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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
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

ANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country

The country mission teams shall obtain information on the drug regulatory activities and those elements of the drug supply and quality assurance systems which are relevant to the operation of the WHO Certification Scheme. They will establish more precisely the extent to which the existing formal requirements of the WHO Certification Scheme are implemented in practice and provide an overall evaluation of the situation, including observations and recommendations. The missions will further educate and promote the use of the Scheme by giving practical suggestions on "how to" go about it.

Several indicators proposed in the protocol outline will facilitate the assessment of the use of the Certification Scheme; if the numerical data are difficult to establish, e.g. when the Scheme is only sparsely utilized, a descriptive term may be used.

1. GENERAL DATA ON THE PHARMACEUTICAL SECTOR

1.1 Economics
(when no exact figure exists, use best estimates)

1.1.1 State the total value (US$) of pharmaceutical imports in 1992. Specify also donations (volume and amount), when feasible. If needed, enter figures from 1990 and 1991.

1.1.2 State the major countries of origin of imported pharmaceuticals and the part of the total import market (% in value) that each of them has:

1.1.3 State the value (US$) of drug consumption in the country in 1992:

• in the public sector
• in the private sector
• in other sectors (e.g. NGO)

1.1.4 State the total public sector drug budget (US$) in 1992 and the respective contribution from national resources and from external assistance, expressed as percentages (%).

1.1.5 State total population in country in 1992.

1.2 Policy

1.2.1 Is there a written and approved national drug policy (give the name and date of the document)? Is there a drug policy in practice (describe)?

1.2.2 Are there any aspects of the policy relating to regulatory control including drug registration, drug procurement and quality assurance? Attach the relevant excerpts. Are there other specific policies, e.g. for drug registration, rational drug use, quality assurance, etc.?

1.2.3 Is there a plan for implementation of the drug policy, and is it being adhered to (give the name and date of plan)?

1.3 Essential Drugs Lists

1.3.1 Is there an essential drugs list (give the date of last issue)?

1.3.2 Is it used for procurement in the public sector, and if so how many products does it comprise?

2. INFRASTRUCTURE AND FUNCTIONING OF BODIES RESPONSIBLE FOR DRUG REGULATORY CONTROL, PROCUREMENT AND QUALITY ASSURANCE

When assessing drug regulatory activities, use an outline of these activities included in the document: "Guiding Principles for Small National Drug Regulatory Authorities" [see TRS 790, 64.79 (1990); WHO Drug Information, 3: 43-50 (1989)].

2.1 Infrastructure

Using an organogram, describe the names, functions and linkages between bodies responsible for:

a) drug regulation and registration;
b) procurement for the public sector (centralized or decentralized organizations);
c) procurement for the private sector (estimated number of importers);
d) quality assurance (administration and laboratories);
e) use of private inspection agencies (e.g. Bureau Veritas, SGS; specify and enter on organogram).

2.2 Functioning of drug regulation, procurement and quality assurance

2.2.1 Drug Regulation

 

2.2.1.1 State the title and date of enactment of the drug legislation (attach copy).

2.2.1.2 State the titles and dates of enactment of drug regulations/guidelines related to drug registration and quality assurance (attach copies).

2.2.1.3 State the date (year) of commencement of drug registration.

2.2.1.4 INDICATOR 1

State the percentage of pharmaceutical products on the market which are currently registered (licensed).

Format: percentage, calculated as the number of products registered divided by the total number of products on the market (or, from a random sample of products, the number registered divided by the total sample), expressed as percentage (%). If indicator is below 100%, explain the situation: e.g. parallel market, drugs offered by donor, imported by NGO's, etc.

Prerequisites: accessible information in the drug control administration on products which are registered and the total number of products on the market. If the latter information is not felt to be up-to-date, a random survey of 100 products in a retail pharmacy can be undertaken to determine the percentage registered.

2.2.2 Procurement of imported drugs for the public sector:


2.2.2.1 Which procurement methods are used?

Open tender

Restricted tender

Negotiated procurement

Direct purchase from manufacturers/agents

Direct purchase from wholesalers abroad

Direct purchase from international suppliers of essential drugs e.g. UNICEF, IDA, ECHO, other (specify)

Donor supply in kind

2.2.2.2 State the estimated number of imported products procured in 1992 from:

• manufacturers and their agents (specify countries of manufacture)

• wholesalers abroad and in the country (specify their location)

• international suppliers of essential drugs e.g. UNICEF, IDA, ECHO or other (please specify)

• donors (specify sources of drugs)

2.2.3 Procurement for the private sector:

2.2.3.1 Which procurement methods are used?

Negotiated procurement

Direct purchase from manufacturers/agents

Direct purchase from wholesalers abroad

Direct purchase from international suppliers of essential drugs e.g. UNICEF, IDA, ECHO, other (specify)

2.2.3.2 State the estimated number of products procured in 1992 from:

• manufacturers and their agents (specify main countries of manufacture, cf. answer to item 1.1.2);

• wholesalers abroad (specify the country);

• international suppliers of essential drugs (UNICEF, IDA, ECHO, etc.).

