WHO Technical Report Series, No. 981 - World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report It is agreed furthermore that nothing contained in this Undertaking shall be construed as a waiver of any of the privileges and immunities enjoyed by WHO under national and international law, and/or as submitting WHO to any national court jurisdiction. Agreed and accepted by the Undersigned: Signature: Name: Title in NMRA: Place and date: WHO Technical Report Series No. 981, 2013 178
Annex 4 Appendix 2 Consent of WHO prequalification holder for WHO to share information with NMRA confidentially under the Procedure Reference is made to the attached expression of interest for the assessment and accelerated national registration under the Procedure of the following WHOprequalified pharmaceutical product (hereafter referred to as "the Product") in [country]. 1 WHO prequalification details: WHO prequalification reference number: Date of prequalification (dd/mm/yyyy): Date of requalification (if applicable): WHO prequalification holder: 2 Application details: Name of entity: Street: City and country: E-mail: Phone: (“the Applicant”) The WHO prequalification holder hereby consents to WHO/PQP providing the following information and documentation to the NMRA of [country] (“the NMRA”) for the assessment and accelerated registration of the Product in the country under the Procedure and to freely discuss the same with the aforesaid NMRA for this purpose: ■■ the full WHO/PQP assessment and inspection outcomes (reports); 1 Please complete a separate form of this Annex for each country. 2 If the applicant for national registration is not the same as the WHO prequalification holder, the WHO prequalification holder must confirm to the NMRA and to WHO/PQP by an authorization letter (as per the template annexed to Appendix 3, Part A) that the applicant is acting for, or pursuant to rights derived from, the WHO prequalification holder, and that the prequalification holder agrees with the application of the Procedure in the country concerned. 179
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The Expert Committee on Specificati
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W H O T e c h n i c a l R e p o r t
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Contents WHO Expert Committee on Sp
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12.4 Proposal for a procedure on sa
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WHO Expert Committee on Specificati
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2. General policy 2.1 Cross-cutting
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4. Quality control - International
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7. Quality assurance - new approach
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9. Prequalification of priority ess
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11. Prequalification of quality con
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14. Miscellaneous 14.1 Quality assu
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WHO Technical Report Series, No. 98
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Annex 1 Release procedure for Inter
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Annex 2 WHO guidelines on quality r
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Annex 2 While the choice of the too
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Annex 2 ■■ The level of effort,
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Annex 2 within companies and, where
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Annex 2 risk analysis The estimatio
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Annex 2 3.3 Knowledge of the produc
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Annex 2 During risk control activit
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Annex 2 diagrams and appropriate re
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Annex 2 Similarly, contract staff m
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Annex 2 4.5 QRM application during
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Annex 2 Among others, QRM methodolo
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Annex 2 ■■ ■■ ■■ ■■
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Annex 2 All documentation related t
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Annex 2 6. Risk management tools A
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Annex 2 This table is a very basic
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Annex 2 Table 3 continued Risk mana
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Annex 3 WHO guidelines on variation
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Annex 3 3.2. P.5 Control of FPP 142
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Annex 3 to implementation, assessme
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Annex 3 WHO/PQP should be notified
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Annex 3 2.1.2 Minor variation (Vmin
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Annex 3 active pharmaceutical ingre
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Annex 3 Table continued Description
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Annex 3 Table continued Documentati
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Annex 3 Table continued Conditions
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WHO Technical Report Series, No. 981 - World Health Organization

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