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
Close this folder2. Steps of the procedure
View the document2.1 Publication of Invitation for Expression of Interest (EOI)
View the document2.2 Submission of Dossiers
View the document2.3 Screening of dossiers submitted
View the document2.4 Dossier assessment
View the document2.5 Site Inspection
View the document2.6 Report and outcome of evaluation
View the document2.7 Assessment results
View the document2.8 Procurement, sourcing and supply
View the document2.9 Re-evaluation
View the document2.10 Testing of samples
View the document2.11 Monitoring of Complaint(s)
View the document2.12 Cost Recovery
View the document2.13 Confidentiality Undertaking
View the document2.14 Conflict of Interest
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
 

2.2 Submission of Dossiers

Each interested manufacturer should provide the focal point indicated in the EOI with a dossier containing the required information, before a specified date as determined by WHO.

The information should be submitted in the format reflecting the information summarized below. Alternatively, a standard dossier as prepared for or submitted to the DRA can be submitted, provided that it contains the information as required. In such cases, a covering letter cross-referencing the information should be provided by the manufacturer.

The following aspects must be covered:

For innovator products (from manufacturers whose products are manufactured and registered in a country with a stringent drug regulatory authority, including inter alia USA, EU/EEA and Japan):

(a) A WHO-type Certificate of a Pharmaceutical Product2 issued by one of the regulatory authorities of ICH regions together with the summary of product characteristics (SmPC).

2 The WHO type certificate of a Pharmaceutical Product refers to the certificate issued by the international drug regulatory authority in accordance with the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. Further information, and the full text of the WHO document “Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce” can be found in the web site http://www.who.int/medicines/


(b) Assessment report(s) issued by the respective DRA.

(c) WHO-type batch certificate from the manufacturer.

(d) In case the packaging of the product is different from the one approved by the drug regulatory authorities of the ICH regions, then stability testing data should be submitted.

(e) In case the formulation, strength, specifications, etc. are different from the product for which the WHO-type Product Certificate(s) was issued, arguments and/or data to support the applicability of the certificate(s) despite the differences should be submitted.


For multisource (generic products); the data and information to be submitted shall be as described in “Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. A Manual for a Drug Regulatory Authority. Regulatory Support Series, No.5 (WHO/DMP/RGS/98.5). Geneva, World Health Organization, 1999”; including (as summarized below)

(a) Details of the product.

(b) Regulatory situation in other countries.

(c) Active pharmaceutical ingredient(s) (API):

(i) Properties of the active pharmaceutical ingredient(s),

(ii) Sites of manufacture,

(iii) Route(s) of synthesis,

(iv) Specifications: API described in a pharmacopoeia, API not described in a pharmacopoeia,

(v) Stability testing.


(d) Finished product:

(i) Formulation,

(ii) Sites of manufacture,

(iii) Manufacturing procedure,

(iv) Specifications for excipients,

(v) Specifications for the finished product,

(vi) Container/closure system(s) and other packaging,

(vii) Stability testing,

(viii) Container labelling,

(ix) Product information,

(x) Patient information and package inserts,

(xi) Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s),

(xii) Interchange-ability,

(xiii) Summary of pharmacology, toxicology and efficacy of the product.

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