Country guide · West Africa · UEMOA · Francophone
Burkina Faso drug registration: ANRP homologation, now handled by Faso FDA
For importers in Ouagadougou and Indian exporters of generics: who grants the AMM today, what goes into the French CTD dossier, how long it really takes, and what changed after Burkina Faso left ECOWAS but stayed in UEMOA.
ANRP (Agence nationale de régulation pharmaceutique) no longer operates as a separate agency. Decree n°2026-0602/PF/PRIM/MEF/MS of 22 May 2026 created the Faso Food and Drug Administration (Faso FDA) by merging ANRP with ANSSEAT[1][2]. The old anrp.bf address now redirects to fasofda.bf. Faso FDA’s portal still links to the ANRP-era online registration system (RIMS) and publishes the ANRP-era homologation and fee texts[7]. Any guide that still tells you to “apply to ANRP” is describing the same function under its old name.
The short answer
Burkina Faso drug registration means getting an autorisation de mise sur le marché (AMM). The application goes to Faso FDA (formerly ANRP) under UEMOA Regulation n°04/2020/CM/UEMOA. You file a CTD dossier (four modules for a generic), with Module 1 and the labelling in French, plus a CPP, GMP evidence, certificates of analysis, samples and the fee[4][6]. The regulation’s assessment clock is 120 days, which can stretch to a maximum of 360 days while questions are outstanding. In practice, consultants report 9 to 18 months[4][13]. The AMM lasts five years, covers Burkina Faso only, and a product can be imported only once it is registered.
- RegulatorFaso FDAFormerly ANRP, merged May 2026
- Legal basisReg. 04/2020UEMOA, replaced Reg. 06/2010
- Review clock120 daysUp to 360 days with queries
- AMM validity5 yearsNational only; renew 120 days early
- CurrencyXOFCFA franc, still in UEMOA
Who grants the AMM in Burkina Faso now: ANRP or Faso FDA?
Faso FDA. The government approved the merger in the Council of Ministers on 12 March 2026[3], and the founding decree followed on 22 May 2026[2]. ANRP had run marketing authorisation, establishment licensing, pharmacovigilance, market surveillance, inspections and clinical-trial oversight. Faso FDA takes all of that over, and adds food, cosmetics, pesticides and laboratory testing from ANSSEAT[2].
For an exporter this matters in three ways:
- Address your file to Faso FDA. Write to infos@fasofda.bf or +226 53 83 41 42 (Boulevard des Tensoba, Ouagadougou)[1]. Old ANRP letterheads and email addresses may not reach anyone.
- Expect the old rules to apply for now. The homologation texts Faso FDA publishes are still the ANRP-era ones: the 2020 order creating the homologation commission, the 2003 order on AMM conditions, and the annex to UEMOA Regulation 04/2020[7]. The decree’s transition article deals with staff and assets. It does not say whether existing AMMs or procedures change[2]. UNVERIFIED Regulatory monitors report that existing obligations continue until Faso FDA issues new procedures, but we found no Faso FDA notice confirming it.
- Enforcement is active. In autumn 2026 Faso FDA banned an unregistered “dengue” product because it was absent from the 2026 national list of authorised medicines[14]. Check that list before you quote a buyer.
ECOWAS exit vs UEMOA membership: what changed for medicines
Burkina Faso, Mali and Niger stopped being ECOWAS members on 29 January 2025[10]. They did not leave UEMOA (WAEMU). As of September 2026, all three were still in the union, and the CFA franc (XOF) was still their currency[11]. Medicine registration in Burkina Faso has always run on UEMOA texts, so the exit did not change the legal route to an AMM.
