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Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (WHO/DAP, 1995, 156 p.)

(introductory text...) ACKNOWLEDGMENTS PREFACE EXECUTIVE SUMMARY 1. INTRODUCTION 2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT 3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work 4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES 5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES 6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES 7. SUMMARY ANALYSIS 8. CONCLUSIONS ANNEX 1: Resolution adopted by the Twenty-second World Health Assembly ANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly ANNEX 2 (b): Certificate of Pharmaceutical Product(S)1 ANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly ANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout) ANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce ANNEX 4 (b): Certificate of a Pharmaceutical Product ANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) ANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product ANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country ANNEX 6: List of Participants in the Study ANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country ANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization ANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country ANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme BACK COVER

ANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country

1. GENERAL DATA ON THE PHARMACEUTICAL SECTOR

1.1 Economic data

1.1.1 Total value of domestic pharmaceutical production (average of 1990-92; pharmaceuticals only) per year in US$.

1.1.2 Total value of pharmaceutical exports (as in 1.1.1.); the percentage of exportation in the total production (in value terms).

1.1.3 Principal directions of pharmaceutical export: state main importing countries, give the part (in %) of each country in the total.

1.2 Pharmaceutical infrastructure

1.2.1 Number of pharmaceutical manufacturers.

1.2.1.1 If possible, give the number of pharmaceutical plants (separate inspection sites).

1.2.2 Number of pharmaceutical manufacturers which export a part of their production.

1.2.2.1 Number of pharmaceutical manufacturers which produce exclusively for export.

1.2.3 Total number of pharmaceutical wholesalers.

1.2.3.1 If possible, give the number of warehouses (separate inspection sites).

1.2.4 Number of pharmaceutical wholesalers which are involved in the export activities.

1.2.4.1 Number of pharmaceutical wholesalers which carry out export activities exclusively.

1.2.5 Other institutions involved in the exportation of pharmaceuticals (if possible give the relevant numbers):

· hospital pharmacies
· charitable associations
· others (specify):

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

2.1 Infrastructure

Using an organogram, give the names, functions and linkages between bodies (federal and states) responsible for:

· general drug regulatory activities and drug registration;
· regulatory control over drug exportations;
· quality assurance (administrative bodies, laboratories, inspection, etc.);

Include a short commentary describing the linkages between different institutions and bodies.

2.2 Functioning of drug regulation, control over exported pharmaceuticals and drug quality assurance

2.2.1 Drug regulation

2.2.1.1 State the titles and dates of enactment of drug laws, including those related to the exportation of pharmaceuticals; describe important elements of the legislation.

2.2.1.2 State the titles and dates of enactment of drug regulations and guidelines related to drug registration and quality assurance including those related to the exportation of pharmaceuticals; describe important elements of these regulations.

2.2.1.3 Is there a special authorization necessary for the exportation of pharmaceuticals?

If Yes: How is it regulated?

· by manufacturer?	Yes	No
· by product?	Yes	No
· by batch?	Yes	No
· otherwise (explain):

2.2.1.4 Are there any special regulations concerning the collection of donations of drugs that are to be sent abroad?

If Yes: detailed explanation

2.2.1.5 INDICATOR 1

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

If the value of the indicator is below 100%, explain the situation.

2.2.1.6 INDICATOR 2

State the number of pharmaceutical products that are registered exclusively for exportation.

2.2.2 Quality control

2.2.2.1 State names and addresses of laboratories that are approved for performing quality control of pharmaceuticals.

2.2.2.2 Which drugs were subjected in 1992 to quality control in laboratories and upon which criteria were these drugs selected; was there any special programme of control of pharmaceuticals intended for exportation?

2.2.2.3 Total number of samples sent for quality control in 1992 and how many of them passed (in %); state main reasons for rejection.

2.2.2.4 When are samples collected and forwarded for analysis:

· before registration?	Yes	No
· before an export licence is issued?	Yes	No
· during post-marketing surveillance?	Yes	No
· after a complaint from the importing country is received?	Yes	No
· other reasons (explain)

2.2.3 Pharmaceutical inspection

2.2.3.1 Where is the inspectorate located? At central, federal or regional state level?

2.2.3.2 Is there a special group of inspectors who are specialized in the inspection of manufacturers? Yes

No

If Yes: give number and explain details

2.2.3.3 How often are drug manufacturers and wholesalers inspected?

2.2.3.4 Is a report produced after each inspection? To whom is it sent?

2.2.3.5 Do the inspectors have special instructions or control programmes related to products for exportation?

If Yes: explain

2.2.3.6 Are there any systems in force of mutual recognition of inspections with other countries?

If Yes: explain details.

2.2.4 Reporting of side-effects

2.2.4.1 Is there any formal system for reporting side-effects of drugs?

2.2.4.2 If Yes, briefly explain its organisation.

2.2.5 Drug recalls

2.2.5.1 Is there any formal system for reporting of complaints concerning quality of drugs?

If Yes: explain

· where is it located?

· what was the number of complaints registered in 1992?

2.2.5.2 Is there any formal system of drug recalls?

If Yes:

· describe how it is operating.

· describe how is it organized.

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 of the competent authority (is the information provided to the WHO Secretariat still correct?)

