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Cover letter template for notification of "withdrawn products" by marketing authorisation holders (< FROM MAH ON HEADED PAPER >) <Date> Name of regulatory authority, Address RE: Notification of "withdrawn product” Dear <Name>, Please find herewith enclosed our notification for a Centrally authorised medicinal product in accordance with Article 13 and 14b of Regulation 1027/2012 Nationally Authorised medicinal product in accordance with Article 23a and 123 of Directive 2012/26/EC <Product Name(s)>, <INN(s)>, <MAH>, <EVCODE> To take the following action(s): Cease the marketing of a medicinal product (permanently or temporarily) Suspend the marketing of a medicinal product Withdraw a medicinal product from the market Request the withdrawal of a marketing authorisation Not to apply for the renewal of a marketing authorisation I declare that the reason(s) for such action(s) are: Based on the grounds provided in Articles 116 and 117 of Directive 2001/83/EC; Not based on the grounds provided in Articles 116 and 117 of Directive 2001/83/EC. I herewith confirm that together with this cover letter an Excel spread sheet (template EMA/445787/2013) entitled <MAH file name> is submitted containing all the required information related to the medicinal product(s) concerned. Yours sincerely, <Signature of authorised contact person> <MAH> cc: <PTL for centrally authorised medicinal product> <Rapporteur> <Co-Rapporteur> Encl(s) <Number> Excel file