| Topic | Position (Nov 2026) | What it means for you |
|---|---|---|
| ECOWAS membership | Ended 29 Jan 2025. ECOWAS said goods would still be treated under its trade liberalisation scheme until further notice[10] | Don’t describe Burkina Faso as an ECOWAS state in tenders or dossiers. Some 2026 market overviews still do[13] |
| UEMOA membership | Still a member (Sep 2026)[11] | Regulation 04/2020 governs the dossier, the timelines and the AMM validity |
| Currency | CFA franc (XOF); no AES currency in place[11] | Price in USD or EUR FOB. The buyer’s bank converts from XOF |
| Import levy | 0.5% AES confederal levy on the customs value of goods from non-AES countries, in place of the old 0.5% ECOWAS levy[12] | Indian goods pay 0.5% either way, so your landed cost is unchanged |
| WAHO CTD guideline (June 2018) | An ECOWAS (WAHO) document[6] | Still a useful template for module layout, but the binding text for Burkina Faso is the UEMOA annex |
| Joint regional assessment | UNVERIFIED Whether Burkina Faso can still use ECOWAS joint-assessment routes after the exit | Plan on a national AMM. UEMOA has no mutual recognition: the AMM is national only[4] |
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Conflicting sources. A 2025 tender clarification for a Burkina Faso project says products already registered in a UEMOA or ECOWAS state get “simplified procedures (partial mutual recognition)”, but still need a local AMM[15]. The 2026 academic review of Regulation 04/2020 says the regulation provides no mutual recognition. The only shortcut it describes is an abridged dossier for products from ICH regions or WHO-prequalified products[4]. Until Faso FDA confirms otherwise in writing, plan for a full generic dossier.
The ANRP / Faso FDA homologation dossier: CTD in French
Regulation 04/2020 sets a five-module CTD for new products and vaccines, and four modules for generics (generics have no Module 4). Module 1 gained extra items in 2020, Module 2 now needs both a QOS and a QIS, and 22 changes that used to be minor variations are now major[4]. Pick a module to see what to prepare.
Module 1: administrative and regional (in French)
- Cover letter and signed application form. Proof of fee payment in the form Faso FDA prescribes[6].
- Certificate of Pharmaceutical Product (CPP, WHO format) if the product is not registered in India for sale. Also certificates of analysis, GMP status with the last inspection date, and letters giving access to the DMF or site master file[6].
- A notarised power of attorney if the applicant is not the manufacturer[6].
- RCP (SmPC), patient leaflet and label mock-ups in French. The UEMOA annexes require the RCP and labelling in the official language of the member state. For a single-country file, Module 1 is in that country’s language[5][6].
- Since 2020: copies of earlier notifications, correspondence with the regulator, and the BTIF (bioequivalence trial information form)[4].
Module 2: summaries
- Quality Overall Summary (QOS) and Quality Information Summary (QIS). Both are required under the 2020 revision[4].
- Clinical and bioequivalence summaries for a generic. Keep the numbers identical to Modules 3 and 5: assessors check them against each other.
Module 3: quality
- API information (open/closed DMF or a CEP), finished-product specifications, process validation and batch analyses.
- Stability data, plus a stability summary and a post-approval stability protocol. The WAHO guideline refers to ICH Q1A to Q1E and WHO TRS 953 Annex 2[6]. VERIFY Confirm with Faso FDA which climatic-zone conditions it expects before you place batches on stability. Hot-climate markets usually ask for zone IVb data (30 °C / 75% RH).
- The manufacturing site in Module 3 must match the site named on the CPP and the GMP certificate.
Module 5: bioequivalence
- Pivotal comparative bioavailability study reports, with the BTIF in Module 1[6].
- Biowaiver requests go in Module 1 and must be justified under the relevant biowaiver guidance[6]. Simple oral solutions and some topicals are common waiver candidates, but each waiver is argued product by product.
- Generics need the reference product’s RCP for comparison[6].
Documents an Indian exporter supplies: CPP, WHO-GMP, CoA, samples
| Document | Issued by | Points that cause rejections |
|---|---|---|
| CPP (WHO format) | Indian regulator under the WHO Certification Scheme | It must name the actual manufacturing site and match Module 3. A CPP is accepted as the export marketing-authorisation document[5] |
| WHO-GMP certificate | Indian regulator | Must be valid at submission, for the same site and dosage-form block. The UEMOA annexes also ask for the manufacturing licence and the release site’s qualified-person commitment[5] |
| Certificates of analysis | Manufacturer QC | The batches on the CoAs should be the batches in stability and the batches the samples come from |
| Samples | Manufacturer | Under the 2010 annex: up to 30 unit packs (or 10 hospital packs) for a generic, with at least 18 months’ remaining shelf life[5]. VERIFY Confirm the 2020 quantities with Faso FDA |
| Free Sale Certificate | Indian regulator | Buyers often ask for it as well as the CPP. Check whether Faso FDA wants it on file |
| Fee receipt | Applicant | Pay in the form Faso FDA prescribes, and file the receipt in Module 1[6] |
| French product information | Applicant (certified translation) | RCP, leaflet and labels. The applicant answers for translation accuracy[6] |
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For a fuller pre-shipment list, see our pharmaceutical export documentation checklist (CoA, WHO-GMP, CoPP, FSC, certificate of origin). To test what you receive before you rely on it, see how to verify medicine quality before import.
