Why Farbe Firma is the Leading Injectable Manufacturer in Vanuatu
Why Farbe Firma is the Leading Injectable Manufacturer in Vanuatu
Last Updated: 16 September 2026
TL;DR: Vanuatu does not appear to operate pre-market product registration for medicines. The Sale of Medicines (Control) Act [CAP 48], as amended in 2014, regulates who may import and wholesale rather than which products may be sold, and the decisive check is a post-arrival release decision by the Principal Pharmacist. The practical gate is therefore your Vanuatu counterparty and the quality file you hand them, not a dossier queue.
Key Takeaways
The governing instrument is the Sale of Medicines (Control) Act [CAP 48], commenced in 1966 and substantially amended by Act No. 8 of 2014, which came into force on 17 July 2014.
We found no pre-market registration requirement and no published list of recognised foreign regulators or approved countries of origin. That is a "not found", not a proven absence, and it should be confirmed with the Ministry of Health rather than assumed.
Section 3A is the provision that matters: Customs records each importation and sends the list to the Principal Pharmacist, who may approve or refuse release and may attach conditions - a check that can happen after your goods have landed.
Vaccines are a separate channel entirely, running through the UNICEF Vaccine Independent Initiative pooled mechanism, where UNICEF's supplier rules apply rather than Vanuatu's import route.
Introduction: What an Injectable Manufacturer in Vanuatu Actually Has to Clear
Vanuatu is a market of roughly 330,000 people spread across some eighty islands, and that geography shapes its medicines supply more than any single regulation does. For an exporter the first question is usually "what do I have to register, and with whom?" In Vanuatu that question has an unusual answer, and getting it wrong in either direction is expensive - a supplier who assumes a heavy registration regime will price in work that may not exist, while one who assumes no control at all will meet section 3A at the wharf.
The operative instrument is the Sale of Medicines (Control) Act [CAP 48], first commenced in 1966 and substantially amended by Act No. 8 of 2014, in force from 17 July 2014. Read on its face, that Act regulates persons and premises rather than products. It sets out who may import and wholesale medicine; it does not establish a marketing authorisation, prescribe a dossier, or name a single foreign regulator. Vanuatu's own National Medicines Policy 2015-2020 describes it as "an aspiration" that medicines used in the country should be registered - language a government does not use about a system it already runs.
What Sets a World-Class Injectable Manufacturer in Vanuatu Apart
What separates a serious supplier here is knowing which door actually opens. Under section 3(1), a person intending to be a wholesale supplier of medicine must first obtain the prior written approval of the Pharmacists Practitioners Commission, and under section 3(2) an approved wholesaler may supply only a licensed medical practitioner, pharmacist, licensed dentist, licensed veterinarian, or a person approved by the Minister by Order. The gate is the counterparty. An exporter without an approved Vanuatu wholesaler has no route in, however good the product is.
Then comes section 3A, which is where careless shipments come undone. The Director of Customs records each importation of medicine for sale and forwards the list to the Principal Pharmacist, who may approve or refuse the release of those medicines, must give reasons for a refusal, and may attach conditions to any approval. That is a discretionary power exercised on goods that have already travelled. The way to make it straightforward is to arrive with a file that answers the obvious questions before they are asked, rather than to argue about them from a container yard.
Quality Systems Behind Every Batch Shipped to Vanuatu
Farbe Firma manufactures sterile injectables under WHO-GMP certification at ISO Class 5 aseptic filling, with in-house HPLC, GC, LAL endotoxin and Karl Fischer testing, and stability studies run to ICH Q1A and Q1B. Every batch ships with a certificate of analysis traceable to retained samples. We prepare CTD and ACTD dossiers as standard, and we can supply a WHO-format CPP on request - not because Vanuatu's statute demands one, but because it is the document that makes a discretionary release decision easy for the person making it.
