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
 

Yemen

1. Population

14 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were US$ 68.64 million. Main suppliers were: Egypt 10%, Germany 9%, Jordan 12%, South Korea 4%, Switzerland 9%, UK 10%; and Belgium, Denmark and France 5% each; others 31%.

Drug consumption in 1992 in the public and private sector amounted to US$ 18.81 and US$ 48.651 million respectively. Consumption of the NGOs was US$ 0.178 million. The public sector drug budget for 1992 was estimated at US$ 20.81 million.

3. Drug policy and essential drugs list

There is a written and approved national drug policy called "National Drug Policy of the Republic of Yemen" developed in 1993. The policy covers aspects related to regulatory control, drug registration, drug procurement, and quality assurance. There is also a plan entitled "The National Pharmaceutical Programme Plan of Operation, 1993-1996”, developed in February 1993 and implementation adheres to the plan.

The Yemen Essential Drugs List formulated in 1991 comprises 284 products and is being used in the procurement of drugs for the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

The Supreme Board of Drugs and Medical Appliances (SBDMA) under the Ministry of Health is the authority responsible for drug regulation and registration in Yemen. The drug legislation comprises various ministerial resolutions, laws and government decrees. A consolidated legislation has not been enacted. Ministerial resolution No 143, 1975 deals with drug registration. The percentage of products on the market which are currently registered is 70%. Guidelines are available for applying for registration. Drugs imported by the private and public sector are subject to registration. There is also an illicit market.

4.2 Public and private procurement

The General Directorate and Medical Supplies under the Deputy Minister of Health procures drugs for the public sector. Procurement methods used are: open and restricted tender, negotiated procurement, direct purchase from manufacturers and wholesalers. Drugs are also obtained in the form of donations. In 1992, about 201 products were bought from former Czechoslovakia, Germany, India, Japan, the Netherlands and UK. Also, about five products were purchased from wholesalers in the country.

In the private sector, there are 35 importers operating. Procurement is done mainly through direct purchase from manufacturers/agents. In 1992, about 1140 products were procured from Belgium, Denmark, Egypt, France, Germany, Jordan, South Korea, Switzerland, UK and others.

4.3 Quality control of drugs

Quality control of drugs is done locally by the Drug Quality Control Laboratory in Sanaa, as well as abroad by the Pharmaceutical Laboratory of Cyprus and the Drug Quality Control Laboratory of Tunisia. There are no established criteria for regular quality control sampling from the local markets.

Out of 297 samples submitted in 1992 for quality control testing, 175 were analyzed by the Drug Quality Control Laboratory, of which three failed to pass the tests. Samples are collected and sent for testing after receipt and after payment, and following complaints.

There is no system for health personnel to report complaints regarding drug quality. No information is sent to the competent authority of the exporting country on drugs that have failed tests.

4.4 Inspection

The Inspection and Control Section of the Pharmacy Department is responsible for the inspection of drug establishments.

 


5. Operation of the WHO Certification Scheme

Yemen accepted the Scheme on 9 June 1982 and the competent authority is the Supreme Board of Drugs and Medical Appliances of the Ministry of Health.

The receipt of a Certificate of a Pharmaceutical Product is not a prerequisite for drug registration. There are no regulations or guidelines laid down in the drug legislation. But a Certificate of GMP compliance and a Free Sale certificate are requested for registration and they are included in guidelines for registration issued by SBDMA. Although a Certificate of a Pharmaceutical Product was not provided by the applicants, a Certificate for GMP compliance and a certificate of Free Sales were always provided (100%). Guidelines on how to obtain certificates are issued to importers, agents and wholesalers. Customs officers, public and private importers and others are informed about registered drugs by circular. Contacts with competent authorities in the exporting countries are made through intermediaries.

In the public sector Free Sale certificates and Batch Certificates are requested from manufacturers at the time of calling for tenders.

Observations:

• A Certificate of a Pharmaceutical Product is not requested as recommended by WHO.

• Free Sale certificates and GMP certificates are requested for drug registration .

• In the public sector, Free Sale and Batch Certificates are requested.

• A majority of the certificates are issued by health officials from the city, state and provincial governments and not by the competent authorities in the exporting countries.

• Local drug importers and distributors have a vague understanding of the WHO Certification Scheme.

• No quality control test is performed on imported drugs unless a question arises regarding potency, label, etc.

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