3.2 Origin and type of certificates issued

3.2.1 Certificates issued by the competent authority.

3.2.1.1 WHO-type product certificates.

- version 1975	Yes	No
- version 1988/1992	Yes	No

3.2.1.2 WHO-type Statement of Licensing Status of a Pharmaceutical Product

Yes
No

3.2.1.3 Non-WHO type certificates (discouraged by WHO guidelines)

- free sale certificates	Yes	No
- GMP certificates that are not product specific (i.e. issued for a manufacturer generally)	Yes	No

3.2.1.4 Batch certificates Yes
No

3.2.2 Certificates issued by manufacturers/exporters

3.2.2.1 WHO-type batch certificates Yes
No

3.2.2.2 Analytical certificates Yes

No

3.3 Format of product certificates used by the competent (certifying) authority and procedures related to their issue

3.3.1 Type of certificate used (see item 3.2.1.1.)

3.3.2 In what language(s) is the certificate issued?

3.3.3 Does the form for the certificate contain a WHO emblem?

If Yes, was any prior agreement obtained from any WHO unit?

3.3.4 Does the certificate contain any mention that its format is established in accordance with WHO recommendations?

3.3.5 Does the certificate contain a date of its issue?

3.3.6 Is an official seal (stamp) placed on the certificate? If the certificate contains more than one page, is the seal placed on each page?

3.3.7 Are any steps taken (use of special paper for the form, special type of print, etc.) to prevent counterfeiting?

3.3.8 How many copies of a certificate are issued? If more than one, explain the destination of each copy.

3.3.9 Is the certificate issued free of charge? Yes

No

If No: what is the amount of the fee?

3.3.10 How are the copies of issued certificates filed by the issuing office?

- by product?	Yes	No
- by manufacturer?	Yes	No
- other (specify):

3.4 Use of certificates for exported products

3.4.1 Does any formal administrative control over the exportation of pharmaceutical products exist? Yes
No

If Yes, what authority is responsible for such control?

3.4.2 Is the issue of a WHO-type certificate a condition for obtaining an export licence?

If No, are exporters generally interested in obtaining product certificates on a voluntary basis?

3.4.3 If the interest of exporters in obtaining product certificates on a voluntary basis is slight, what are the principal reasons?

3.4.4 What is the usual procedure when a request for a product certificate is received by the certifying authority? Give details of contacts with the registration authority and pharmaceutical inspection.

3.4.5 What is the procedure when consecutive stages of manufacture of the product take place at different plants, especially if such plants are located abroad?

3.4.6 Were special guidelines issued for manufacturers and exporters on the procedure to obtain a WHO-type product certificate?

If Yes, attach a copy.

3.4.7 INDICATOR 3

Give the total number of WHO-type product certificates issued in 1992 by the competent authority (see item 3.2.1.1.).

3.4.8 INDICATOR 4

Give the number of manufacturers and wholesalers which obtained product certificates for their products in 1992.

3.4.9 Are product certificates issued also for products that are not registered for the use of the country?

If Yes, what are the reasons and how it is indicated in the certificate?

3.4.10 INDICATOR 5

Give the number of product certificates issued in 1992 for products not registered for use in the country.

- manufactured in the country?	Yes	No
- manufactured abroad?	Yes	No

3.4.11 Are requests for product certificates sometimes rejected by the certifying authority?

If Yes, what are the principal reasons?

3.4.12 INDICATOR 6

Give the number of requests for product certificate rejected by the certifying authority in 1992.

3.4.13 Are there cases when a product certificate is requested more than once for the same product (certificate renewal)?

If Yes, what are the reasons and is there a usual validity period for a certificate?

3.4.14 What events are considered important enough to inform the importing country about changes in the approval status of the product or the status of its manufacturer:

· Renewal of product licence	Yes	No
· Modification in the product licence	Yes	No
· Changes in the manufacturer's licence	Yes	No
· Negative results of an inspection in the manufacturer's plant	Yes	No
· Other reasons (specify)

3.4.15 Is the information on issues mentioned in item 3.4.14 communicated to exporters?

If Yes, describe the procedure.

3.4.16 Is there a post-marketing surveillance system for the quality of pharmaceutical products and does it include the analysis of samples of exported products?

3.4.17 INDICATOR 7

Give the number of products rejected in 1992 when testing samples in the course of post-marketing surveillance for which product certificates have been issued.

3.5 Contacts with the authorities in importing countries

3.5.1 Were there in 1992 any direct contacts with the competent authorities in importing countries?

Yes
No

If Yes, list the countries.

3.5.2 Are requests for a product certificate received sometimes directly from the competent authority of importing countries?

Yes
No

If Yes, list the countries.

3.5.3 Were any requests for information on pharmaceutical products or manufacturers received in 1992 from competent authorities of importing countries according to the WHO Certification Scheme?

If Yes, describe their type and specify countries.

3.5.4 Were any communications received in 1992 from importing countries on quality failures of exported products which led to opening of an inquiry?

If Yes, give the number of communications and describe more important ones.

3.5.5 INDICATOR 8

State the percentage of cases when the complaint was confirmed after testing product samples taken from the manufacturer or found on local market.

3.6 New format of WHO-type certificates introduced in 1992 guidelines

3.6.1 Is the new format of certificates already in use? Yes
No

If Yes, since when?

If No, is their use under consideration?

3.6.2 What are the opinions about the new formats?