Applicants contribute relevant documentation on Parts 3, 4 and 5 of the WHOPAR and, if required, a Summary of Product Safety and Efficacy to be included in Part 6. Submissions for a multisource product for which no comparator/reference product exists, should include a bibliographic submission.

Documentation to submit for an:

Innovator product, for which a public assessment report has been issued by a Drug Regulatory Authority from the ICH regions or associated countries is available:

• Package Leaflet in English (Part 3),

• Summary of Product Characteristics in English (Part 4),

• Labelling in English (Part 5),

• Summary of Product Safety and Efficacy as contribution to the Discussion (Part 6) may be voluntarily submitted; submission and subsequent publication of this summary ensures availability of product information for all Finished Pharmaceutical Products (FPPs) that are accepted for Prequalification on the Prequalification web site.

Innovator product, for which no public assessment report is available:

• Package Leaflet in English (Part 3)
• Summary of Product Characteristics in English (Part 4)
• Labelling in English (Part 5)
• Summary of Product Safety and Efficacy (contribution to Part 6)

Multisource (generic) product, for which an innovator or comparator/ reference product is available:

• Package Leaflet in English (Part 3)
• Summary of Product Characteristics in English (Part 4)
• Labelling in English (Part 5)

Multisource product, for which an innovator or comparator/reference product is not available:

• Package Leaflet in English (Part 3)
• Summary of Product Characteristics in English (Part 4)
• Labelling in English (Part 5)
• Summary of Product Safety and Efficacy (contribution to Part 6)
• Bibliographic submission containing all literature, original clinical research (if carried out) and other documentation in support of the information provided in the Package Leaflet, Summary of Product Characteristics and Summary of Product Safety and Efficacy in the Discussion.

Format of documentation

• The format of the Package Leaflet (Part 3), Summary of Product Characteristics (Part 4) and Labelling (Part 5) should follow the format for such documents as described in Appendix 3.

WHOPAR GUIDANCE for APPLICANTS (MANUFACTURERS) v 1.0

• The format of the Summary of Product Safety and Efficacy as contribution to the Discussion (Part 6) is described in Appendix 4.

• Bibliographic submission

For multisource products for which an innovator or comparator/reference product is not available e.g. products containing a new combination of active ingredients like FDC's or are traditionally used multisource products such as the artemisinines, full information on safety and efficacy as defined in guidelines of the European Union (Commission and EMEA), Japanese Ministry of Health, Labour and Welfare (MHLW) and the US Food and Drug Administration (FDA) must be submitted in a bibliographic submission¹³. A bibliographic submission should contain all relevant scientific literature, in the case of FDC's including evidence on the safety and efficacy of the equivalent combination of single API products, original clinical research (if carried out) and other documentation in support of the information provided in the Package Leaflet, Summary of Product Characteristics and Summary of Product Safety and Efficacy in the Discussion. The format for presentation of information and data should follow the manual 'Marketing Authorization of Pharmaceutical Products with special Reference to Multisource (Generic) Products: a Manual for a Drug Regulatory Authority¹⁴. Further useful guidance is provided in the draft WHO "Guidelines for Registration of Fixed Dose Combination Medicinal Products¹⁵ of September 2004 e.g. attachment 2, "Principles for determining whether data from scientific literature are acceptable". Information, especially with respect to submissions according to the format of the Common Technical Document (CTD) can be found at the website of the International Conference on Harmonization (ICH)¹⁶ as well as on those of the ICH Regulatory Bodies: EU (Commission¹⁷ and EMEA¹⁸), Japan (MHLW¹⁹) and USA (FDA²⁰).

¹³http://mednet3.who.int/prequal/hiv/generichiv.pdf

¹⁴http://www.who.int/medicines/library/qsm/manual-on-marketing/who-dmp-rgs-985.doc

¹⁵http://www.who.int/medicines/organization/qsm/expertcommittee/Guidelines/FDC-WHO-QAS04108.doc

¹⁶http://www.ich.org/

¹⁷http://pharmacos.eudra.org/F2/home.html

¹⁸http://www.emea.eu.int/

¹⁹http://www.mhlw.go.jp/english/

²⁰http://www.fda.gov/