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
 

Papua New Guinea

1. Population

2.4 million in 1992.

2. Pharmaceutical import and consumption

Pharmaceutical imports in 1992 amounted to US$ 15 million. Main exporting countries were: Australia 15%, Austria 10%, China 10%, Germany 10%, Hong Kong 5%, India 15%, Singapore 5% and UK 5%.

Drug consumption in 1992 in the public and private sector was US$ 13 and US$ 2.5 million respectively. The public sector drug budget for 1992 was US$ 12 million and the national contribution and the external assistance were 97% and 3% respectively.

3. National drug policy and essential drugs list

There is no written and approved national drug policy but some elements of a national drug policy are being practised.

The Medical Stores Catalogue, 7th edition formulated in 1988, is used for the procurement of drugs in the public sector. The catalogue is based on the WHO Model List of Essential Drugs and is revised by the Pharmacy Advisory Committee of the Department of Health. The list comprises 356 products.

4. Infrastructure and functioning

4.1 Drug regulation and registration

The Therapeutic Substances and Cosmetics Act of 1987 is the legal instrument for the regulation of drugs in the country. There is no drug registration system at present but its establishment is envisaged in the Act of 1987 and regulations necessary for its implementation are at the drafting stage.

4.2 Public and private drug procurement

There are two supply systems in the country. Public and religious health units are supplied by the government distribution system, the Pharmaceutical Supplies Office, under the Pharmaceutical Services of the Department of Health. Procurement by the office is done by means of open and restricted tender, negotiated procurement, and direct purchase from manufacturers and wholesalers. In 1992, 342 products were purchased from manufacturers located in Australia, Austria, China, Germany, Hong Kong, India, Singapore and UK. Drugs were also procured from wholesalers located abroad and locally during 1992.

In the private sector there are five wholesalers which purchase drugs from India, Malaysia and Singapore. Prescribing doctors buy drugs either locally or from abroad. Procurement in the private sector is done by means of negotiated procurement and direct purchase from manufacturers and wholesalers.

4.3 Quality control of drugs

Measures to assure the quality of imported drugs are undertaken only in respect of some products purchased through the public system. This includes requesting of a product certificate with tender documents. This pertains however to new suppliers only and in 1992 such certificates were obtained for only 3% of the products included in tenders. On delivery, products have to be accompanied by analytical certificates. No testing of drug samples is done at the moment although there are laboratory facilities at the University of Technology in Lae.

 


5. Operation of the WHO Certification Scheme

Papua New Guinea accepted the Scheme on 1 September 1982 and the designation and address of the competent authority is: Chief of Pharmaceutical Services, Department of Health, P.O. Box 84, Konedobu.

A Certificate of a Pharmaceutical Product is requested only in the public sector and it is enforced only in those cases when the supplier of a drug was not previously known to the procurement agency. It is generally waived in respect of well established international manufacturers. In case of small volume items, batch certificates are not requested. In the private sector, a Certificate of a Pharmaceutical Product and a batch certificate are not requested.

Observations:

• A Certificate of a Pharmaceutical Product is requested in the public sector.

• Import by the private sector is not controlled and a Certificate of a Pharmaceutical Product is not requested.

• There is no quality control testing done on imported drugs.

• In a few cases, designations on certificates differ from those indicated in the WHO list.

• Countries not listed in the WHO list and not signatory to the Scheme issue certificates.

• Batch certificates issued do not refer to the relevant Certificate of a Pharmaceutical Product.

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