-ingredient site.
- Registration certificates or CPP. From the country of origin and anywhere else it’s approved.
- CEP, WHO CPQ or DMF letter of access. Whichever documents the active ingredient.
- Certificates of analysis. For the batch the samples come from. Can follow later.
How it works
- 1Tell us about itA few questions and your documents. About ten minutes.
- 2Get your quoteWithin one business day. Nothing to pay until you accept.
- 3We do the workWith MCAZ and the people involved, so you don’t have to.
- 4Follow it liveYour own status page shows progress, documents and every deadline.
Pricing
Quoted per product once we’ve seen your Modules 2 to 5. Nothing to pay until you accept.
Confidential. Your documents are stored privately and never shared without your say.