Labelling requirements for Investigational Medicinal Product

Článok

• Zverejnené: 10.08.2010
• Posledná zmena: 20.03.2026

Obsah

Article 27-7 and 27-8 of Act on Medicinal Products and Medical Devices No. 362/2011 Col. as amended:

1. 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