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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 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country


Study no: ___________________________________________

Country: ___________________________________________

Date of data collection: ________________________________

Names of data collector(s): _____________________________

International: ________________________________________

National: ___________________________________________

Name of transmittor: __________________________________

Date: ______________________________________________

GENERAL DATA ON THE PHARMACEUTICAL SECTOR

Economic

1 What is the country’s population?

Million

2 What was the total estimated value of pharmaceutical imports in 1992?

US$

3 What are the major countries of origin of imported pharmaceuticals... And the respective share from the total import each country has?

Country

%

Country

%

1

   

5

   

2

   

6

   

3

   

7

   

4

   

8

   

4 What was the value of drug consumption in the public sector in 1992?

US$

US$

5 What was the value of drug consumption in the private sector in 1992?

US$

6 What was the value of drug consumption of the NGO’s in 1992?

US$

7 What was the total public sector drug budget in 1992?

Local Currency

US$

8 What was the percentage of contribution from:

a

National resources

%

b

External assistance

%

Policy

9 Is there a written and approved national policy?

(1 = Yes, 2 = No, 3 = in “Process” draft)


enter number here

10 If yes (1): what is the name and date of document?

NAME:
__________________________________
__________________________________

DATE:

____/

___/

____/

day

mo

year

If draft (3): what is the name and date of the document?

NAME:
__________________________________
__________________________________

DATE:

____/

___/

____/


day

mo

year

enter number here

11 Are there aspects of the policy relating to:

(1 = Yes, 2 = No)

regulatory control


drug registration


drug procurement


quality assurance



enter number here

If yes (1), could you attach the relevant excerpts (specify title):
________________________________________________
________________________________________________
________________________________________________

12 Is there a plan for implementation of the drug policy?

(1 = Yes, 2 = No)


enter number here

13 If yes:

a Is it being adhered to?

(1 = Yes, 2 = No)


enter number here

b What is the name and date of the plan?

Name:
__________________________________
__________________________________

____/

___/

____/

day

mo

year

Essential drugs lists

14 Is there an essential drugs list?

(1 = Yes, 2 = No, 3 = Draft)


enter number here

15 If yes (1):

a what is the name of the list?
__________________________________
__________________________________

b how many products does it comprise?


enter number here

c enter number here c what is the date of the last issue?

____/

___/

____/

day

mo

year

d is it used for procurement in the public sector?

(1 = Yes, 2 = No)


enter number here

If no (2):

16 is it expected to be used in the future?

(1 = Yes, 2 = No)


enter number here

17 If draft (3):

a what is the date of the draft?

____/

___/

____/

day

mo

year

b how many products does it comprise?
______________________________
______________________________
______________________________


enter number here

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

Infrastructure

18 Could you mention the name(s), function(s) and linkage(s) between bodies responsible for A through F below?

a Drug regulation

b Drug registration

c Procurement for the public sector (centralized and decentralized organization)

d Procurement for the private sector (estimated numbers of importers)

e Quality assurance (administration and laboratories)

e1 administration
e2 laboratories
e3 inspection

f Private inspection agencies


Name(s)

Function(s)

Linkage(s)

a

     

b

     

c

     

d

     

e1

     

e2

     

e3

     

f

     

Functioning of drug regulation, procurement and quality assurance

19 Does legislation on drug regulation exist?

(1 = Yes, 2 = No)


enter number here

21 If yes (1): Please input law title(s) with date(s) of enactment

LAW TITLES

Enactment
Date(s)

   
   
   
   

Remarks:
_______________________________
_______________________________
_______________________________
_______________________________
_______________________________

22 Do drug regulations related to drug registration exist?

(1 = Yes, 2 = No, 3 = Draft)


enter number here

23 If yes (1):

a What are their titles?
_______________________________
_______________________________
_______________________________

b What was the date of regulation for registration?

____/

___/

____/

day

mo

year

c What was the date of announcement of notification?

____/

___/

____/

day

mo

year

d What was the date of guidelines for registration?

____/

___/

____/

day

mo

year

e What was the date when registration started?

____/

___/

____/

day

mo

year

24 Do drug regulations related to drug quality exist?

(1 = Yes, 2 = No, 3 = Draft)


enter number here

Remarks:
__________________________________
__________________________________
__________________________________
__________________________________

INDICATOR 1

25 What are the percentages of pharmaceutical products on the market which are currently registered?

%

Remarks:
__________________________________
__________________________________
__________________________________
__________________________________

Procurement of imported drugs for the public sector

26 Which of the following procurement methods is used?


(Please enter the corresponding numbers)

1 Open tender


2 Restricted tender


3 Negotiated procurement


4 Direct purchase from manufacturers/agents


5 Direct purchase from wholesalers abroad and in country


6 Direct purchase from international suppliers of low cost quality essential drugs, e.g. UNICEF, IDA, ECHO, other - specify


7 Donor supply in kind


8 Other (specify):


27 Were any imported products procured in 1992 from any of the following?

a Manufacturers and their agents?

(1 = Yes, 2 = No)


enter number here

If yes (1):

i. What is the estimated number of imported products?


ii. What are their countries of manufacture?










b Wholesalers abroad and in country?

