Article 27-7 and 27-8 of Act on Medicinal Products and Medical Devices No. 362/2011 Col. as amended:
- outer packaging should contain in Slovak language at least:
- the name of the investigational product or its code,
- the method and route of administration,
- the title of a clinical trial or its code,
- the batch number,
- the name or business name and address of the sponsor
- storage conditions,
- expiry date,
- label „VZORKA NA KLINICKÉ SKÚŠANIE" (sample for clinical trial)
B. immediate packaging should contain in Slovak language at least:
- the name of the investigational product or study drug or its code,
- the method and route of administration,
- the batch number,
- expiry date,
- label „VZORKA NA KLINICKÉ SKÚŠANIE" (sample for clinical trial)
For further requirements see Article 26 – 30 and Table I of Annex 13 to EU Guidelines to
Good Manufacturing Practice, Eudralex Vol. IV.:
http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf
