Who does what: DPML, LANACOME and CENAME

Cameroon regulates the pharmacist profession under Law No. 90-035 of 10 August 1990. As the DPML's guide quotes that law, no pharmaceutical product may be distributed in Cameroon, for payment or free, without prior authorisation from the competent regulatory authority. In practice that authorisation is the AMM (autorisation de mise sur le marché), which the Minister of Public Health decides.

The Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) sits within the Ministry of Public Health. It handles registration (homologation) of pharmaceutical products. The homologation guide on its website sets out the dossier and the process, so start there. The guide also cites a 1998 Prime Minister's decree (No. 98/405/PM of 22 October 1998) on homologation and market placement. Ask the DPML which instruments currently apply.

The national quality-control laboratory, LANACOME, says on its own website that it controls the quality of products for consumption, whether imported or made locally, and products for export. Its quality-control requirements can change, so confirm the current ones with the DPML before shipping.

The Centrale Nationale d'Approvisionnement en Médicaments et Consommables Médicaux Essentiels (CENAME) buys essential medicines for the public sector.

How the AMM process works

Medicines are filed in CTD format, the submission format in force across the CEMAC zone. The DPML's guide says only complete dossiers are received: one paper copy of Module 1 plus two USB copies of the full digital dossier. Administrative documents must be originals or copies certified by the competent authority of the country that issued them, and scanned or uncertified copies are refused.

  1. An internal evaluation sub-commission examines the dossier and writes an evaluation report.
  2. The report goes to the specialised commission for that product type, which passes its conclusions to the National Medicines Commission. For a WHO-prequalified product, a product registered by a stringent regulatory authority, or a renewal, the report goes straight to the National Medicines Commission.
  3. The National Medicines Commission advises the Minister of Public Health within a maximum of three months of filing. The minister then has two months to act on that advice.
  4. A granted AMM is valid for five years. An applicant can appeal a decision within three months of receiving it. Confirm the renewal rules with the DPML before filing.

Cameroon also takes part in WHO's collaborative registration procedures, which let a regulator rely on WHO assessments. The shorter path in step 2 changes where the report goes, and the guide does not waive the dossier for those products. Ask the DPML which route fits your product. Our note on WHO prequalification versus national registration explains the trade-offs.

Plan for delay and refusal, because practice runs longer than those limits. A 2026 study in Health Sciences and Disease reviewed DPML marketing-authorisation files for 2016 to 2023. It reported a median evaluation time of about 197 days and a refusal rate of about 69%. Product origin significantly influenced refusals. Cited refusal reasons include missing bioequivalence or stability studies, incomplete data, and labelling and leaflet defects. A complete, well-labelled dossier is the lever you control.

Who may import and wholesale

Wholesale distribution companies are approved by the Minister of Public Health. An order of 17 August 2017 (arrêté n° 2515) sets the conditions for granting that approval (agrément).

Import technical visas are filed by wholesalers the Minister of Public Health has approved, so your importer will be one of them.

A Ministry of Public Health decision of 22 February 2023 adds a step before loading. The approved wholesaler applies through SIAT on eGUCE, the foreign-trade single window, for a provisional technical visa, and goods may not be loaded in the exporting country without it. The application carries the wholesaler's agrément and distribution-practice certificate and a pro-forma invoice cosigned by the issuer and the importer's responsible pharmacist or technical director. The provisional application also carries a special import authorisation where one applies. A definitive visa application follows at loading, with a copy of the provisional visa, the distribution-practice certificate and the final invoice, cosigned the same way. Ask your importer for the provisional visa before you ship, and confirm the current procedure with the DPML.

Ask your Cameroonian partner for its current agrément and named responsible person.

Plan to ship only products with a Cameroonian AMM or a special import authorisation from the Minister of Public Health. The DPML's guide also asks for a commitment letter countersigned by a pharmacien interlocuteur, a pharmacist on the Cameroonian pharmacists' order who is the interface with the regulator, with that pharmacist's current registration certificate, so plan for a local pharmaceutical contact.

M Care Exports supplies licensed importers and procurement teams in Cameroon from India. See our Cameroon market page and the wider Africa overview.

Supplying CENAME and public tenders

CENAME buys through open tenders. National open tender 004/AONO/CENAME/CIPM/2025, issued in October 2025 under the urgency procedure, covered 11 lots of oral antibiotics, other oral medicines, dressings and external-use products. The estimated cost was 660,140,000 FCFA, with delivery within 90 days to CENAME stores in Yaoundé, and bids were due on 18 November 2025.

Eliminatory criteria included:

  • no Cameroonian AMM;
  • no authorisation to practise as a manufacturer, issued by the public health authorities;
  • no GMP certificate from the competent health authority;
  • no product leaflets or descriptive sheets in French or English;
  • missing samples or mock-ups.

Bidders also had to submit proof of at least two similar contracts and a financial-capacity attestation from a first-rank bank, at least equal to the total value of the lots bid. The tender scored both as essential criteria rather than listing them as grounds for automatic elimination. The tender states that any winner must obtain the AMM in Cameroon, or the special exemption for importing the products, before any delivery. Tender documents may set storage and packaging requirements for hot, humid climates, so check each notice's technical specifications for the stability zone and pack conditions it requires. Read each notice for who may bid. For routes in, see government supply services and NGO procurement.

