Transcription of Packaging ‘blue-box’ requirements and additional ...
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Packaging ‘blue-box’ requirements and additional ...
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).
Legal Status For medicinal products restricted to special prescription (narcotics), a number code assigned by the Minister of Health and a double red line are mandatory.
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