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Mozambique
Drug Registration Requirements in Mozambique
Registration of Medicines in Mozambique

Heitor Rebeca Dos Santos

Official Translator Sworn in by the Court of Maputo City - Mozambique
Contact: Rua Rufmo de Oliveira, 73 Maputo. Tel: 00258-1-300210, Cell: 00258-82-484369

Ministry of Health
National Directorate of Health
Pharmaceutical Department

Registration of Medicines in Mozambique

- The Law 4/98, dated 14th January sets a new legal framework for the medicine and the exercise of pharmaceutical profession
- Within this new legal framework the REGISTRATION OF MEDICINES is compulsory in order that medicines can be introduced and sold within the Country.
- The REGISTRATION REGULATION was passed by Decree 22/99, dated 4th May.
WHAT TYPE OF REGISTRATIONS

Two types of registration of medicines are foreseen:
- EXTRAORDINARY - Simplified process of notifying medicines already existing within the market by licensed operators. This registration is valid for 3 years without being entitled to renewal or exclusivity.
- DEFINITE - Normal process of registration of medicines in order to obtain authority for the introduction of medicines. It is valid for five years as from the date of its concession and might be renewed.

The definite registration comprises two modalities: Complete and Simplified Registration:
- SIMPLIFIED - regards the application for registration by acknowledgement of one registration granted in a country of reference;
- COMPLETE - corresponds to the submission of all technical documentation required for registration when the Simplified Registration is not possible.

- The Law 4/98, dated 14th January sets a new legal framework for the medicine and the exercise of pharmaceutical profession - Within this new legal framework the REGISTRATION OF MEDICINES is compulsory in order that medicines can be introduced and sold within the Country. - The REGISTRATION REGULATION was passed by Decree 22/99, dated 4th May. WHAT TYPE OF REGISTRATIONS

- The application for registration might only be submitted by a registered company and having registered office in Mozambique,
- The application should specify:
- Name of medicine;
- Pharmaceutical form;
- Quantity and quality composition of active substances;
- Manufacturer.
- Application is always delivered to the right hand upon making an appointment
- Complexity and type of backing documents (technical dossier) varies on whether it is a Complete or Simplified Registration

Parts 1-A: Summary of Process and 1-B: Characteristics of Medicines - the two modalities of definite registration are common.

PROCESS OF REGISTRATION (TO BE IN PORTUGUESE & ENGLISH)
 
PART 1-A: SUMMARY OF PROCESS ADMINISTRATIVE INFORMATION

Type of process (complete/simplified)
- Proposed name for medicine
- Quantity and quality composition related to active and excipient substance(s)
- Pharmaceutical-therapeutic rankings Pharmaceutical form and dosage
- Presentation
- Validity term/storing condition
- Exemption ranking
- Applicant's name and address
- Manufacturer of finished product

PART 1-B: CHARACTERISTICS OF MEDICINE

1. SUMMARY OF CHARACTERISTICS OF MEDICINES
- Name of 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 over the capacity to drive and use machines
- Undesirable effects
- Name of holder of registration of medicine

2. LABEL
- Name of 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 holder of registration
- Exemption ranking

Particular conservation precautions, if that is the case
- The expression "External Use" printed in red, if that is the case

CONTENTS OF COMMON PARTS (TO BE IN PORTUGUESE AND ENGLISH)

PART II - CHEMICAL AND PHARMACEUTICAL DOCUMENTATION

A-l -Composition
- Quantity and quality composition, including components of eventual coatings, capsules, etc.
- Description of primary and secondary packaging, its possible interactions with the medicine and methods of control used
- Function of non-active constituents

A-2 - Manufacture
- Manufacturing formula
- Description of preparation and methods of control

A-3 - Raw Materials
- Chemical description of active and excipient substance
- Foreseeable impurities, specifications and method of control
- Manufacturer's identification and analytical bulletin

A-4 - Finished Product
- Specifications of global control
- Specifications of active substance(s) control
- Data on sterility and "pyrogens" (if applicable)
- Analytical bulletin of finished product

A-5 - Stability of Finished Product
- Duration of studies
- Conditions of studies
- Number and dimension of lots studied
- Tests made and limits, including eventual products of degradation

A-6 - Other Information (if applicable)
- Validation of analytical methods
- Validation of manufacturing processes
- Bio-availability
- Others

PART III - DOCUMENTATION ON SECURITY

A-1 - Toxicity
- Summary description of medicine toxicity, including summary of studies carried out, and bibliographic references, if available.

