Ministry of Health Mozambique's Medicine Registration- Mozambique National Medicines Control Authority (NMCA)

Regulatory Authority

Mozambique National Medicines Control Authority (NMCA) 

Local Authorized

Yes

Classification

Pharmaceuticals and Medical Devices

Registration Timeline

6-12 months

License Validity

5 Years

In Mozambique, the registration of medicines is governed by Law 4/98, enacted on 14th January, which establishes the legal framework for pharmaceutical practices. The registration of medicines is mandatory under this legal framework, and the specific regulations for registration are outlined in the Registration Regulation passed by Decree 22/99 on 4th May. Aligning with broader pharmaceutical product registration frameworks helps streamline compliance across national authorities.

Types of Registrations

1. Extraordinary Registration

This involves a simplified process for notifying medicines that already exist in the market and are distributed by licensed operators.

The registration is valid for 3 years, without the option for renewal or exclusivity.

2. Definite Registration

This is the normal registration process required for introducing medicines into the country.

The registration is valid for five years from the date of concession and may be renewed.

Pharmaceutical registration requirements vary across African markets, including South Sudan.

Definite Registration comprises Two Modalities

Simplified Registration

Involves the application for registration by acknowledging a registration granted in a country of reference.

Complete Registration

Requires the submission of all technical documentation necessary for registration when the Simplified Registration is not possible.  Standardized compilation often relies on expert CTD/eCTD dossier preparation.

Process of Registration

The application for registration can only be submitted by a registered company with a registered office in Mozambique.acting as a local marketing authorization holder or representative.

The application should specify

• Name of the medicine.
• Pharmaceutical form.
• Quantity and quality composition of active substances.
•  The application is to be hand-delivered upon making an appointment.
• The complexity and type of supporting documents (technical dossier) vary depending on whether it is a Complete or Simplified Registration.

Parts 1-A and 1-B: Summary of Process and Characteristics of Medicines

These parts are common to both modalities of definite registration (Simplified and Complete).

Part 1-A includes a summary of the registration process.

Part 1-B outlines the characteristics of the medicines under consideration for registration.

The process of registration involves compliance with the outlined legal framework, submission of the required documentation, and adherence to specific modalities based on whether it is an extraordinary or definite registration. This ensures that medicines meet the necessary standards and are authorized for introduction and sale within Mozambique.

Part 1-A: Summary of Process Administrative Information

1. Type of Process (Complete/Simplified)

Indicate whether the registration process is complete or simplified.

2. Proposed Name for Medicine

Provide the suggested name for the medicine under consideration.

3. Quantity and Quality Composition related to Active and Excipient Substance(s)

Specify the amounts and quality of both active and excipient substances in the medicine.

4. Pharmaceutical-Therapeutic Rankings

Outline the pharmaceutical-therapeutic rankings associated with the medicine.

5. Pharmaceutical Form and Dosage

Describe the specific pharmaceutical form and dosage of the medicine.

6. Presentation

Provide details on how the medicine is presented.

7. Validity Term/Storing Condition

Indicate the period of validity and the recommended storage conditions for the medicine.

8. Exemption Ranking

Specify any exemption ranking associated with the medicine.

9. Applicant’s Name and Address

Provide the name and address of the entity applying for the medicine registration.

10. Manufacturer of Finished Product

 Identify the manufacturer responsible for producing the finished medicine product, ensuring compliance verified through a GMP compliance audit. 

Part 1-B: Characteristics of Medicine

1. Summary of Characteristics of Medicines

Provide a comprehensive summary of the key characteristics of the medicine, including:

• Name of the medicine.
• Quantity and quality composition related to active substances.
• Pharmaceutical form and respective weight, volume, contents, or number of units.
• Validity term/storing condition.
• Therapeutic indications.
• Dosage and means of administration.
• Counter-indications.
• Medicinal interactions.
• Use in case of pregnancy and breastfeeding.
• Effects on the capacity to drive and use machines.
• Undesirable effects.
• Name of the holder of the registration of the medicine.

2. Label

Include the following information on the medicine label:

• Name of the medicine.
• Quantity and quality composition related to active substances per unit of taking, volume, or weight.
• Pharmaceutical form and respective weight, volume, contents, or number of units.
• Validity term.
• Registration number.
• Name of the holder of the registration.
• Exemption ranking.
• Conservation precautions, if applicable.
• The expression “External Use” printed in red, if applicable.

Part II – Chemical and Pharmaceutical Documentation

1 – Composition

• Quantity and quality composition, including components of coatings, capsules, etc.
• Description of primary and secondary packaging, potential interactions with the medicine, and control methods.
• Function of non-active constituents.

2 – Manufacturer

• Manufacturing formula.
• Description of preparation and control methods supported by pharmaceutical product testing data.

3 – Raw Materials

• Chemical description of active and excipient substances.
• Foreseeable impurities, specifications, and control methods.
• Manufacturer’s identification and analytical bulletin.

4 – Finished Product

• Specifications for global control.
• Specifications for active substance(s) control.
• Data on sterility and “pyrogens” (if applicable).
• Analytical bulletin of the finished product.

5 – Stability of Finished Product

• Duration, conditions, number, and size of lots studied.
• Tests conducted, including potential degradation products.

6 – Other Information (if applicable)

• Validation of analytical methods.
• Validation of manufacturing processes.
•  
• Other relevant information.

Part III – Documentation on Security

1 – Toxicity

• Summary description of medicine toxicity, including studies carried out and bibliographic references.

2 – Reproductive Function and Embryo-Fatal and Peri-Natal Toxicity

• Summary description of effects on reproductive function, embryo-fetal, and peri-natal toxicity, including studies and references.

3 – “Mutagenic” and Carcinogenic Potential

• Summary description of data on “mutagenic” and carcinogenic potential, including studies and references.

4 – Pharmacodynamics and Pharmacokinetics

• Summary description of mechanisms of action and pharmaco-kinetics, including studies and references.

5 – Other Data on Security

• Local tolerance.
• Environmental impact.
• Other relevant security data.

Part IV – Documentation on Effectiveness

1 – Clinical Pharmacology

• Summary description of therapeutic action mechanisms and pharmaco-kinetics, including studies and references.

2 – Clinical Experiment

• Summary description of clinical tests, available cautionary data, including studies and references.