WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Close this folderAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
View the document1. Introduction
Open this folder and view contents2. Steps of the procedure
View the documentAppendix Provisions for evaluators of product dossiers and for inspectors (team member participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products
View the documentReferences
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

Appendix Provisions for evaluators of product dossiers and for inspectors (team member participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products

In the course of discharging your functions as an expert adviser to WHO under the attached Agreement for the Performance of Work (APW), you will gain access to certain information, which is proprietary to WHO or entities collaborating with WHO, including the manufacturers of the product(s) which need to be assessed as part of the quality assessment procedure by WHO. You undertake to treat such information (hereinafter referred to as “the Information”) as confidential and proprietary to WHO or the aforesaid parties collaborating with WHO. In this connection, you agree:

(a) not to use the Information for any other purpose than discharging your obligations under the above-mentioned APW; and

(b) not to disclose or provide the Information to any person who is not bound by similar obligations of confidentiality and non-use as contained herein.


However, you will not be bound by any obligations of confidentiality and non-use to the extent that you are clearly able to demonstrate that any part of the Information:

(i) was known to you prior to any disclosure by or on behalf of WHO (including by the manufacturer(s)); or

(ii) was in the public domain at the time of disclosure by or on behalf of WHO (including the manufacturer(s)); or

(iii) becomes part of the public domain through no fault of your own; or

(iv) becomes available to you from a third party not in breach of any legal obligations of confidentiality.


You also undertake not to communicate your deliberations and findings and/or those of the team(s) of experts in which you will participate, as well as any resulting recommendations to, and/or decisions of, WHO to any third party, except as explicitly agreed by WHO.

You will discharge your responsibilities under the above-mentioned APW exclusively in your capacity as an expert adviser to WHO. In this connection, you confirm that the information disclosed by you in the Declaration of Interest is correct and that no situation of real, potential or apparent conflict of interest is known to you, including that you have no financial or other interest in, and/or other relationship with, a party, which:

(i) may have a vested commercial interest in obtaining access to any part of the Information referred to above; and/or

(ii) may have a vested interest in the outcome of the evaluation of the product(s), in which you will participate (such as the manufacturers of those products or of competing products).


You undertake to promptly advise WHO of any change in the above circumstances, including if an issue arises during the course of your work for WHO.

I hereby accept and agree with the conditions and provisions contained in this document.

Signed ________________________________________

Name (typewritten) ______________________________

Institute _______________________________________

Place _________________ Date ___________________

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