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Madagascar Drug Product Registration

Ministry of Public Health Regulatory Procedures for Medicines Approval in Madagascar

Regulatory Authority

Ministry of Public Health

Link for Regulatory Authority 

http://www.sante.gov.mg/ministere-sante-publique/

Local Authorised 

Yes

Classification of Medical Devices

Traditional Medicines, Cosmetics in Madagascar

Registration Timeline

6-12 months

Registration Fee

Not Mention

License Validity 

5 Years

Registration of Finished Goods and Products TM/MC Assimiles

  1. DEFINITIONS
  1. a) MT/MC Products Include

Medicinal plants: These are accessory forest products used in medicine and the preparation of pharmaceutical or chemical products. Herbaceous plants (Drosera, Centella, Catharanthus, etc.), woody plants (Rauwolfia, Pygeum, Hazunta, Harungana, etc.), and medicinal plants of aquatic origin (Spirulina, red or brown algae or others). Note that the list of plants or parts of plants classified as narcotics is established by Order No. -14,571/2013 of July 5, 2013.

Finished TM/MC products: Preparations obtained from one or more plants containing active constituents from parts of plants or other organic or inorganic materials (animal or mineral materials) or a combination of both. Products may contain excipients. However, if chemically defined active ingredients are combined, these products are no longer considered plant-based medicines.

Semi-finished products or similar products: Substances or mixtures of substances that have undergone transformation treatments.

b). Different types of Finished MT/MC Products

Traditional Remedies

Substances of plant, animal, or mineral origin presented as promoting the prevention or treatment of human diseases, traditionally used on socio-cultural and/or religious foundations. They are not intended for parenteral injection.

Improved traditional remedies (RTA)

Herbal remedies modified to increase acceptability, labeled with active ingredients originating exclusively from plants.

Cosmetic and personal hygiene products 

Contain active ingredients from plants or other non-plant materials (animal and mineral materials) or a combination, intended for contact with the superficial parts of the human body.

Insecticides and acaricides 

Contain active ingredients from plants or other non-plant materials, intended to be applied to humans.

Dietetic products 

Contain active ingredients from plants or other non-plant materials, intended for a specific diet, distinguished from commonly consumed foodstuffs.

AMM

Marketing Authorization, an authorization issued by the Ministry of Health before marketing health products.

Officinal Preparation

Medication prepared in a pharmacy according to pharmacopoeia indications or a recognized form, dispensed directly to patients.

Master Preparation 

Medication prepared extemporaneously in a pharmacy or health establishment based on a prescription for a specific patient.

Preparations intended for the conduct of therapeutic trials

Drugs subjected to preclinical studies with conclusive in vivo or in vitro results on an animal model, indicating the absence of drug toxicity. 

New Request for Marketing Authorization

Finished TM/MC products of any category must adhere to national ethical standards, the ethical standards of the Malagasy pharmacopoeia, or other pharmacopoeias recognized by the Malagasy State. Before public sale, finished TM/MC products of any category require a Marketing Authorization (AMM) issued by the Madagascar Medicines Agency of the Ministry of Health for a five-year period.

Medicinal preparations, compounded preparations, and preparations intended for the conduct of therapeutic trials are exempt from Marketing Authorization.

List of Documents to Be Submitted

For Category 1 TM/MC finished products

The MA application addressed to the Director of the DPLMT must include:

  • The identity or company name of the inventor or promoter.
  • The commercial name of the product.
  • The galenic form.
  • The method and routes of administration.
  • The content of the sales model.
  • The proposed therapeutic uses.
  • The wholesale price excluding tax.
  • The category of the medicine.
  • The planned distribution method.

Administrative Files

  • Certified photocopy of the authorization to open a health establishment manufacturing finished MT/MC products.
  • Inspection report established by the MSANP or BPF.
  • Photocopy of the receipt for payment of the registration fee.
  • Letter of commitment on the veracity of the files provided by the MA holder, including a handwritten signature.
  • Letter of appointment of the official representative in Madagascar with his contact details if it is a foreign product.
  • Certified copy of the original of the Marketing Authorization issued by the competent authorities of the country of origin or, where applicable, the country of provenance or the certificate of free sale.
  • Certificate issued by the competent authorities certifying that the medicine is marketed in the country of origin or, where applicable, the country of provenance if it is a foreign product.
  • List of countries where the medicine is authorized and marketed, with attached copies of the Marketing Authorization if the product is foreign.

