Transcription of Packaging ‘blue-box’ requirements and additional ...
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cmdv -GUI-27. EMA/ cmdv /391895/2012. Version 22/12/2014. Packaging blue -box' requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures additional information on labelling/package leaflet that may be required or permitted nationally in accordance with Articles 58 and 64 of Directive 2001/82/EC, as amended, is outlined below. Index AUSTRIA (AT) .. 2. BELGIUM (BE).. 3. BULGARIA (BG) .. 4. CROATIA (HR).
CMDv GUI-027 _ addition CP EMA/CMDv/391895/2012 Page 1 of 35 . CMDv-GUI-27 . EMA/CMDv/391895/2012 . Version 22/12/2014 . Packaging ‘blue-box’ requirements and additional information …
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