A-2 - Reproductive function and embryo-fetal and peri-natal toxicity
- Summary description of effects of medicine over the reproductive function, embryo-fetal and peri-natal toxicity, including summary of studies carried out, and bibliographic references, if available

A-3 - "Mutagenic" and Carcinogenic Potential
- Summary Description of data existing on the medicine "mutagenic" and carcinogenic potential, including summary of studies carried out, and bibliographic references, if available.

A-4 - "Pharmaco"-dyanmics and "Pharmaco"-Kinetics
- Summary description of mechanisms of action and of pharmaco-Kinetics of medicine, including summary of studies carried out, and bibliographic references, if available.

A-5 - Other data on security
- Local tolerance
- Environmental impact
- Other data

PART IV - DOCUMENTATION ON EFFECTIVENESS

A-1 - Clinical Pharmacology
- Summary description of mechanisms of therapeutic action and of pharmaco-kinetics of medicine, including summary of studies carried out, and bibliographic references, if available
A-2 - Clinical Experiment
- Summary description of clinical tests carried out on the medicine, as well as data of "pharmaco"-caution available, including summary of studies carried out. and bibliographic references, if available.

CONTENTS OF SPECIALITY: COMPLETE REGISTRATION (ENGLISH)

PART-II - CHEMICAL AND PHARMACEUTICAL DOCUMENTATION

B-1 - Composition
- Description of quantity and quality composition, including proportion salt/active substance, if that is the case, as well as components of eventual coatings, capsules, etc.
- Description of primary and secondary packaging, as regards material(s) used

B-2 - Manufacturing
- Manufacturing formula, including number of units of one lot

B-3 - Raw Materials
- Chemical description of active substance (nomenclature, molecular formula, identifying characteristics)

B-4 - Finished Product
- Analytical bulletin of finished product, indicating clearly specifications and limitations

B-5 - Stability of finished product
- Duration and conditions of studies carried out
- Proposed validity term, and conservation conditions

A-6 - Other Information (if applicable)
- Validation of analytical methods
- Validation of manufacturing processes
- Bio-availability
- Others

PART III - DOCUMENTATION ON SECURITY

A-1 - Toxicity
- Summary description of medicine toxicity, including summary of studies carried out, and bibliographic references, if available.

A-2 - Reproductive function and embryo-fetal and peri-natal toxicity
- Summary description of effects of medicine over the reproductive function, embryo-fetal and peri-natal toxicity, including summary of studies carried out, and bibliographic references, if available

A-3 - "Mutagenic" and Carcinogenic Potential
- Summary Description of data existing on the medicine "mutagenic" and carcinogenic potential, including summary of studies carried out, and bibliographic references, if available.

A-4 - "Pharmaco"-dyanmics and "Pharmaco"-Kinetics
- Summary description of mechanisms of action and of pharmaco-Kinetics of medicine, including summary of studies carried out, and bibliographic references, if available.

A-5 - Other data on security
- Local tolerance
- Environmental impact
- Other data

PART IV - DOCUMENTATION ON EFFECTIVENESS

A-1 - Clinical Pharmacology
- Summary description of mechanisms of therapeutic action and of pharmaco-kinetics of medicine, including summary of studies carried out, and bibliographic references, if available

A-2 - Clinical Experiment
- Summary description of clinical tests carried out on the medicine, as well as data of "pharmaco"-caution available, including summary of studies carried out. and bibliographic references, if available.

CONTENT OF SPECIALITY (ENGLISH)

PART-II - CHEMICAL AND PHARMACEUTICAL DOCUMENTATION

B-1 - Composition
- Description of quantity and quality composition, including proportion salt/active substance, if that is the case, as well as components of eventual coatings, capsules, etc.
- Description of primary and secondary packaging, as regards material(s) used

B-2 - Manufacturing
- Manufacturing formula, including number of units of one lot

B-3 - Raw Materials
- Chemical description of active substance (nomenclature, molecular formula, identifying characteristics)

B-4 - Finished Product
- Analytical bulletin of finished product, indicating clearly specifications and limitations

B-5 - Stability of finished product
- Duration and conditions of studies carried out
- Proposed validity term, and conservation condition

PART III - DOCUMENTATION ON SECURITY

Presentation of a summary on product security, including at least one bibliographic reference within a publication of international top credibility.

PART IV - DOCUMENTATION ON EFFECTIVENESS

Presentation of a summary on product effectiveness, including at least one bibliographic reference within a publication of international top credibility.

For further information contact:
Technical Commission of Registration of Medicines
Pharmaceutical Department
Ministry of Health

Corner of Avenida Eduardo Mondlane & Avenida Salvador Allenda
Maputo (Mozambique) Phone: 00258-1-426554-7, Telefax: 00258-1-300473

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