Documents showing the capacity of the Transferee to perform all the responsibilities required of a MAH under Union pharmaceutical legislation:.Proof of establishment of the Transferee within the European Economic Area (EEA), issued in accordance with national provisions and dated within the last six months.(See also “How to choose the implementation date?”) The transitional period between the notification of the Commission decision on the transfer of a marketing authorisation and the implementation date should be proportionate to the organisational activities that need to be performed by the Transferor and Transferee. This is referred to as the ‘implementation date’. A document stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements.A document certifying that the complete and up-to-date file concerning the medicinal product or a copy of this file has been made available to or has been transferred to the Transferee.The identifications (name, address and email) of the Transferor and the Transferee.The name of the medicinal product concerned by the authorisation transfer, the authorisation number(s) and the date(s) on which the authorisation(s) was (were) granted.Transfer applications should be accompanied by a cover letter and be presented as follows: Commission Regulation (EU) No 712/2012 amending Regulation (EC) No 1234/2008.Commission Regulation (EC) No 1234/2008.Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for centralised medicinal product falling within the scope of Council Regulation (EC) No 2309/93.the person/company to whom the transfer is to be granted is termed the Transferee.
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