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
 

Fiji

1. Population

750,000 in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 5 million and the major countries of origin were: Austria, Germany, Hong Kong, India, Malaysia, Singapore and UK.

Drug consumption in the public and private sector during the year amounted to US$ 48 and US$ 3 million respectively. The value of drug consumption of the NGOs in 1992 was US$ 2 million. The total public sector drug budget in 1992 was US$ 3.4 million and the contributions from national and external sources were 90% and 10% respectively.

3. Drug policy and essential drugs list

Fiji has no written and approved national drug policy but elements of a national drug policy such as drug procurement and drug selection are being implemented.

There is an official essential drugs list called Drug List of the Government Pharmacy, developed in 1991. The list contains 300 products and is used for procurement of drugs in the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

The Pharmacy and Poisons Act of 1938 (amended in 1983) is the legal instrument used in the control of drugs in Fiji. There are no regulations related to drug registration or drug quality. The Pharmacy and Poisons Board is responsible for the licensing of pharmacies.

There is no drug registration as such but establishment of a registration system is envisaged although no decision has been taken.

4.2 Public and private procurement

Procurement of drugs in the public sector is carried out by open tender by the Government Pharmacy which operates on a separate arrangement under the National Drug Bulk Purchasing Scheme and by means of direct purchase from manufacturers and wholesalers through Crown Agents in UK. In 1992, a total of 400 products was procured and the countries of manufacture were Austria, Germany, Singapore and UK. Also, drugs were bought from wholesalers in New Zealand and UK.

Procurement for the private sector is done by three large drug wholesalers and about 20 retail pharmacies. The private sector covers 30% of the national demand.

4.3 Quality control of drugs

There is no laboratory service. In 1992, five samples of products were sent for quality testing to the University of South Pacific, Suva. Samples are usually sent for testing after receipt and after payment, and following complaint.

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

There is no inspection service.

 


5. Operation of the WHO Certification Scheme

Fiji accepted the Scheme on 30 December 1980 and the responsible authority is the Chief Pharmacist, Government Pharmacy, P.O. Box 106, Suva. The name and address of the competent authority is included in the last issue of the WHO Secretariat list.

Certificate of a Pharmaceutical Product and batch analytical certificates are requested for each product submitted for tender in the public sector. The documents are requested from manufacturers or their agents at the time of calling for tenders. Guidelines on how to obtain these documents are given to importers. In practice, the requirement is applied especially when the supplier is providing a given product for the first time. A batch certificate is not required in the case of products purchased by Crown Agents. In 1992, Certificates of a Pharmaceutical Product were obtained for 15% of the products included in the tender. The Scheme is not used in the private sector.

Observations:

• There is no drug registration system.

• The Scheme is applied partially to drugs imported by the public sector.

• No regulatory control over drugs imported by the private sector.

• No quality testing done on drugs received through the private sector.

• Batch analytical certificates received from manufacturers do not refer to the relevant Certificate of a Pharmaceutical Product as recommended by WHO.

• Sometimes, designations of authorities on certificates differ from those given in the WHO list.

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