(2003; 148 pages)
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:
(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),
(xiii) Summary of pharmacology, toxicology and efficacy of the product.