Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) View the PDF document
Table of Contents
View the documentACKNOWLEDGMENTS
View the documentPREFACE
View the documentEXECUTIVE SUMMARY
Open this folder and view contents1. INTRODUCTION
View the document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
View the document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Open this folder and view contents4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Open this folder and view contents5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
View the document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Open this folder and view contents7. SUMMARY ANALYSIS
View the document8. CONCLUSIONS
View the documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
View the documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
View the documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
View the documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
View the documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
View the documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the documentANNEX 4 (b): Certificate of a Pharmaceutical Product
View the documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
View the documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
View the documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
View the documentANNEX 6: List of Participants in the Study
View the documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
View the documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
View the documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Close this folderANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Close this folderA. IMPORTING COUNTRIES
View the documentBenin
View the documentCameroon
View the documentCentral African Republic
View the documentEcuador
View the documentFiji
View the documentJamaica
View the documentKenya
View the documentMalawi
View the documentMalaysia
View the documentMyanmar
View the documentPapua New Guinea
View the documentSri Lanka
View the documentTanzania
View the documentTunisia
View the documentYemen
Open this folder and view contentsB. EXPORTING COUNTRIES
Open this folder and view contentsC. INTERNATIONAL SUPPLY AGENCIES
View the documentBACK 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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