Technical files

  • Summary of Product Characteristics (SPC).
  • Sufficiently detailed document of the procedure for carrying out Thin Layer Chromatography (TLC) of the finished product and each component with results to allow their full reproduction.
  • Result of the microbiological sterility test with microbial limits.
  • Manufacturing procedures document: formula – process – control. All procedures must be validated and include a handwritten signature of the production manager.
  • Monograph (for each plant making up the finished TM/MC product) including botany, ethno-medical uses, and references.
  • Certificate of origin of active raw materials issued by the competent authority.
  • Six (06) samples of the finished product from the same batch, accompanied by the bulletin analysis of the corresponding batch duly completed and signed.
  • Samples of active raw materials from the same batch, accompanied by the analysis bulletins.
  • Instructions for use must be in legible characters allowing easy reading and published in print version. 

Renewal of Marketing Authorization (AMM) For Finished Products and Assimilar Products of Tm/Mc

The Marketing Authorization must be renewed six (06) months before its expiry date.

LIST OF DOCUMENTS TO BE SUBMITTED

The application file for the renewal of the registration of finished products and assimilated products of MT/MC must include the following documents:

A letter requesting renewal of the Marketing Authorization 

Addressed to the Director of Pharmacy, Laboratories, and Traditional Medicine specifying that no modification has been made to the elements produced in support of the request apart from the authorized modifications. This letter must include:

  • The identity or company name of the inventor or promoter.
  • The commercial name of the product.
  • The galenic form.
  • The method and routes of administration.
  • The content of the sales model.
  • The proposed therapeutic uses.
  • The wholesale price excluding tax.
  • The planned distribution method.

Administrative files

  • Former Marketing Authorization decision issued by AGMED.
  • Certified photocopy of the Good Manufacturing Practices certificate from the laboratory established by the competent health authority of the country whose validity dates back more than 6 months from the date of submission of the file (categories 2 and 3).
  • A photocopy of the renewal fee payment.
  • A certificate from the responsible pharmacist or the manufacturing manager specifying that no modification has been made to the elements produced.

Technical files

  • Summary of product characteristics.
  • Document of the procedure for carrying out thin-layer chromatography (TLC) or HPLC of the finished product and each component with results.
  • Result of the stability test delivered by a laboratory approved by the Ministry of Public health.
  • Result of microbiological sterility test with microbial limits.
  • Procedure document for carrying out gas chromatography (CPG) of the finished product and each constituent essential oil with results (categories 2 and 3).
  • Six (06) samples of the finished product presented in the packaging method of the sales model of the same batch, accompanied by the analysis report of the corresponding batch duly completed and signed.
  • Instructions for use must be in legible characters allowing easy reading and published in print version.

PROCEDURES TO FOLLOW

  • Submission of the MA Renewal Application File to the SPMT:
    • The manufacturer submits the Marketing Authorization (MA) renewal application file to the SPMT.
  • Payment of the Registration Fee with AGMED:
    • The manufacturer proceeds with the payment of the registration fee with AGMED.
  • Study/Verification of the File by the SPMT:
    • The SPMT conducts a thorough study and verification of the submitted file.
  • Sending the File to the LCQ for an Estimated Quote:
    • Upon completion of SPMT review, the file is sent to the LCQ for an estimated quote.
  • Payment of LCQ Acts by the Manufacturer:
    • The manufacturer makes the necessary payment for the acts carried out by the LCQ.
  • Product Quality Control with LCQ (Four Months):
    • The LCQ conducts a comprehensive product quality control, a process that takes four months.
  • File Evaluation Meeting by the CPT:
    • The CPT conducts a file evaluation meeting based on the number of files received.
  • Delivery of the Result of the Request:
    • The result of the renewal request is delivered six (6) months after its submission. The duration of the request for additional information is not included in this period. 

