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Commission Regulation (EC) No 1234/2008 of 24 of November 2008, concerning the examination of variations to the terms of marketing authorisations for In addition, the Annex to these guidelines provides details of the classification of variations into the following categories as defined in Article 2 of the Variations
A list of ECB Working paper series is provided disseminating economic research relevant to the various tasks and functions of the ECB.
Consequently, this guideline provides details of the classification of variations into the following categories as defined in Article 2 of the variations regulation: minor variations of. Type IA, minor variations of Type IB and major variations of Type II and provides further details, where appropriate, on the scientific data to be
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Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure - superseded, (English only), 2015-05-18 existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system, (English only), adopted, 2011-03-02, 2013-08-02.
In-depth studies for experts. Our Working Paper Series (WPS) disseminates economic research relevant to the various tasks and functions of the ECB, and provides a conceptual and empirical basis for policy-making. The Working Papers constitute “work in progress”. They are published to stimulate discussion and
     

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