Burkina Faso registration process and timeline, step by step
- Check the national listWeek 0Search Faso FDA’s nomenclature of authorised products[1]. If your brand is already registered, you import against that AMM. If only the molecule is listed, you still need your own AMM.
- Decide who holds the AMMWeeks 0 to 2Either the manufacturer or the Burkina importer can apply, with a power of attorney if the applicant is not the manufacturer[6]. UNVERIFIED Whether a foreign holder must appoint a local representative in Burkina Faso. Confirm with Faso FDA.
- Build the CTD and translate Module 1Weeks 2 to 10QOS and QIS, stability, BTIF, and French RCP and labels. Run a stability check before anything else.
- Submit, pay, send samplesDay 0 of the clockFile through Faso FDA. Its portal links to the ANRP RIMS online registration dashboard[1]. The 2010 annexes asked for the application form two months ahead of the dossier[5].
- Evaluation and the homologation commissionUp to 120 daysThe legal clock is 120 days. It pauses while you answer questions, up to a maximum of 360 days[4]. Burkina Faso’s homologation commission and committees were set up by orders in 2020[7].
- AMM grantedRealistic: 9 to 18 monthsA consultancy that files in Burkina Faso puts real-world timelines at 9 to 18 months, depending on dossier quality[13]. That figure is the consultancy’s experience, not a legal limit.
- Import, then maintain5-year cycleRegistered products can be imported. Apply to renew 120 days before expiry. Late renewal now carries penalties, and variations take up to 120 days[4].
Burkina Faso registration fees (redevances)
UEMOA kept the registration fees introduced in 2010 and added penalties for late renewal. It leaves the amounts and how they are collected to each member state[4]. Faso FDA’s fees page lists three texts: Arrêté conjoint n°2020-156 on ANRP fees and charges, Arrêté conjoint n°2020-451 on how ANRP services are paid for, and an ANSSEAT price grid dated 20 August 2024[8].
UNVERIFIED We have not printed fee amounts. The official schedules are scanned PDFs we could not read reliably, and the merger may change them. Before you budget, ask Faso FDA (infos@fasofda.bf) for the current schedule for a new generic AMM, a renewal and a variation. Treat any figure from a third-party website as indicative until the regulator confirms it. To see how other regulators in this series compare, read our Ghana FDA registration fees and Africa fee comparison.
Import medicines from India to Burkina Faso after registration
Medicines can be imported only after they are registered[13]. Faso FDA’s import and export page publishes the ANRP-era rules that still frame this[9]:
- A 2020 circular on securing the supply of health products, and another on exceptional import derogations in public procurement.
- Circulars banning irregular supply to hospital pharmacies.
- Orders on free promotional samples and on poisonous substances. Check the poisonous-substances order (Arrêté n°2015-845) for anything abuse-prone.
- A joint order on the Autorisation Spéciale d’Importation (ASI).
VERIFY The page lists these texts but does not set out the per-shipment authorisation step for a registered product. Confirm the current import authorisation or visa process with your importer and Faso FDA before the first shipment. Public-sector supply runs through CAMEG, the central purchasing agency for essential generics and medical consumables, and through public tenders. Private supply runs through licensed wholesalers.
Burkina Faso is landlocked. Sea freight from India lands at a coastal port and goes on by road, so freight, transit and the 0.5% levy belong in your landed-cost model. See landed cost of medicines from India to Africa.
Which route fits your product? A 30-second check
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A real Burkina Faso enquiry, mapped to registration work
This list came to us from a Burkina Faso buyer through an Indian intermediary. The buyer asked for private-label prices, MOQ, lead time, a CTD dossier, CPP/FSC, WHO-GMP and CoA. Here is how each item lines up with the AMM work it needs.
