Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Fermer ce répertoireANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Fermer ce répertoireA. IMPORTING COUNTRIES
Afficher le documentBenin
Afficher le documentCameroon
Afficher le documentCentral African Republic
Afficher le documentEcuador
Afficher le documentFiji
Afficher le documentJamaica
Afficher le documentKenya
Afficher le documentMalawi
Afficher le documentMalaysia
Afficher le documentMyanmar
Afficher le documentPapua New Guinea
Afficher le documentSri Lanka
Afficher le documentTanzania
Afficher le documentTunisia
Afficher le documentYemen
Ouvrir ce répertoire et afficher son contenuB. EXPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenuC. INTERNATIONAL SUPPLY AGENCIES
Afficher le documentBACK COVER
 

Cameroon

1. Population

11.9 million in 1991.

2. Pharmaceutical import and consumption

Data on pharmaceutical import for 1992 were not available during the assessment. Total estimated value of imports in 1991 was US$ 63 million, and all the drugs came from France.

Drug consumption in 1989 in the public and private sector amounted to US$ 3.6 and US$ 112 million respectively. The value of drug consumption of the NGOs during the same year was US$ 7.2 million. The public sector drug budget in 1989 was US$ 8 million.

3. Drug policy and essential drugs list

Cameroon has no written and approved national drug policy, however elements of a national drug policy such as drug registration, quality control, drug procurement and regulatory control are being implemented.

The country has an essential drugs list called Liste nationale des Médicaments essentiels utilisés dans les Formations sanitaires, developed in 1990. It is being used in the procurement of drugs for the public sector. The list contains 120 products.

4. Infrastructure and functioning

4.1 Regulation and registration

Legislation on drug regulation exists. The Law No. 90 035, promulgated in 1990, relates to the activities of the pharmacy profession. Amendment No. 007, dated 13 July 1981, has legislation for the licensing of pharmaceutical specialities. Guidelines for registration were developed in 1981 and registration started the same year.

The Pharmacy Department in the Ministry of Health is responsible for drug registration, inspection and drug legislation activities.

About 90% of the products were registered at the time of the assessment. The figure does not include drugs imported into the country illegally.

4.2 Public and private procurement

The Office of National Pharmaceutics (ONAPHARM) under the Ministry of Health procures and distributes drugs for the public sector. Drugs are procured by means of restricted tender. Importation by ONAPHARM stopped in 1992. Donors also supply in kind.

There are five private importers purchasing drugs direct from wholesalers abroad. In 1992, about 3000 products were procured by the private sector from wholesalers in France.

4.3 Quality control of drugs

The quality control laboratory of ONAPHARM is responsible for testing the quality of drugs.

In 1992, 32 samples of the most commonly used drugs were sent for quality control and about 90.6% passed the tests. There are no criteria set for the regular quality control of drugs. In general, samples are collected and sent for analysis after receipt and payment and testing is done locally by the National Quality Control Laboratory.

Drugs imported by private sector are not subjected to quality control and there is no system for health personnel to report complaints regarding drug quality.

4.4 Inspection

The Inspection Office of the Pharmacy Department inspects the different drug establishments in the country.

 


5. Operation of the WHO Certification Scheme

Cameroon signed the Scheme in 1982 and the responsible authority is the Pharmacy Department of the Ministry of Health located in Yaoundé. The WHO list of competent authorities was not available at the time of the mission.

Since 1992, receipt of a Certificate of a Pharmaceutical Product is indicated as a prerequisite for drug registration in the guidelines. Since the system only started in 1993, the elements used are not precisely known and there is no specific indication as to the type of certificates needed. Information on drugs registered is not communicated to customs officers, public and private importers, and others. Contact with competent authorities in exporting countries is made directly.

Observations:

• The Scheme is not used in drug procurement in the public and private sector nor in drug registration.

• Quality testing of pharmaceuticals is not adequate.

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