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
 

Tanzania

1. Population

19 million in 1992.

2. Pharmaceutical import and consumption

Pharmaceuticals valued US$ 38.2 million were imported into the country in 1992. Main exporting countries were: Belgium, Denmark, Germany, Italy, Kenya, the Netherlands, Switzerland and UK.

Drug consumption during the same year in the public sector was US$ 11.5 million. The total public sector drug budget in 1992 was US$ 7.1 million.

3. Drug policy and essential drugs list

A national drug policy called "Tanzanian National Drug Policy" was written and approved in 1991. The policy covers all aspects relating to drug regulatory control, drug registration, drug procurement and quality assurance. There is a plan "The Master plan for the Pharmaceutical Sector, 1992-2000, Tanzania, Mainland” developed in 1991. The country is in the process of implementing the policy.

The Tanzanian Standard Treatment Guidelines and the National Essential Drugs List were first formulated in 1981 and revised in 1993. The list is used for procurement of drugs in the public sector and comprises 290 products.

4. Infrastructure and functioning

4.1 Drug regulation and registration

The Pharmaceutical and Poisons Act No 9 of 1978 is the legal instrument for the regulation of drugs in Tanzania. Regulations made under section 71 of the Pharmaceutical and Poisons Act of 1978 were passed in 1990. Based on these regulations, guidelines for notification and process are to be developed in due course.

The Pharmacy and Poisons Board established by the Ministry of Health is responsible for the issuance of licenses to manufacturers, wholesalers, and retail outlets. It also evaluates and registers drugs and regulates the activities of pharmacy professionals. Drug registration is envisaged to start in 1995.

4.2 Public and private procurement

There are three main drug supply channels in Tanzania. The public health units receive drugs from the Central Medical Stores under the Ministry of Health. The National Pharmaceutical Company (NAPCO), a parastatal organization under the Ministry of Trade, imports and distributes drugs to private sector and parastatal health institutions. There are 35 licensed private importers.

Procurement in the public sector is by means of open tender and on special occasions through restricted tender. Specialized products are purchased direct from manufacturers. Drugs are also purchased directly from international suppliers or received as donations in kind. In 1992, 104 products were procured from manufacturers in Belgium, Denmark, Germany, Italy, Kenya, Switzerland and UK and eight products from wholesalers in Germany and UK by the CMS. In the private sector drugs are procured directly from manufacturers and wholesalers.

4.3 Quality control of drugs

The Government Chemist under the Ministry of Health and the laboratory at the Central Medical Stores carry out quality control tests on drugs. Drugs imported by the CMS are rarely tested for quality. In most cases, quality assurance is limited to visual inspection by the CMS staff. In the private sector drugs are sometimes tested by the regulatory authorities. In 1992, a total of 175 samples of products were tested by the Government Chemist Laboratory of which 122 passed, 49 failed and four could not be analyzed due to lack of reagents.

 


5. Operation of the WHO Certification Scheme

The Scheme was accepted by Tanzania on 27 June 1978 and the responsible authority is the Ministry of Health, P.O. Box 9083, Dar es Salaam. The address and designations of the competent authority are included in the last issue of the WHO Secretariat list.

The receipt of a Certificate of a Pharmaceutical Product is a requirement for registration of drugs and the requirement is indicated in application forms for notification.

The Central Medical Stores tender document calls for the submission of GMP certificate and Licensing Status Certificate at the time of calling for tenders. Bidders with GMP and Free Sale certificates are given preference by the Tender Technical Committee. Products from manufacturers are sometimes accompanied by batch certificates, while products from agents and wholesalers arrive without batch certificates.

Contact with competent authorities in the exporting countries is made directly.

Observations:

• The WHO Certification Scheme is not operational.

• There is no drug registration.

• There is no control over drugs imported by the private sector.

• In the public sector GMP and Free Sale certificates are requested.

• A Batch certificate is not required for imported drugs.

• Sometimes, dubious certificates are submitted together with bids which the CMS is unable to reject due to lack of the WHO list of competent authorities.

• The quality assurance system is not adequate.

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