Dossier language: French or English

Cameroon is officially bilingual, and the DPML's guide follows that. Dossier documents may be presented in French or English. A document in any other language must come with a sworn translation into one of the two. The CENAME tender took the same line for bids.

Labelling is stricter. The colour mock-ups of the primary and secondary packs and of the leaflet must carry their information in both languages, the leaflet is written in French and English, and the secondary pack must be at least in those two languages. Plan bilingual artwork from the start, and confirm the current rules with the DPML before filing.

The Indian-side document pack

The tender and registration sources point to a core pack from the Indian side:

  • CTD dossier for each product;
  • manufacturing licence or authorisation to practise as a manufacturer;
  • a certified copy of the current GMP certificate for every site involved in making the finished product;
  • the marketing authorisation from the country of manufacture or origin, with copies from other countries that have registered the product;
  • a free sale certificate, a Certificate of Pharmaceutical Product or proof of WHO prequalification;
  • the summary of product characteristics, and colour mock-ups of the packs and leaflet in French and English;
  • finished-product samples with batch analysis certificates, in the quantities the DPML's guide tabulates, with at least 12 months of shelf life left at filing;
  • ISO certificates and samples where a tender asks;
  • for a CENAME tender, the supplier identification questionnaire, completed in full and signed by the bid's administrative and technical heads.

M Care Exports is a merchant-exporter and does not manufacture. The dossier's technical modules and the GMP and licence documents come from the manufacturing site, so check the certificate for each site that will make your product. The guide wants certified copies, so do not plan on scans. Our CTD dossier preparation service helps assemble the pack. Buyers vetting any supplier can use the due diligence guide, then request a medicine or open a trade account.

Frequently asked

Do I need an AMM before shipping medicines to Cameroon?

Yes, treat it as the working requirement. As the DPML's guide quotes Law No. 90-035, no pharmaceutical product may be distributed in Cameroon without prior authorisation, and the Minister of Public Health decides AMM applications. Import technical visas are filed by wholesalers the Minister has approved, and the Minister also grants special import authorisations. The DPML's guide defines the applicant as a legal entity and the AMM holder as a manufacturer with an operating licence, and the dossier includes a commitment letter countersigned by a pharmacien interlocuteur registered with the Cameroonian pharmacists' order. Confirm who can file and hold the AMM for your product, and any special authorisation, with the DPML before you ship.

How long does registration take in Cameroon?

Plan for months, not weeks. The DPML's guide gives the National Medicines Commission up to three months from filing and the minister two months after that, and a granted AMM is valid for five years. Practice runs longer: a 2026 retrospective study of DPML marketing-authorisation files for 2016 to 2023 reported a median evaluation time of about 197 days and a refusal rate of about 69%, with product origin significantly influencing refusals. Confirm renewal rules with the DPML before filing. Build the dossier to avoid a refusal and a resubmission, because each round adds time.

What does LANACOME do?

LANACOME is Cameroon's national medicines quality-control laboratory. Its website says it controls the quality of imported and locally made products, and its quality-control requirements can change. We did not find a published list of what LANACOME requires from foreign applicants, such as sample quantities or methods. Ask your local applicant what it expects for your product, confirm the current requirements with the DPML, and keep specifications and analytical methods ready.

Can WHO-prequalified or stringent-authority products register faster?

Their route is shorter on paper. The DPML's guide sends the evaluation report for a WHO-prequalified product, or a product registered by a stringent regulatory authority, straight to the National Medicines Commission, without the specialised commission. Cameroon also takes part in WHO's collaborative registration procedures, which let a regulator rely on WHO assessments. The guide does not waive the dossier for these products or promise a shorter time limit, so ask the DPML what to expect. Read our WHO prequalification guide before choosing a route.

What language should the registration dossier be in?

French or English. The DPML's guide accepts dossier documents in either official language, and a document in any other language needs a sworn translation into one of the two. Labelling is stricter: mock-ups of the packs and leaflet must carry their information in both languages, the leaflet is written in French and English, and the secondary pack must be at least in those two languages. CENAME's 2025 tender also accepted bids in French or English. Confirm the current rules with the DPML before filing.

What does a CENAME tender require from a foreign supplier?

CENAME's 2025 national tender listed a Cameroonian AMM, an authorisation to practise as a manufacturer, a GMP certificate from the competent health authority, leaflets in French or English, samples, proof of at least two similar contracts and a financial-capacity attestation from a first-rank bank, scored as essential criteria rather than automatic elimination grounds. Winners had to obtain the AMM or a special import exemption before any delivery. That tender was national, so check each notice for eligibility. M Care Exports can help assemble the documents from the manufacturer for tenders and public supply.

Official sources

The regulators and official documents to check this guide against. Requirements change, so confirm the current version with the regulator before you file.

Working on this market?

Send the specifics. We will scope it honestly.

Molecule, strength, volume and destination. The Mumbai desk replies within one working day, including when the answer is that the route is not viable yet.

Request a quote → Book a meeting