French-to-English Translation of Mali’s Official Medicines List for Drug Registration

What the Malian National Nomenclature Contains

Mali’s national nomenclature is the official directory of medicines authorised for sale and distribution in the country. Published by the Direction de la Pharmacie et du Médicament (the national drug regulatory authority), the list records each product with its active substance, dosage strength, pharmaceutical form, route of administration, packaging description, registration number, and the name of the marketing authorisation holder. Some entries also include therapeutic class and storage conditions. For an Indian pharmaceutical exporter or an importer from a francophone West African market, this document is a primary reference because it confirms which products are legally recognised and provides the registration identifiers needed for dossier preparation.

Common French Terms in a Medicines List

French-language drug nomenclatures rely on a stable set of pharmaceutical vocabulary. Recognising these terms speeds up manual review and clarifies what the machine translation output contains. The table below lists terms that appear routinely across national medicines registries from Mali and neighbouring countries.

French Term	English
Liste nationale des médicaments essentiels	National essential medicines list
Substance active	Active substance
Dosage	Dosage
Forme galénique	Pharmaceutical form
Voie d’administration	Route of administration
Titulaire de l’autorisation de mise sur le marché (AMM)	Marketing authorisation holder
Numéro d’enregistrement	Registration number
Comprimé	Tablet
Injectable	Injectable
Conditionnement	Packaging

Why Translate a Drug List for Regulatory Compliance

Indian pharmaceutical companies exporting to Mali or importing Malian-authorised products need an English version of the nomenclature for several practical reasons. Regulatory affairs teams build drug registration dossiers that must reference exactly the authorised active substances and strengths listed by the importing country. English-speaking regulators, whether at the Central Drugs Standard Control Organization (CDSCO) in India or at the counterpart authorities in non-francophone markets, expect supporting documentation in English. An English translation also helps in-house quality assurance, import licensing, and communication with logistics partners. Without a reliable English version, critical details such as registration codes, dosage forms, and manufacturer names remain locked in French, slowing every downstream step.

AI Translation vs On-Demand Certified Translation for Drug Filings

When you translate a medicines list through Lekhak’s self-serve AI, the platform returns an instant DOCX that is fully suitable for internal review, pre-submission cross-checking, or building draft dossiers. The AI output faithfully renders every term, registration number, and dosage value in English while keeping the original table structure intact. Because the result is a best-effort machine translation, it is not itself a signed certificate of accuracy. If your filing, for example, a DCGI application, a tender response, or a registration dossier, specifically requires a certified translation, Lekhak also offers certified translation on-demand, which you can request separately and which includes a signed certificate of accuracy. The sections that follow explain where the separate attestation chain fits.

What Your Lekhak AI Translation Will Include

Your translated DOCX will mirror the source document’s table layout. Each drug entry is rendered as a row of columns, with every French field mapped to its English equivalent. The AI preserves all identifiers exactly as they appear: registration numbers, marketing authorisation codes, dosages, and packaging descriptions. For example, a row might read:

• Active substance: Ceftriaxone (as sodium salt)
• Dosage: 1 g
• Pharmaceutical form: Powder for injection
• Registration number: [REGISTRATION NO]
• Marketing authorisation holder: [MANUFACTURER NAME]

The output file is a fully editable, searchable DOCX. You can immediately add notes, highlight entries, or copy parts of the list into a regulatory dossier. No additional formatting steps are required.

Notarisation, Apostille, and Embassy Attestation for Pharmaceutical Documents

If a translated drug list needs to be used for a legal or official filing, for instance, when accompanying an application to a drug regulatory authority that demands formally authenticated documents, you may need to follow an attestation chain. A certified translation (available from Lekhak on-demand) provides a signed certificate of accuracy, which is often the first step. After that, notarisation (if required) and apostille are separate government procedures. For documents destined for countries that are members of the Hague Apostille Convention, India’s Ministry of External Affairs attaches the apostille; for non-Hague countries, additional embassy legalisation may be needed. Indian CDSCO submissions typically require certified accuracy, not apostille, but you should verify the exact specifications with the receiving authority. Neither notarisation nor apostille is performed by Lekhak, they are independent acts you arrange directly with the competent offices.

Regional Context: Francophone African Drug Lists and Indian Regulatory References

Mali’s national nomenclature broadly aligns with the WHO Model List of Essential Medicines, making it structurally similar to lists published by other West African francophone countries such as Senegal, Burkina Faso, and Côte d’Ivoire. The Malian Direction de la Pharmacie et du Médicament issues updates periodically, and registrations are recorded under a national marketing authorisation framework. On the Indian side, the Drugs and Cosmetics Act, 1940 and the rules framed under it govern drug manufacture, import, and registration. CDSCO, as the national regulatory authority, reviews submissions that often reference foreign drug registries. From our experience with pharmaceutical regulatory documents, having an English version of a source country’s authorised-product list reduces the back-and-forth during dossier preparation and helps alignment with Indian registration requirements.

FAQ

What exactly is the Malian national nomenclature?

It is the official list of medicines authorised by Mali’s drug regulatory authority. The document records active substances, dosages, pharmaceutical forms, registration numbers, and marketing authorisation holders for products allowed on the Malian market.

Do I need a certified translation for a DCGI application?

DCGI submissions often require a certified translation when the source document is in French. While an AI draft is ideal for internal preparation, the formal filing may call for a signed certificate of accuracy, which Lekhak can provide on-demand as a separate request.

How long does Lekhak’s AI translation take for a 30‑page medicines list?

The self-serve AI pipeline processes a multi-page PDF within minutes. The translated DOCX is available for download as soon as the engine finishes the OCR and translation steps, typically well under the time it takes to manually review even a few pages.

Can Lekhak handle scanned PDF copies of the nomenclature?

Yes. The platform applies OCR to image-based PDFs before translation. As long as the scan is legible, the AI extracts the text, recognises the table layout, and delivers a clean, editable DOCX.

Does Lekhak provide notarisation or apostille services?

No. Lekhak’s AI translation is a self-serve digital output, and the on-demand certified translation includes a certificate of accuracy. Notarisation, apostille, and embassy attestation are separate government acts you arrange with the appropriate authorities.

In what file format will I receive the English version?

The translation is delivered as an editable DOCX file. The original table structure, columns, and cell placements are preserved, and you can search, modify, and copy content freely.

Is the translation editable and searchable?

Yes. The DOCX output is fully editable and searchable. You can use standard word-processor tools to find specific drug entries, highlight sections, or add notes for regulatory reviewers.

Will the translation keep table columns and formatting intact?

The AI reproduces the source document’s table layout, mapping each column header and cell content into the English version. Font styles, merged cells, and multi-row entries are retained wherever technically possible.

Are active substance names standardised to International Nonproprietary Names (INN)?

The AI translates the substance names using pharmaceutical terminology models. While it aims for INN equivalents, you should verify the final spelling against the official WHO INN list, especially for less common or combination products.

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