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
 

Malawi

1. Population

8 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 9 million. The major areas/ countries of origin and the respective shares from the total imports were: Canada 3%, Cyprus 4%, Germany 30%, India 8%, Netherlands 7%, PTA 6%, South Africa 20% and UK 22%.

Drug consumption in the public and private sector during the year amounted to US$ 5.7 and US$ 3.3 million respectively. The total public sector drug budget in 1992 was US$ 5.7 million and the contribution of national and external sources were 53% and 47% respectively.

3. Drug policy and essential drugs list

Malawi has a written and approved national drug policy developed in 1991. It covers all aspects related to drug regulatory control, drug registration, drug procurement, and quality assurance. A plan called National Pharmaceutical Plan, 1990-1995, dated 1991, exists and is in the process of being implemented.

There is an official essential drugs list, the Malawi Essential Drugs List, developed in 1991. The list contains 311 products and is being used for procurement of drugs for the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

The Pharmacy, Medicines and Poisons Act, 1978 and the Pharmacy, Medicines and Poisons (Fees and Forms) Regulations 1990, empower the Pharmacy, Medicines and Poisons Board established by the Ministry of Health to regulate, register, and control the quality of drugs in Malawi. The Board is also responsible for the registration, ethical control and training of pharmacy professionals. The Board has a Medicines Committee for scheduling and registration of drugs.

Drug registration has not been introduced and there is no unit responsible for this within the Pharmacy Administration of the Ministry of Health.*

 

* Drug registration, quality control testing and inspection service were introduced after the assessment.

 

4.2 Public and private procurement

The Central Medical Stores, which comes under the supervision of the Controller of Health, Technical Services of the Ministry of Health, is responsible for procurement of drugs in the public sector. Procurement in the public sector is done by means of open tender and direct purchase from wholesalers abroad and in the country. There is also donors' supply in kind.

In 1992, about 80 products were bought from manufacturers in Canada, Cyprus, Germany, India, Kenya, South Africa and UK. Also, a total of 115 products was purchased from wholesalers in Germany, South Africa, the Netherlands and UK. UNICEF and the Canadian International Development Agency (CIDA) also made donations in kind. There was no quality control test done on the drugs purchased or donated.

In the private sector there are six wholesalers importing drugs through negotiated procurement and direct purchase from manufacturers and wholesalers. There is no control over private sector.

4.3 Drug quality control

There is no laboratory service and drugs received are not tested for their quality.*

4.4 Inspection service

There is no unit within the Pharmacy Administration responsible for inspection; as a result there is no inspection of drug establishments as such.*

* Drug registration, quality control testing and inspection service were introduced after the assessment.

 

5. Operation of the WHO Certification Scheme

Malawi signed the Scheme on 13 July 1982 and the responsible authority is the Ministry of Health, P.O. Box 30377, Lilongwe 3. The name and address of the competent authority is included in the last issue of the WHO Secretariat list.

The Scheme is not used either in drug procurement or in drug registration. However, a certificate of analysis is requested during procurement in the public sector.

Observations:

• The Scheme is not used.
• Registration of drugs has not commenced.
• Quality control testing of drugs does not exist.

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