Request for Modification of AMM or Types of Variation

Any modification made to one or more elements of the finished product, excluding the price, must be the subject of a new application for the registration of the Marketing Authorization. Variations in the Marketing Authorization may concern the following elements:

  • Modification of the composition of active ingredients and/or excipients and/or the process of manufacturing.
  • Modification or updating of therapeutic indications.
  • Changes in raw material and/or finished product specifications.
  • Updating summaries of product characteristics.
  • Modification of the duration and/or conditions of storage.
  • Stoppage and resumption of drug marketing.

In the case of the first five modifications, six (06) samples of the finished product, presented in the packaging method of the sales model of the same batch, must be attached, accompanied by the analysis report of the corresponding batch duly completed and signed.

The following modifications must be justified:

  • Change or addition of an alternative manufacturing site.
  • Transfer of MA holder with the reason for modification by the former holder and agreement of both parties.
  • Modification of primary and secondary packaging.
  • Extension of the range.
  • Modification of analysis methods.
  • Changed batch size.

The Summary of Product Characteristics (RCP), The Instructions and the Label

The Summary of Product Characteristics (SPC)

It must include the following sections:

  • Commercial name of the product.
  • Pharmaceutical form.
  • Content of sales models.
  • Qualitative composition and quantitative composition of active ingredients and excipients, highlighting the presence of excipients with a known effect.
  • Pharmacological properties.
  • Proposed therapeutic uses.
  • Method and route of administration. 
  • Precautions for use and warnings.
  • Interactions with other medications.
  • Uses in pregnancy and breastfeeding.
  • Side effects.
  • What to do in the event of an overdose.
  • Storage conditions.
  • Batch number 
  • Date of manufacture.
  • Expiration date.
  • The wholesale price excluding tax.
  • Name and address of the manufacturer.
  • The MA holder and/or operator.
  • Method of distribution envisaged.

The notice must mention the following information

  • Commercial name of the product.
  • Pharmaceutical form.
  • Content of sales models.
  • Qualitative composition and quantitative composition of active ingredients and excipients, highlighting the presence of excipients with a known effect.
  • Pharmacological properties.
  • Proposed therapeutic uses.
  • Dosage, method, and route of administration.
  •  Precautions for use and warnings.
  • Interactions with other medications.
  • Uses in pregnancy and breastfeeding.
  • Side effects.
  • What to do in the event of an overdose.
  • Storage conditions.
  • Batch number.
  • Date of manufacture.
  • Expiration date.
  • Address of the MA holder, operator, and manufacturer.

The label must contain the following information

  • Commercial name of the product.
  • Pharmaceutical form.
  • Sales model capacity.
  • Qualitative and quantitative composition of active ingredients and excipients.
  • Dosage, instructions for use.
  • Proposed therapeutic indications.
  •  Precautions for use and warnings.
  • Manufacturer name.
  • Name of the MA holder and/or operator.
  • Batch number assigned by the manufacturer.
  • Readable and clear manufacturing dates and expiry dates. 

Madagascar List of files to be provided for the Registration of Drugs

List of files to be provided for the Registration of Drugs

New Application for Marketing Authorization (MA)

  • Application letter for MA to the Director of Madagascar Drug’s Agency
  • Summary of Product Characteristics (SPC)
  • Leaflet
  • Administrative files
  • Pharmaceutical, analytical and biological files Clinical, pharmacological and toxicological files (For new active ingredients and new combinations of active ingredients…)
  • Pharmacovigilance files
  • Appointment letter of the official representative in Madagascar with its coordinates
  • Samples

Application for Marketing Authorization (MA) Renewal

The renewal application for marketing authorization must include the following:

  • An application letter addressed to the Director of the Madagascar Drug’s Agency (refer to – 1), confirming that no changes have been made to the components submitted during the initial granting of MA.
  • A certified true copy of the currently valid Good Manufacturing Practices (GMP) certificate.
  • Summary of Product Characteristics (SPC).
  • The distribution and supply circuit recommended by the laboratory for the drug.
  • For specialties and brand generics listed in the VIDAL and Dorosz of the current year and/or manufactured by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) countries: Three samples from the same batch along with their certificate of analysis.
  • For generic drugs, the method of analysis and validation of control methods in the case of in-house methods, and samples from the same batch with their certificate of analysis (quantities required to perform all analyses specified by the monograph of the pharmacopoeia of the corresponding product reference).