(1 = Yes, 2 = No)


enter number here

If yes (1):

i. What is the estimated number of products?


ii. What are their locations?








c International suppliers of low cost essential drugs, e.g, UNICEF, IDA, ECHO?

(1 = Yes, 2 = No)


enter number here

If yes (1), specify sources of drugs

 

Sources

 

Number of Products

1

       

2

       

3

       

4

       

d Donors?

(1 = Yes, 2 = No)


enter number here

Procurement for the private sector

28 Which of the following procurement methods are used?

1 Negotiated procurement

(Please enter the corresponding number)

2 Direct purchase from manufacturers/agents

 

3 Direct purchase from wholesalers abroad

 

4 Direct purchase from international suppliers of low cost
quality essential drugs, e.g. UNICEF, IDA, ECHO, etc.

 

5 Other (specify):

 
   
   
   

Remarks:
________________________
________________________
________________________
________________________

29 Were any products procured in 1992 from any of the following:

a Manufacturers or their agents?

(1 = Yes, 2 = No)


enter number here

If yes (1):

i What is the estimated number of products?


enter number here

ii What are the countries of manufacture?
_________________________________
_________________________________
_________________________________
_________________________________

b Wholesalers abroad?

If yes (1):

(1 = Yes, 2 = No)


enter number here

i What is the estimated number of products?


enter number here

ii What are their locations?
_________________________________
_________________________________
_________________________________
_________________________________

c International suppliers of low cost essential drugs, e.g., UNICEF, IDA, ECHO, etc.?

(1 = Yes, 2 = No)


enter number here

If yes (1), specify:
_________________________________
_________________________________
_________________________________
_________________________________

Quality assurance in the public sector

30 Have any drugs been sent for quality control in 1992 in the public sector?

(1 = Yes, 2 = No)


enter number here

If yes(1):

a Which drugs were sent?
_______________________________
_______________________________
_______________________________

b What were the reasons for their selection?
_______________________________
_______________________________
_______________________________

c Are there any criteria set for regular quality control sampling?
_______________________________
_______________________________
_______________________________

(1 = Yes, 2 = No)


enter number here

If yes (1), specify:

31 How many samples were sent for quality control in 1992?


enter number here

32 How many samples passed?

%

Remarks:
________________________________
________________________________
________________________________
________________________________

33 When are samples collected and sent for analysis?

1 At the time of bidding

(Please enter the corresponding numbers)

2 After placing the order, pre-shipment

 

3 After receipt of drugs but before payment

 

4 After receipt and after payment

 

5 Following complaints

 

34 Where are drugs tested?


(Please enter the corresponding numbers)

1 In the country


2 Abroad

 

35 If 1:

a What is the name of the department or laboratory?
_______________________________________
_______________________________________
_______________________________________

b Were there any fee charges?

(1 = Yes, 2 = No)


Enter number here

c If yes, indicate the fee:

36 If 2:

a What is the name and place of the institution?

b What are the costs and shipping arrangements?

Quality assurance of drugs imported in the private sector

37 Are imported products tested by importers?

(1 = Yes, 2 = No)


enter number here

38 Are imported products tested by regulatory authorities?

(1 = Yes, 2 = No)


enter number here

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

39 Is there any system for health personnel to report complaints regarding drug quality?

(1 = Yes, 2 = No)


enter number here

40 If yes (1),

a How many complaints were received in 1992?


enter number here

b Give a brief summary of its function
_________________________________
_________________________________
_________________________________
_________________________________

OPERATION OF THE WHO CERTIFICATION SCHEME

Formal status of the country in respect of the Scheme

41 Is your country participating in the WHO Certification Scheme?


enter number here

(1 = Yes, 2 = No)

42 If yes (1):


enter number here

a What was the date of participation?

____/

___/

____/

day

mo

year

b What is the designation and address of the competent authority?
_______________________________________
_______________________________________
_______________________________________

c Is this information included in the last issue of the WHO Secretariat list?

(1 = Yes, 2 = No)


enter number here

Use of WHO Certification Scheme in drug registration

N.B. Indicate “Not Applicable” where the scheme is not yet in use.

43 Is the receipt of a WHO-type certificate of a pharmaceutical product (i.e. including all elements) a pre-requisite for drug registration?

(1 = Yes, 2 = No, 3 = under development)


enter number here

44 If yes (1): where is this requirement formally laid down?

1 In legislation

(Please enter the corresponding numbers)

2 Regulation

 

3 Guidelines

 

Remarks:
_________________________________
_________________________________
_________________________________

N.B. Product licence application to be attached.

45 Are elements of it used?

(1 = Yes, 2 = No)


enter number here

If Yes (1):

Which ones:
__________________________________
__________________________________
__________________________________

46 Have the WHO certificates of pharmaceutical products always been provided by the applicants?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

47 If no (2):

INDICATOR 2

a What is the percentage of product licence applications received in 1992, for which a WHO certificate of a pharmaceutical product was provided by the applicant?

%

b What are the reasons for not providing the certificate?
________________________________________
________________________________________
________________________________________

48 Has the WHO certificate of pharmaceutical products ever been rejected?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

49 If yes (1):

a What were the reasons for rejection?