2.2.4 Quality control in the public sector:

2.2.4.1 Which drugs were sent for quality control in 1992 and upon which criteria were they selected?

2.2.4.2 How many samples were sent for quality control in 1992, and how many passed (express as a %)?

2.2.4.3 When are samples collected and sent for analysis?

at the time of bidding

after placing the order, pre-shipment

after receipt of drugs but before payment

after receipt and after payment

following complaints

2.2.4.4 Where are drugs tested?

in country (give name of department or laboratory)

abroad (describe costs and sample shipping arrangements and name/place of institution)

2.2.5 Quality control of drugs imported in the private sector:

• are imported products tested by importers?

• are imported products tested by the regulatory authority?

2.2.6 Is there a system or contact place for health personnel and patients to report complaints regarding drug quality? If it is so, how many complaints were received in 1992?

3. OPERATION OF THE WHO CERTIFICATION SCHEME

3.1 Formal status of the country in respect of the Scheme

3.1.1 Date of participation:

3.1.2 Designation and address on the competent authority (is the information provided to WHO Secretariat still correct?).

3.2 Use of WHO-type certificates in drug registration

3.2.1 Is the receipt of a WHO-type Certificate of a Pharmaceutical Product a prerequisite for drug registration? Where is this requirement formally laid down (in legislation/ regulations/guidelines)?

3.2.2 Attach the Product License application form.

3.2.3 INDICATOR 2

State the percentage of product licence applications received in 1992 for which a WHO-type Certificate of a Pharmaceutical Product was provided by the applicant. Separate three situations which illustrate partial or full use of 1975 WHO-type certificate:

(1) regulatory status of product only (a free sale certificate);

(2) GMP compliance only;

(3) the two above combines (a 1975 WHO-type certificate).

Format: the number of product licence applications supported by WHO-type Certificates of Pharmaceutical Products divided by the total number of product licence applications received in 1992, expressed as a percentage (%).

Prerequisites: operational drug registration system; requirement of WHO-type certificate for drug registration defined in regulations/guidelines; accessible accurate data in drug administration.

3.2.4 If WHO-type Certificates of Pharmaceutical Products have not been provided by applicants, what are the reasons?

3.2.5 If WHO-type Certificates of Pharmaceutical Products are sometimes rejected, what are the reasons?

the contents do not comply with the WHO 1975 format/content;

no signature/ designation/ stamp of the certifying country;

others (specify).

3.2.6 INDICATOR 3

State the percentage of WHO-type Certificates of Pharmaceutical Products received in 1992 which were rejected as invalid. Describe steps taken to verify authenticity of certificates, if any.

Format: the number of product licence applications supported by WHO-type Certificates of Pharmaceutical Products divided by the total number of product licence applications received in 1992, expressed as a percentage (%).

Prerequisites: as for indicator 2.

3.2.7 Were guidelines issued to agents/ wholesalers/ public sector procurement authorities on what WHO-type Certificates of Pharmaceutical Products are and on how to obtain them?

3.2.7.1 If so, describe the guidelines in a flow chart.

3.2.7.2 If WHO-type Certificates of Pharmaceutical Products are obtained through different channels in practice, describe the real situation with a separate flow chart.

3.2.8 Is the most up-to-date list of names and addresses of competent national authorities participating in the WHO Certification Scheme (as published in WHO information documents) readily available with the drug administration? Show front page of the WHO document of October 1992 (see also item 2.2.1).

3.2.9 How is the information on registered drugs communicated to customs authorities, public sector procurement authorities and private sector importers/retailers, and how frequently?

3.2.10 How are contacts made with competent authorities in exporting countries?

direct contacts

through intermediates (local agents, importers, manufacturers)

joint inspection visits to foreign manufacturers

other

3.2.11 State any other problems encountered with the use of the WHO Certification Scheme.

3.3 Use of the WHO Certification Scheme in drug procurement

3.3.1 Public sector

3.3.1.1 Are requests for WHO-type certificates laid down in official procurement specifications? If yes, describe or attach document.