Application for Marketing Authorization Modification

Any modification of one or more elements of the MA dossier of the drug must be subjected to assessment by Madagascar Drug’s Agency.

The Marketing Authorization modification may cover the following:

  1. Excipients composition manufacturing process
  2. Primary packaging nature
  • Brand name
  1. Summary of Product Characteristics and leaflet
  2. Packaging design
  3. Manufacturing site
  • Manufacturer’s name
  • MAH
  1. Content
  2. Duration and/or storage conditions
  3. Raw materials specifications
  • Analytical methods

Interruption or Cancellation of Marketing Authorization

  • Marketing Authorization Interruption: A letter of application for marketing authorization interruption should be addressed to the Director of the Madagascar Drug’s Agency.
  • Recovery of marketing is permitted if the marketing authorization is valid and/or the competent authority notifies the resumption of marketing following the revaluation of the benefit/risk of the product, which is subjected to batch recall.
  • Cancellation of Marketing Authorization Following the Manufacturer’s Request:

Pharmaceutical Products Import

  • Preferably, the first batch of imported products must match the batch of marketing authorization application samples.
  • To ensure the quality and traceability of pharmaceutical products distributed in Madagascar, each laboratory must inform the Madagascar Drug’s Agency and the distribution networks about the supply and distribution of its products. Any product imported that does not adhere to the required circuits specified by the concerned laboratory will be prohibited from sale.

Notes

Reassessment of Registration Files

  • All registration files that have been refused may undergo reassessment upon resubmission of a modified file.
  • The re-application of a refused file is contingent upon the payment of registration fees.

Validity of Pending Files

  • The validity of a pending file requiring additional information is three (03) months from the date of the claiming letter.
  • If the time limit is exceeded or after three (03) claims, the Madagascar Drug’s Agency will issue an unfavorable opinion and cease consideration of the case.

Refusal Causes

  • Causes of refusal are maintained for non-modified re-application files.

Ownership of Assessed Files:

  • Assessed files are the property of the Madagascar Drug’s Agency and cannot be returned to applicants.

Application Acceptance Limit:

  • Applications will no longer be accepted after two unfavorable decisions.

Deadline Extensions:

  • The first deadline for supplementary information may be extended upon the applicant’s request. The maximum extension period is 12 months from the date of the first claiming.
  • Second and third claiming deadlines cannot be extended.

Validity of Registration File

  • New MA: four (04) months from the receipt date of the bank credit payment notice.
  • Renewal of MA: two (02) months from the receipt date of the bank credit payment notice.
  • Variation of MA: two (02) months from the submission date of applications.

Types of Registration Fee

Registration Fee for new product

  • Annual Fee for all products having a valid MA
  • Renewal Fee.

Terms and Conditions of Payment:

  • Payment of fees must be strictly made within the period mentioned in the invoice, which is “three (03) months.”
  • No payment should be made before the submission of the file and the issuance of the final invoice.
  • Full or partial refunds of the paid fee are not provided, even if the request is denied, as these rights cover the cost of investigating the file.
  • All bank charges for transfers are the responsibility of the laboratory.
  • Any direct payments to the bank accounts of the Medicines Agency in Madagascar must be promptly notified to the accounting department of the Madagascar Drug’s Agency. (Enclosure: Original credit slip or a copy of the Swift Transfer with the reference of paid fees).

Categorization of Drugs for Registration

  • Category 1: Comfort specialty, vitamins, phyto-medicines, and dietary.
  • Category 2: Innovative product (under license).
  • Category 3: Branded generics specialty and essential public health specialty.
  • Category 4: Generic and drugs manufactured locally.

Laboratory Visit

As part of the verification of the implementation of Good Manufacturing Practices (GMP), pharmaceutical industries are required to facilitate access to their manufacturing facilities for representatives of the Madagascar Drug’s Agency.

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