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
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- 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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