3.3.1.2 Which documents are used (numbers designate the type of certificate):

(1) Certificate of a Pharmaceutical Product

(2) Statement of Licensing Status of a Pharmaceutical Product

(3) Batch Certificate of a Pharmaceutical Product

If possible, indicate the frequency of requests for the same product.

3.3.1.3 When are the documents requested?

• during supplier appraisal:

1

2

3

• at the time for calling for tenders:

1

2

3

• at the time for placing orders:

1

2

3

 

3.3.1.4 From whom are documents 1 - 3 requested?

 

• manufacturers and their agents:

1

2

3

• wholesalers:

1

2

3

• international suppliers of low-cost generics (UNICEF, IDA, EHCO etc.):

1

2

3

• donors:

1

2

3

• certifying authorities:

1

2

3

If possible, add percentage.

3.3.1.5 Are formal guidelines on how to obtain these documents given to importers?

3.3.1.6 Who prepares the guidelines and how are these distributed and used in practice? Does the procurement agency make use of WHO-type certificates supplied to drug registration authority?

3.3.1.7 How are these documents filed by the procurement body?

 

• by product:

1

2

3

• by manufacturer:

1

2

3

• other (specify):

1

2

3

3.3.1.8 When non-registered generic products are indicated in a tender document, are special licensing procedures (e.g. fast track registration) used?

3.3.1.9 Are products with documents 1 or 2 given preference by Tender Committees when selecting bids?

3.3.1.10 Are products with documents to be followed for requesting, issuing, monitoring, using and filing of documents 1 - 3 defined formally in:

 

• tender document terms and conditions:

1

2

3

• purchase order/supply contract terms and conditions:

1

2

3

• procurement procedures manual:

1

2

3

• other documents (specify):

1

2

3

3.3.1.11 INDICATOR 4

State the percentage of products purchased in 1992 for which a Certificate of a Pharmaceutical Product was received, categorized by supplier source.

Format: the number of product for which a WHO-type Certificate was received, divided by the total number of products purchased in 1992, expressed as a percentage (%). Define for each supplier source as categorized in 3.3.1.4. Use the data on total number of products purchased from each source in 1992 as estimated in 2.2.2.2.

Prerequisites: accessible drug procurement data. Effective monitoring and filing system for Certificates of Pharmaceutical Products.

3.3.1.12 INDICATOR 5

State the percentage of approved manufacturers who have submitted Certificates of Pharmaceutical Products.

Format: the number of approved manufacturers who have submitted Certificates of Pharmaceutical Products to the tender body, divided by the total number of approved manufacturers in 1992, expressed as a percentage (%).

Prerequisites: Pre-qualification system for manufacturers. Accessible drug procurement data. Effective monitoring and filing system for Certificates of Pharmaceutical Products.

3.3.1.13 INDICATOR 6

State the percentage of products purchased in 1992 for which Batch Certificates were received.

Format: the number of products for which Batch Certificates were received, divided by the total number of products purchased in 1992, expressed as a percentage (%).

Prerequisites: Accessible drug procurement data. Effective monitoring and filing system for Certificates of Pharmaceutical Products.

3.3.2 Private sector importation (in the absence of a registration system)

3.3.2.1 Are WHO-type Certificates of Pharmaceutical Products required for import of drugs by private importers?

3.4 Use of the WHO Certification Scheme in drug quality assurance

(Refer also to 2.2.4 and 2.2.5) separate situations as in 3.2.3 and complete questions on quality control as under 2.2.4 and 2.2.5.

3.4.1 INDICATOR 7

State the percentage of products which failed quality control in 1992 for which a Certificate of Pharmaceutical Product had been received.

Format: the number of failed products for which a Certificate of a Pharmaceutical Product had been received, divided by the total number of failed products in 1992, expressed as a percentage (%).

Prerequisites: Accessible information on QC failures. Effective monitoring and filing system for Certificates of Pharmaceutical Products.

3.4.2 INDICATOR 8

State the percentage of failed products in 1992 for which appropriate communication had been made to the Certifying Authority (and WHO) in accordance with the WHO Certification Scheme.

Format: the number of failed products in 1992 for which appropriate communication had been made to the Certifying Authority (and WHO), divided by the total number of failed products in 1992, expressed as a percentage (%).

Prerequisites: Accessible information on QC failures. Effective monitoring and filing system for Certificates of Pharmaceutical Products.

3.5 Field trial of 1992 Guidelines

(pertains to countries that agreed to participate in the field trial)

3.5.1 Describe experiences to date.

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