Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoACKNOWLEDGMENTS
Ver el documentoPREFACE
Ver el documentoEXECUTIVE SUMMARY
Abrir esta carpeta y ver su contenido1. INTRODUCTION
Ver el documento2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Ver el documento3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Abrir esta carpeta y ver su contenido4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Abrir esta carpeta y ver su contenido5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Ver el documento6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Abrir esta carpeta y ver su contenido7. SUMMARY ANALYSIS
Ver el documento8. CONCLUSIONS
Ver el documentoANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Ver el documentoANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Ver el documentoANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Ver el documentoANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Ver el documentoANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Ver el documentoANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Ver el documentoANNEX 4 (b): Certificate of a Pharmaceutical Product
Ver el documentoANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Ver el documentoANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Ver el documentoANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Ver el documentoANNEX 6: List of Participants in the Study
Ver el documentoANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Ver el documentoANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Ver el documentoANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Cerrar esta carpetaANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Cerrar esta carpetaA. IMPORTING COUNTRIES
Ver el documentoBenin
Ver el documentoCameroon
Ver el documentoCentral African Republic
Ver el documentoEcuador
Ver el documentoFiji
Ver el documentoJamaica
Ver el documentoKenya
Ver el documentoMalawi
Ver el documentoMalaysia
Ver el documentoMyanmar
Ver el documentoPapua New Guinea
Ver el documentoSri Lanka
Ver el documentoTanzania
Ver el documentoTunisia
Ver el documentoYemen
Abrir esta carpeta y ver su contenidoB. EXPORTING COUNTRIES
Abrir esta carpeta y ver su contenidoC. INTERNATIONAL SUPPLY AGENCIES
Ver el documentoBACK COVER
 

Central African Republic

1. Population

3 million in 1992.

2. Pharmaceutical import and consumption

Total pharmaceutical imports in 1992 were estimated at US$ 16.3 million and the major countries of origin and the respective shares from the total imports were: Denmark 5%, France 90% and Switzerland 5%.

Drug consumption in the public and private sector during the year amounted to US$ 1.246 and US$ 9.052 million respectively. The value of drug consumption of the NGOs in 1992 was US$ 0.016 million. The total public sector drug budget in 1992 was US$ 1.72 million and the contributions from national and external sources were 33% and 67% respectively.

3. Drug policy and essential drugs list

There is no written and approved national drug policy but elements of a national drug policy such as procurement and inspection are being implemented. There is an essential drugs list developed in 1992 but it is not yet official. The list contains 203 products and is being used for procurement of drugs for the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

There was no drug regulatory authority nor drug legislation at the time of the mission. Only draft regulations for registration existed.

4.2 Public and private procurement

The Central Medical Stores, under the Direction générale de la Santé publique (General Direction of Public Health) of the Ministry of Health, procures and distributes drugs for the public sector.

Drugs are procured in the public sector directly from manufacturers/agents and wholesalers abroad and in the country. There is also donors' supply in kind. In 1992, about 10 products were bought from manufacturers and their agents in France.

There are three wholesalers importing and distributing drugs to 25 pharmacies. They buy drugs directly from manufacturers/agents and wholesalers abroad. In 1992, about 3000 products were procured from manufacturers and wholesalers in France.

4.3 Quality control of drugs

There is no drug quality control laboratory in the country. Drugs imported are not tested to ensure their quality and there is no system for health personnel to report complaints regarding drug quality.

4.4 Inspection

The Pharmaceutical Inspection Service of the MOH inspects drug establishments in the country.

 


5. Operation of the WHO Certification Scheme

The Central African Republic accepted the Scheme on 22 July 1980 and the responsible authority is the Pharmacy Inspection Service of the MOH in Bangui. The WHO list of competent authorities was available at the time of the mission.

Observations:

• The Scheme is not being used.
• A drug regulatory authority does not exist.

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