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Packaging ‘blue-box’ requirements and additional ...

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 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) .. 5 CYPRUS (CY) .. 6 CZECH REPUBLIC (CZ) .. 7 DENMARK (DK) .. 9 ESTONIA (EE) .. 10 FINLAND (FI) .. 11 FRANCE (FR) .. 12 GERMANY (DE) .. 13 GREECE (EL) .. 14 HUNGARY (HU) .. 15 ICELAND (IS) .. 16 IRELAND (IE) .. 17 ITALY (IT) .. 18 LATVIA (LV) .. 20 LIECHTENSTEIN (LI) .. 21 LITHUANIA (LT) .. 22 LUXEMBOURG (LU) .. 23 MALTA (MT) .. 24 NETHERLANDS (THE) (NL) .. 25 NORWAY (NO) .. 26 POLAND (PL) .. 27 PORTUGAL (PT).

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

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