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Mali Drug Product Registration

Ministry of Health and Social Development Mali Pharmaceutical Registration Requirements

Ministry of Health (MoH): Ministry of Health and Social Development (Ministère de la Santé et du Développement Social)

Website: http://www.sante.gov.ml/

Regulatory Authority Name: Directorate of Pharmacy and Medicine (Direction de la Pharmacie et du Médicament – DPM)

Regulatory Authority website: http://www.sante.gov.ml/

Official Language: French /English

Local Authorised Representative: Yes

Classification: New Drug, Generic Drug, Biologic, Biosimilar.

Registration Timeline: 3 to 12 months

License Validity: 5 Years

Management of Applications and Standard Operating Procedures

An abbreviated abstract file will be required for pharmaceutical products that have been evaluated by a strict drug regulatory authority, as well as those that have been pre-qualified by the World Health Organization.

For other products, including products for specific or neglected tropical diseases, full documentation will be required.

GENERAL POLICIES ON APPLICATIONS:

A distinct application is necessary for each product. To provide clarification, a single application may be submitted for products that share identical active ingredients, strength, manufacturer, manufacturing site, specifications, and dosage form, differing solely in packaging or pack sizes. Conversely, separate applications must be submitted for products containing the same active ingredient(s) but with variations in salts, strength, dosage form, and proprietary or brand name. This policy aims to ensure clarity in the regulatory process and appropriately addresses the nuances associated with different product characteristics.

Classes of Applications

Applications shall be classified into three

  • New Applications
  • Renewal of applications (i.e., registration)
  • Variation of Applications (i.e., of a registered product)

New Applications:

Applications for the registration of a pharmaceutical product, whether submitted to the Director General of WAHO for region-wide market authorization or to a specific National Medicines Regulatory Authority (NMRA) in the region for the first time, will be considered as new applications. In addition to the dossier submitted, the applicant is required to provide the following:

  1. Samples of the product: These samples should be in the commercial pack(s) from one batch, and batch certificates of analysis for the samples should adhere to the schedule defined by WAHO (check wahooas.org) or the specific NMRA.
  2. Certificate of Pharmaceutical Product (CPP): The applicant must include a CPP issued in accordance with the format approved by the World Health Organization (WHO). This certificate should be issued by the competent drug regulatory authority of the country of origin/manufacture and should be submitted in Module 1 of the Product Dossier (PD).
  • Site Master File: A site master file of the plant in which the product was manufactured should be submitted as part of Module 3 in the application.
  1. Pharmacovigilance Plan: For New Chemical Entities (NCEs) and innovator products, the applicant must submit a pharmacovigilance plan. This information should be included in Module 1.2.8 (Periodic Safety Update Reports – PSURs).

Applications for Renewal of Registration:

For the renewal of registration, applicants must initiate the process at least 3 months before the expiration of the existing registration. The renewal application should include the following documents:

  • Duly filled application form for the renewal of registration.
  • Batch Manufacturing Record (BMR): A BMR of an actual batch manufactured within a maximum of six months before the submission of the renewal application.
  • Periodic Safety Update Reports (PSUR): Submission of PSURs is required.
  • Proof of interchangeability for multisource (generics): Details as explained in Part 5 of the application.
  • Any other requirements: Compliance with additional requirements specified by WAHO or the NMRA.
  • Samples of the product: Submission of samples in the commercial pack(s) from one batch, along with batch certificates of analysis. The schedule for submitting samples should adhere to the guidelines defined by WAHO or the NMRA.
  • Site Master File: Inclusion of a site master file for the plant where the product was manufactured.

Application for Variation of a Registered Product:

Applications for a variation to a registered product should adhere to the following requirements:

  • Duly filled application form for the variation of registration.
  • Samples of the product reflecting the proposed variation.
  • Site Master File: If the variation involves or includes a change in the name, site, and/or address of the manufacturer, a Site Master File of the manufacturer should be provided.
  • Other documents: Submission of additional documents to support or justify the proposed variation. 

SUBMISSION OF APPLICATION

Applications for the registration of products seeking region-wide market authorization should be directed to the Director General of WAHO through the designated Coordinating National Medicines Regulatory Authority (NMRA) specified in the Expression of Interest (EOI), following the approved format. For products intended for marketing authorization in a specific country, the application should be submitted to the Head of the NMRA in that country.

APPLICATION FEES

Application fees must be paid for each submitted application and can be in the form of a Banker’s draft or through wire transfer to the account specified by the relevant NMRA or WAHO. Detailed information on fees is available in the fee form provided in Annex B.

  • Application Fee for Registration of a Pharmaceutical Product:
    • Imported into ECOWAS: US$
    • Fully manufactured in ECOWAS: US$
  • Application Fee for Renewal of Registration of a Pharmaceutical Product:
    • Imported into ECOWAS: US$
    • Fully manufactured in ECOWAS: US$
    • Application Fees for Variation of Registration: US$
    • Other fees including those for appeal, replacement of certificates, laboratory tests among others may be charged by various country MRAs as their legislation requires.

Receipt And Evaluation of Dossiers:

Applications, whether submitted to WAHO or NMRAs, must be accompanied by the appropriate application fees.

Evaluation Process:

WAHO and NMRAs will assign application numbers sequentially to received applications and evaluate them on a first-come, first-served (FIFO) basis. Priority will be given to products addressing priority public health diseases such as Malaria, HIV/AIDS, Tuberculosis, and other neglected tropical diseases. Special consideration will be given to products manufactured by companies operating in member countries of the ECOWAS region.

A committee of experts at the WAHO secretariat, comprising regulatory officials and other scientists from member countries, will be constituted. Where necessary, specialists may be consulted for professional opinions on various sections of the dossiers. At the country level, evaluation will be conducted by in-country evaluators following this guideline and Standard Operating Procedures for dossier evaluation.

Additional information may be requested during evaluation, and if no response is received within six months of the request, the application may be discontinued. For applications submitted to WAHO, laboratory analysis based on validated in-house, or pharmacopoeia methods provided by applicants shall be performed in accredited quality control laboratories according to approved Standard Operating Procedures (SOPs).

To verifying compliance with current Good Manufacturing Practice (cGMP), all applications shall be accompanied by a Site Master File. An inspection may be conducted by WAHO or the NMRA of the country where marketing authorization is sought. The report and recommendations of WAHO inspection teams shall be shared with NMRAs to avoid duplication. Decisions on registration will be based on the dossier evaluation report, quality control report, and inspection report on compliance with cGMP.

Timelines:

Complete applications for expedited registration (Locally manufactured and Priority Medicines only), Post-Approval Variation, and Renewal of registration will be processed within 90 working days of receiving the applications. Complete new applications will be processed within 12 months of receipt of the application. The applicant is required to provide any requested additional data within 6 months. In case additional time is required, a formal request must be submitted.

Withdrawal Of an Application:

When the applicant fails to submit written responses to queries within 6 months from the date of their issuance, it will be deemed that the applicant has withdrawn the application. If the queries are reissued for a second time and the applicant provides unsatisfactory responses, the product will be disqualified, and the application will be rejected. The applicant will be required to apply afresh.

Validity of Registration:

The registration of a pharmaceutical product at WAHO or by a country NMRA shall be valid for five (5) years unless otherwise suspended or revoked by the NMRA or withdrawn by the applicant.

Appeals:

Any person aggrieved by a decision regarding any application for marketing authorization of a pharmaceutical product may, within two (2) months from the date of notice of the decision, make written representations to WAHO or the appropriate NMRA and submit additional data to support the appeal. Documentation supporting the manufacturer’s request to appeal a regulatory decision is placed in Module 1.1.