| Product and pack | Where Puizer makes it | Registration notes |
|---|---|---|
| Amlodipine 5 mg and 10 mg tablets, 10×10 Alu-PVC | Own WHO-GMP facility, Sonipat, Haryana | Each strength is its own presentation in the dossier. Plan for BE data or a justified biowaiver |
| Azithromycin 500 mg tablets, 1×3 | Own WHO-GMP facility, Sonipat | Hot-climate stability data for the blister. BE expected for an oral solid |
| Albendazole 200 mg/5 mL suspension, 10 mL PET | Partner facility under loan licence | The CPP and GMP certificate name the partner site, so Module 3 must too. Include in-use and suspension stability |
| Terbinafine 1% cream, 30 g tube | Partner facility under loan licence | Tube-compatibility and stability data. Waiver arguments for topicals are made product by product |
| Ferric combination syrup, 200 mL | Partner facility under loan licence | Fix the exact composition first. A combination needs a rationale and must match the national list or be justified |
| Gabapentin 300 mg capsules | Enquiry only | Abuse-prone. We handle it on enquiry only and don’t promote it. Check its status under Burkina Faso’s poisonous-substances rules first[9] |
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We confirm CTD dossier availability in Burkina Faso format product by product, in the quote. Certificate numbers are shared on request. We make injections through a third party, and we hold no HALAL certification. Many of these molecules are on the list in our guide to essential generic medicines from India for Africa.
- Payment
Advance T/T only.
- Incoterm
FOB Indian port.
- Private-label lead time
45 to 60 days after artwork approval.
- MOQ
Typical ranges, confirmed per quote. See MOQ and commercial terms.
Registering in Burkina Faso? Send us your product list
Tell us the molecules, strengths, packs and who will hold the AMM. We will reply with private-label pricing, MOQ ranges, and which products we can support with a CTD dossier, CPP and WHO-GMP evidence.
Burkina Faso drug registration FAQ
Not as a separate agency. Decree n°2026-0602 of 22 May 2026 merged ANRP and ANSSEAT into the Faso Food and Drug Administration (Faso FDA), which now handles medicine registration (AMM), licensing, inspection and pharmacovigilance. The old anrp.bf website redirects to fasofda.bf.
UEMOA Regulation n°04/2020/CM/UEMOA, which replaced Regulation n°06/2010 in September 2020. National orders add to it, such as the 2003 order on AMM conditions and the 2020 orders setting up the homologation commission.
The UEMOA regulation sets a 120-day assessment clock. It can run to a maximum of 360 days while the regulator waits for answers. Consultants report 9 to 18 months in practice, depending on how complete the dossier is.
Yes, for the parts the regulator and patients read. Module 1, the summary of product characteristics (RCP), the patient leaflet and the labels should be in French. Technical modules are often accepted in English, but confirm this with Faso FDA before you file.
Five years, and it is valid in Burkina Faso only. Apply to renew 120 days before it expires. The 2020 regulation added penalties for late renewal, and each member state sets the amount.
Registration runs on UEMOA rules, and Burkina Faso is still in UEMOA and uses the CFA franc, so the legal route to an AMM is unchanged. On tax, a 0.5% AES confederal levy replaced the 0.5% ECOWAS levy on goods from outside the bloc. Indian imports pay the same rate as before.
Not for commercial sale. Medicines can be imported only after registration. Narrow exceptions exist for public procurement and special import authorisations, and Faso FDA actively removes unregistered products from the market.
Related on Puizer Cure
References
- Faso Food and Drug Administration. Portail officiel de Faso FDA (créé par décret n°2026-0602/PF/PRIM/MEF/MS du 22 mai 2026). Ouagadougou: Faso FDA; 2026. Available from: https://fasofda.bf/fr/?p=21911. Accessed Nov 2026.
- Ouoba K, Nyambayo PPM, Dori D, Ashie A, Onu K, Semdé R. Faso Food and Drug Administration (Faso FDA): strengthening regulatory systems for public health protection in Burkina Faso. Front Drug Saf Regul. 2026;6:1880709. doi:10.3389/fdsfr.2026.1880709. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC13713830. Accessed Nov 2026.
- Gouvernement du Burkina Faso. Compte rendu du Conseil des ministres n°009 du 12 mars 2026. Ouagadougou; 2026. Available from: https://burkina24.com/wp-content/uploads/2026/03/CONSEIL-DES-MINISTRES-N%C2%B0009-DU-12-MARS-2026.pdf. Accessed Nov 2026.
- Alloukou-Boka PM, Amonkou-N’guessan AC, Minyem Ngombi-Afuh AP, Amari AS. Révision des procédures d’homologation des médicaments à usage humain au sein de l’UEMOA : quelles évolutions ? J Afr Technol Pharm Biopharm. 2026;5(1). doi:10.57220/jatpb.v5i1.222. Available from: https://www.soapgi-jatpb.org/index.php/jatpb/article/download/222/57. Accessed Nov 2026.
