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
 

Jamaica

1. Population

2.4 million in 1992.

2. Pharmaceutical import and consumption

Imports of pharmaceuticals in 1992 were estimated to be US$ 19.5 million. Main exporting countries were: Canada 10%, Switzerland 4%, UK 30% and USA 21%. Consumption in 1992 in the public and private sector amounted US$ 3 and US$ 20.5 million respectively. The estimated public sector drug budget for 1992 was US$ 4.9 million and the national contribution and the external assistance were 64% and 36% respectively.

3. Drug policy and essential drugs list

There is no written and approved national drug policy but elements relating to drug regulatory control, drug registration, drug procurement are being practised.

The VEN List (Vital, Essential, Necessary) formulated in 1986 comprises 395 products. The list is being used in the procurement of drugs for the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

Drug registration and regulatory activities are described in the Food and Drugs Act of 1964, the Pharmacy Act of 1966, and the Food and Drugs Regulations of 3 March 1975. The latter is related to drug registration and has been amended by the Food and Drug Regulations of September 1992.

The Pharmaceutical Services Division within the Ministry of Health is responsible for pharmaceutical regulatory activities such as, registration, issuing of licenses, control of post registration activities, inspection, and sending random samples for testing by the Government Chemist/Caribbean Regional Drug Testing Laboratory.

Registration of drugs was introduced in 1975 and the percentage of drugs on the market registered at the time of the mission was 98%.

4.2 Public and private procurement

The Jamaican Commodity Trading Company Limited conducts importation of pharmaceuticals on behalf of the government.

There are 14 wholesalers importing and distributing drugs for the private sector.

In the public sector drugs are procured by means of open and restricted tender, negotiated procurement, direct purchase from manufacturers, wholesalers, and international suppliers. Also, donors supply in kind.

In 1992, about 250 products were purchased from manufacturers and their agents in Canada, France, Hungary, Panama, Puerto Rico, Trinidad, UK and USA. In addition, drugs were also bought from UNICEF and wholesalers abroad and donations were also received.

In the private sector the methods of procurement include negotiated procurement and direct purchase from wholesalers abroad. A total of 850 products were procured in 1992 from Canada, France, Hungary, Panama, Puerto Rico, Trinidad, UK and USA.

4.3 Quality control of drugs

The Government Chemist Laboratory tests the quality of drugs.

In 1992, 51 samples were sent for quality control and about 80% passed the tests. There is a post registration surveillance system in operation. Samples are collected and sent for analysis at the time of bidding and after receipt and after payment.

Drugs imported by the private sector are tested for their quality by the government on a small scale only. Post registration surveillance is also done on a small scale. There is no system for health professionals to report complaints regarding drug quality.

4.4 Inspection

There is inspection of pharmaceutical establishments.

 


5. Operation of the WHO Certification Scheme

Jamaica accepted the Scheme in 1980 and the responsible authority is the Director of Pharmaceutical Services, Ministry of Health and Social Security.

The receipt of a Certificate of a Pharmaceutical Product is not indicated as a prerequisite for drug registration in legislation, regulations and guidelines.* But a Free Sale certificate is requested for drug registration. Contacts with competent authorities are through importers and manufacturers. Information on drugs registered in the country is not communicated to relevant institutions.

* Since the assessment, a Certificate of a Pharmaceutical Product is routinely requested.

Request for a Certificate of a Pharmaceutical Product is not laid down in official procurement specifications. A Free Sale certificate is requested from manufacturers and their agents at the time of calling for tenders. But, guidelines on how to get the certificates are not given to importers. Certificates obtained are filed by product. All suppliers participating in tender are required to have their products registered in Jamaica. Tender committees do not, generally, award a tender for products that are not registered.

All drugs imported by the private sector are required to be registered and a Free Sale certificate is a prerequisite for registration.

Observations:

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

• Only a partial certification system is in place that fails to provide important information regarding pharmaceutical products offered for registration. The majority of the certificates lack information regarding the frequency and magnitude of inspection of the manufacturing plants by the competent regulatory authorities in the exporting country.

• The majority of the certificates were issued by health officials from the city, state and provincial governments and not by the competent authority in the exporting countries.

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

• Quality control tests are performed both on drugs randomly selected and on drugs about which questions arise regarding quality, potency, label, etc.

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