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
 

Benin

1. Population

5 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were US$ 18.96 million. Major countries of origin were France 95% and other European countries 5%.

The value of drug consumption in public sector and private sector in 1992 amounted to US$ 2.9 and US$ 24.864 million respectively. The public sector budget in 1992 was US$ 4 million. The contribution to the public sector budget from national resources and from external assistance was 65% and 35% respectively.

3. Drug policy and essential drugs list

There is a written national drug policy approved in 1991. The policy has provisions for regulatory control, drug registration, drug procurement and quality assurance. A plan known as the "National Pharmaceutical Plan: Priority plan for a three year period (1994-1996)”, was developed in March 1993 for the implementation of the drug policy. However, the plan was not being adhered to at the time of the visit.

The National Essential Drugs List for Benin was developed in December 1990 and it is being used for procurement in the public sector. It comprises 203 products.

4. Infrastructure and functioning

4.1 Regulation and registration

The Pharmacy and Laboratory Department of the Ministry of Health is responsible for the registration of drugs, surveillance of movement of hard drugs, control of establishments and maintenance of daily statistics and documents. There are several decrees and regulations enacted by the government between 1975 and 1988 to regulate drugs. Regulations for drug registration were promulgated and put into action on 27 January 1975. Regulations related to drug quality do not exist.

The Drug Registration Division of the Pharmacy Department is responsible for the registration of drugs, and all pharmaceutical products imported by the private sector were registered at the time of the mission. However, this does not take into consideration the significant number of illicit drugs available on the market.

4.2 Public and private procurement

The Central Medical Stores of Benin under the Ministry of Health procures and distributes drugs for the Public Sector. In addition, there are three wholesalers which import and distribute drugs for the private sector.

Procurement methods used for the public sector include: open and restricted tender; negotiated procurement; direct purchase from manufacturers/agents and international suppliers. The public sector also receives donations in kind.

In 1992, 26 products were procured from manufacturers in France and 60 were received from IDA and UNITRA.

Private sector importers purchase direct from wholesalers abroad. In 1992, 3500 products were procured by the private sector from wholesalers in France.

4.3 Inspection

The Inspection Division of the Pharmacy Department is responsible for the inspection of drug establishments.

4.4 Quality control of drugs

Benin has no drug quality control laboratory. In 1992, a total of five samples was sent by the Central Medical Stores to DHT Pharma Laboratory in France for quality control and all the samples passed. There are no clearly set criteria for regular quality control of drugs. In general, samples are collected and sent for analysis after receipt of drugs but before payment, and also after receipt and after payment. Drugs imported by the private sector are not tested and there is no system for health personnel to report complaints regarding drug quality.

5. Operation of the WHO Certification Scheme

Benin accepted the WHO Certification Scheme on 24 November 1982. The competent authority is Ministère de la Santé publique, Direction des Pharmacies, B.P. 2048 Cotonou. The WHO list of competent authorities was not available at the time of the mission.

Registration of drugs is carried out but the receipt of a Certificate of a Pharmaceutical Product as recommended by WHO is not formally laid down as a requirement for drug registration. Certificate of authorization for sale in the country of origin is requested for the registration of drugs. Competent authorities in exporting countries are contacted directly or through local agents, importers and manufacturers. Information on registered drugs is not communicated to customs authorities, public sector procurement authorities/retailers or others.

Request for a Certificate of a Pharmaceutical Product is not laid down in official procurement specifications. However, certificates of analysis are requested from manufacturers, wholesalers and international suppliers at the time of calling for tenders and at the time of placing orders. The certificates supplied do not correspond to the type of batch certificate recommended by WHO.

Observations:

• The Scheme is not used as recommended by WHO.
• Pharmaceuticals imported by the public sector are not registered.
• Quality testing of imported pharmaceuticals is not adequate.

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