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
 

Myanmar

1. Population

42 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 20 million. Main exporting countries were: Australia, China, Germany, India, the Netherlands and Thailand.

Drug consumption in 1992 in the public and private sector amounted to US$ 5 and US$ 15 million respectively. The value of drug consumption by NGOs was US$ 0.5 million. The total public sector drug budget in 1992 was US$ 49 million.

3. Drug policy and essential drugs list

There is a national drug policy written and approved in February 1991. The policy covers all aspects relating to drug regulatory control, drug registration, drug procurement and quality assurance. There is no plan to implement the policy.

The Essential Drugs List of Myanmar was formulated in June 1989 and is used for procurement in the public sector. The list comprises 208 products.

4. Infrastructure and functioning

4.1 Drug regulation and registration

The National Drug Law was enacted on 30 October 1992. Regulations on drug registration, based on the 1992 Law, exist and are applied in practice but not yet formally enacted. There are no regulations on pharmaceutical inspection and sample testing.

The Drug Advisory Committee (DAC) at the Department of Health is responsible for the registration of drugs. Registration started 1974 but in the present form registration became operational in 1989. In the public sector all the drugs purchased by the Central Medical Stores are registered by DAC. The majority of the drugs imported by the Medicines and Medical Equipment Enterprise are also registered. Registration has not been extended to products imported by private sector.* There are no administrative mechanisms in the Ministry of Health for the surveillance of the quality of products distributed in the free market.

* Since the assessment, drug registration has been introduced in the private sector and about 50% of the products are registered.

 

4.2 Public and private procurement

There are three main drug supply channels in Myanmar. Public health units receive drugs from the Central Medical Stores (CMS). Procurement by CMS is made through restricted tender and direct purchase from international suppliers. In 1992, 62 products were purchased from manufacturers in Australia, Germany, Malaysia, Thailand and UK and 164 products from wholesalers.

A parallel distribution system for pharmaceuticals is also in operation under the Ministry of Trade. The Medicines and Medical Equipment Enterprise does the procurement and distribution on behalf of the Ministry of Trade. The majority of the drugs imported by the organization are registered.

Numerous importing companies also operate in the free market by importing drugs from China, India and Thailand through barter arrangements. Procurement in the private sector is through negotiation and direct purchase from manufacturers and wholesalers.

4.3 Quality control of drugs

Quality control of drugs imported by the CMS is limited in most cases to visual inspection by the CMS staff. In recent years, very few samples of products imported by the CMS were actually tested by the Drug Control Laboratory in Yangon and the Laboratory of Myanmar Pharmaceutical Factory in Yangon. Testing is done when external signs of deterioration are seen. Drugs imported by the private sector are not tested.

4.4 Inspection

There is no inspection unit and as a result no inspection of establishments.

 


5. Operation of the WHO Certification Scheme

The Scheme was accepted by Myanmar on 11 September 1979 and the responsible authority is the Director General, Department of Health, Yangon. 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 formally laid down in guidelines. The Scheme is applied in the public sector but not in the private sector. In 1992, 84% of product applications received were accompanied by a Certificate of a Pharmaceutical Product. Certificates were sometimes rejected because designations of the authorities on the certificates varied from those indicated on the WHO list.

Contacts with competent authorities are made directly or through importers and manufacturers. Information on drugs registered in the country is communicated to relevant institutions through an updated list of registered products by the Department of Health.

Observations:

• A Certificate of a Pharmaceutical Product is a prerequisite for drug registration.

• Only drugs imported by the public sector are registered at present.

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

• Quality assurance of marketed drugs is not satisfactory.

• Batch certificates are not requested for imported drugs.

• Designations of authorities on the certificates sometimes differ from those indicated in the WHO list.

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