Two points deserve an honest word rather than a sales one. First, Vanuatu's National Medicines Policy gives priority in public procurement to medicines prequalified by WHO, with current WHO-scheme certification as the stated fallback - but that is a procurement policy, not a statutory import condition, and it was written for the period 2015-2020. Second, India's CDSCO appears on WHO's transitional WHO-Listed Authority list with its scope limited to vaccines, so no Indian supplier should present CDSCO as a listed authority for medicines generally. We would rather tell you that than let you discover it in a tender.
Why Farbe Firma is the Trusted Injectable Manufacturer in Vanuatu for Global Buyers
The most expensive error in a Pacific file is not a technical one. It is assuming that because a national gate is open, there is no gate at all. Vanuatu's national route appears genuinely permissive on the face of the statute, and we have found nothing excluding Indian-manufactured medicines from it. But the same is not automatically true of every channel that supplies the country, and treating the three as one is how suppliers lose a year.
So we separate them. National law asks who you sell through and whether the Principal Pharmacist will release the consignment. Public-sector supply is a different question: procurement is limited to Vanuatu's Essential Drug List and runs through the Central Medical Store under Ministry of Finance procurement guidelines, using bulk contracts, standing offer agreements with preferred suppliers, and requests for quotation. The contract references the Ministry publishes date from 2016-2018, so current arrangements have to be confirmed directly rather than read off a website.
Vaccines are a third question again. Vanuatu obtains them through the UNICEF-managed Vaccine Independent Initiative, a pooled mechanism covering eleven Pacific island countries, which means a vaccine supplier must satisfy UNICEF Supply Division's own qualification rules - a channel that can exclude a supplier the national route would admit. What we offer is not a promise that every door is open, but a clear account of which is which, a dossier built to the format each one expects, and the batch documentation to survive scrutiny at any of them.
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Frequently Asked Questions (FAQ)
Do I need to register each product with the Ministry of Health before importing?
We found no pre-market product registration requirement in Vanuatu law. CAP 48 as amended in 2014 regulates who may import and wholesale, not which individual products are approved, and the National Medicines Policy 2015-2020 still describes registration as an aspiration. Treat that as "no requirement found" rather than "confirmed no requirement": not every Order made under section 7 was accessible to us, and the Principal Pharmacist can attach conditions to any consignment. Confirm with the Office of the Principal Pharmacist before you ship.
Is India on a Vanuatu list of approved countries or recognised regulators?
No such list was found, and no legal instrument creating one was found either. There is therefore no basis for saying Indian-manufactured medicines are excluded - and equally none for saying they are formally recognised, because there appears to be nothing to be recognised by. That is an open question to put to the Ministry of Health, not a settled position in either direction.
What dossier format does Vanuatu accept - CTD, ACTD or eCTD?
No instrument prescribing any dossier format was found, which is unsurprising given that no registration route was found for a format to attach to. We supply CTD and ACTD as standard because they travel well across the region and because a well-organised file is what makes a section 3A release decision quick. We would not tell you Vanuatu requires CTD, because we have seen nothing that says so.
Is a WHO-GMP certificate and a CPP enough to clear customs?
For public tenders, the National Medicines Policy puts WHO prequalification first and current WHO-scheme certification second, so a CPP addresses the stated policy expectation. For private commercial import we found no statutory CPP requirement. Neither document is a legally sufficient condition, because the release decision under section 3A is discretionary - but carrying both is the practical way to make that decision uncontroversial.
How large is the India-Vanuatu pharmaceutical trade?
We cannot give you a reliable figure, and we would rather say so than pick one. The UN COMTRADE series as republished by aggregators ends in 2011 at about US$2.14 million, while mirror data reported from the Indian side has been quoted at around US$1.11 million for 2024. Those are different reporters, different years and different directions of a mirror pair, and we are not in a position to reconcile them.
Technically Reviewed By: Maulik Sudani (Technical Expert) | Jignasu Sudani (Technical Expert), Farbe Firma Pvt Ltd, Gujarat, India.
Farbe Firma Pvt Ltd - WHO-GMP certified sterile injectable manufacturer and CDMO, Gujarat, India. ISO Class 5 aseptic filling, CTD/ACTD dossiers, exporting to 30+ countries. director@farbefirma.orgRequest a Quote / View Products / Blog
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