Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009 Generics approved by stringent regulatory authorities: what and how? Dr Lembit Rägo, Coordinator Quality Assurance and Safety: Medicines (QSM) Department of Essential Medicines and Pharmaceutical Policies (EMP) Geneva, Switzerland

Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009

A. Prequalification applications 1. Applicants should submit the following documentation:  A letter of undertaking (template attached) with a clear statement by the responsible person that the information submitted is true and correct.  A QA-certified copy2 of the Marketing Authorization issued by the relevant SRA.  A QA-certified copy2 of the Manufacturing Authorization issued by the relevant SRA.  An original or certified copy of WHO-type Certificate of a Pharmaceutical Product issued and fully completed, including answers to each question, by one of the SRAs, together with the approved Summary of Product Characteristics (SPC), or an equivalent thereof, including Patient Information Leaflet (PIL) and Labelling.  Assessment report(s) issued by the relevant SRA.

Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009 Continued  2. Evidence of minimum five (5) years of current and continuous manufacturing experience and a copy of the last Annual Product Report.  A sample of the FPP(s) in market packing should be provided to enable visual inspection of the FPP(s). Attach certificate of analysis.  Please note submission must be in English which includes authorized English translations of SPCs and other documents.

Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009 B. Simplified prequalification applications for anti-malarial and anti-tuberculosis FPPs  The applicant shall not be required to provide the SRA assessment report, if the Applicant can demonstrate that the API(s) of the FPP have a well established medicinal use, with recognized efficacy and an acceptable level of safety, by means of a detailed scientific bibliographical or expert evidence to the effect that the FPP in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the ICH regions.  All the other, above-listed documents and a sample in market packing should be submitted with the Application.  References: Information and the full text of the relevant WHO documents can be found in the website

Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009 Definition of SRA  Stringent Drug Regulatory Authority (SRA) means a regulatory authority (in case of the European Union both EMEA and national competent authorities are included) which is  a) a member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH (as specified on its website:);  or (b) an ICH Observer, being the European Free Trade Association (EFTA) as represented by SwissMedic, Health Canada and World Health Organization (WHO) (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement including Australia, Norway, Iceland and Liechtenstein (as may be updated from time to time).

Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009 B. Undertaking  a) authorizes WHO to publish on the WHO prequalification web site the information as listed in points 2 to 6 and 11 to 14 of the "Main characteristics of the prequalified medicinal product";  b) Will inform the WHO Prequalification Programme in writing of any variations approved by the relevant SRA in the manufacture of, including in particular (but not limited to) those specified in the "Main characteristics of the prequalified medicinal product", according to Guidance on variations to a prequalified product dossier. Geneva, World Health Organization, 2007, Annex 6 (WHO Technical Report Series, No. 943);  c) has nominated a responsible employee (as detailed below) in responsible for communication with WHO on any issues, including quality failures and safety concerns, related to the and will inform WHO of any change of contact person:

Meeting for EU Generic Manufacturers and EU MA holders for generic medicines, Copenhagen, 26 November 2009 Concluding remarks  … please look PQP web site for more information and updates  There is an opportunity to help with supplies to achieve MDGs and have a market opportunity for EU generic manufacturers  We are looking forward for more cooperation with EGA and individual companies