- Union Économique et Monétaire Ouest Africaine. Annexes au Règlement n°06/2010/CM/UEMOA relatif aux procédures d’homologation des produits pharmaceutiques à usage humain. Ouagadougou: Commission de l’UEMOA; 2010. Available from: https://new.sante.gouv.bj/bibliotheque/document/DO00001030/download. Accessed Nov 2026.
- Organisation Ouest Africaine de la Santé (OOAS/WAHO). Enregistrement des produits pharmaceutiques à usage humain au sein de la CEDEAO : lignes directrices pour la préparation et la soumission des dossiers en format CTD. Bobo-Dioulasso: OOAS; 2018. Available from: https://www.wahooas.org/web-ooas/sites/default/files/appels-doffres/2003/ctdfr-lignes-directrices-pour-la-preparation-et-la-soumission-des-dossiers.pdf. Accessed Nov 2026.
- Faso FDA. Homologation des produits de santé : médicaments et vaccins (Arrêté n°2020-162; Arrêté n°2020-270/MS/CAB du 12 août 2020; Arrêté n°2003-341/MS; Annexe au Règlement n°04/2020/CM/UEMOA). Available from: https://fasofda.bf/fr/appGestion/listeCategoriePublic/4dd6d86e-db5c-4e9f-a831-76e6a3ce627c/. Accessed Nov 2026.
- Faso FDA. Frais prestations (Arrêtés conjoints n°2020-156 et n°2020-451; Grille tarifaire ANSSEAT du 20 août 2024). Available from: https://fasofda.bf/fr/appGestion/listeCategoriePublic/408aaf9b-e467-4caa-9ed3-62e9e40387e2/. Accessed Nov 2026.
- Faso FDA. Importation / Exportation (circulaires ANRP 2019–2020; Arrêté n°2015-845/MS/CAB; Arrêté conjoint n°2018-0333 MCIA-MINEFID). Available from: https://fasofda.bf/fr/appGestion/listeCategoriePublic/b95f8e3d-394b-4c54-854f-7dbc58ba12d6/. Accessed Nov 2026.
- ECOWAS Commission. Burkina Faso, Mali and Niger’s withdrawal from ECOWAS is now a reality. Abuja: ECOWAS; 30 Jan 2025. Available from: https://www.ecowas.int/burkina-faso-mali-and-nigers-withdrawal-from-ecowas-is-now-a-reality/. Accessed Nov 2026.
- The Rio Times. Mali, Burkina Faso, Niger launch AES Sahel confederation parliament as currency plans lag. 6 Sep 2026. Available from: https://www.riotimesonline.com/sahel-aes-confederation-economy-2026/. Accessed Nov 2026.
- TelQuel. L’Alliance des États du Sahel établit un droit de douane commun. 1 Apr 2025. Available from: https://telquel.ma/instant-t/2025/04/01/lalliance-des-etats-du-sahel-etablit-un-droit-de-douane-commun_1924593/. Accessed Nov 2026.
- AREMA International. Country overview Burkina Faso: important market and regulatory information. 19 Jan 2026 (secondary source; its ECOWAS membership statement is out of date). Available from: https://arema-international.com/country-overview-burkina-fasso-important-market-and-regulatory-information/. Accessed Nov 2026.
- Ouest Info. Santé : « DengueMed », un produit interdit au Burkina Faso. 2026. Available from: https://www.ouestinfo.bf/sante-denguemed-un-produit-interdit-au-burkina-faso/. Accessed Nov 2026.
- Enabel. Clarifications, marché BFA23002-10037 : acquisition de médicaments pour les districts sanitaires de Boromo et de Dédougou. 2025 (tender document, secondary). Available from: https://www.enabel.be/app/uploads/2025/04/BFA23002-10037_Clarifications.pdf. Accessed Nov 2026.
Disclaimer. This guide is technical and educational information for importers and exporters. It is not legal, regulatory or medical advice. Burkina Faso’s regulator was restructured in 2026, and UEMOA and national texts change. Confirm fees, sample quantities, local-representation rules and import authorisation steps with Faso FDA before you file or ship. Items marked UNVERIFIED or VERIFY could not be confirmed from a primary source on 13 November 2026.
