Labelling requirements for Investigational Medicinal Product

Article 16d Act on medicinal products and medical devices No. 140/1998 Col. as amended:

• A. 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

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