(Please enter the corresponding numbers)

1 Content did not comply with WHO format

 

2 No signature/designation/stamp of the certifying authority

 

3 Other (specify):

 

 

 

 

INDICATOR 3

b What is the percentage of WHO certificates received in 1992 which were rejected as invalid?

%

50 Were guidelines on which WHO product certificates and how to obtain them issued to any of the following?

 

(Please check the corresponding boxes)

1 Agents

 

2 Wholesalers

 

3 Public sector procurement authorities

 

51 If yes (1), what are those guidelines?
__________________________________
__________________________________
__________________________________

52 Are the WHO product certificates obtained through different channels?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

53 If Yes (1) specify:
__________________________________
__________________________________
__________________________________

54 Is the most up-to-date list of names and addresses of competent national authorities participating in the WHO Certification Scheme readily available with the drug administration?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

55 If no (2), give the reasons:
__________________________________
__________________________________
__________________________________

56 In what way and how frequently is the information on registered drugs communicated to the following?

a Customs authorities
__________________________________
__________________________________
__________________________________

b Public sector procurement authorities
__________________________________
__________________________________
__________________________________

c Private sector importers/retailers
__________________________________
__________________________________
__________________________________

d Other means
__________________________________
__________________________________
__________________________________

57 Which of the following methods are used for contact with competent authorities in exporting countries?

1 Direct contact

(Please enter the corresponding numbers)

2 Through intermediaries:

 

a Local agents

 

b Importers

 

c Manufacturers

 

3 Joint inspection visit to foreign manufacturers

 

4 Other

(specify):





58 Are there any problems encountered with the use of the WHO Certification Scheme?

(1 = Yes, 2 = No)


enter number here

59 If yes (2) specify:
_____________________________
_____________________________
_____________________________

Use of the WHO Certification Scheme in drug procurement:

N.B. Indicate “Not Applicable” (3) where the scheme is not yet in use.

Public sector

60 Are requests for WHO certificates laid down in official procurement specifications? here

(Yes = 1, No = 2, Not Applicable = 3)


enter number

61 If yes (1): attach document and specify titles:
_____________________________
_____________________________
_____________________________

62 Which of the following documents are used?

DOC A: Certificate of a pharmaceutical product

 

DOC B: Statement of licensing status of a pharmaceutical product

 

DOC C: Batch certificate of a pharmaceutical product

 

63 When are the documents requested?


Doc. A

Doc. B

Doc. C

1 During supplier appraisal




2 At the time of calling for tenders

 

3 At the time of placing orders

 

64 From whom are documents A-C requested?


Doc. A

Doc. B

Doc. C

1 Manufacturers or their agents




2 Wholesalers

 

3 International suppliers of low cost generics,e.g., UNICEF, IDA, ECHO, etc.

 

4 Donors




5 Certifying authorities




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

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________
_________________________________

66 If yes (1):

Explain how they are obtained:

Are WHO certificates supplied to the drug registration authority consulted?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________
_________________________________

67 How are these documents filed by the procurement body (authority)?

 


Doc. A

Doc. B

Doc. C

1 By product




2 By manufacturer

 


 

3 Other, specify:
_________________________________
_________________________________

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________
_________________________________


68 When generic products are indicated in a tender document, are special licensing facilities, e.g., “fast track registration” used?

(1 = Yes, 2 = No)


enter number here

69 If yes (1): specify:
_________________________________
_________________________________
_________________________________
_________________________________

70 Are products with documents “A” or “B” given preference by tender committees when selecting bids?

(1 = Yes, 2 = No)


enter number here

If yes (1): explain:
_________________________________
_________________________________
_________________________________
_________________________________

72 Are the procedures to be followed for requesting, issuing, monitoring, filling in and using documents A, B and C defined formally in the following:

 

Doc. A

Doc. B

Doc. C

1 Tender document terms and conditions




2 Purchase order/supply contract terms and conditions




3 Procurement procedures manual




4 Other document - specify

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

INDICATOR 4

73 What is the % of products purchased in 1992 for which a certificate of a pharmaceutical product was received, categorized by supplier source?

%

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

INDICATOR 5

74 What is the percentage of approved manufacturers who have submitted certificates of pharmaceutical products?

%

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

INDICATOR 6

75 What is the percentage of products purchased in 1992 for which batch certificates were received?

%

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

Private sector

76 Are WHO certificates of pharmaceutical products required for import of drugs by private importers?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

Use of the WHO Certification Scheme in drug quality assurance enter number here

77 Are there any products which failed quality control in 1992, for which a certificate of a pharmaceutical product had been received?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

INDICATOR 7

78 If Yes (1): what is the percentage?

%

79 Are there any failed products for which appropriate communication has been made to the certifying authority and WHO in accordance with WHO Certification Scheme guidelines in 1992?

(1 = Yes, 2 = No, 3 = Not Applicable)


enter number here

Remarks:
_________________________________
_________________________________
_________________________________
_________________________________

INDICATOR 8

80 If yes (1): what is the percentage?

%

 

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