Annex 13 Labeling Requirements For The EU

Labeling should comply with the requirements of Directive 2003/94/EC.

The following information should be included on labels, unless its absence can be justified, e.g. use of a centralised randomization system:

a) Name, address and telephone number of the sponsor, contract research organization or investigator  (the main contact for information on the product, clinical trial and emergency unblinding);
b) pharmaceutical dosage form, routeof administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/potency;
c) the batchand/or code number to identify the contents and packaging operation;
d) A trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
e) the trial subject identification number /treatment number and where relevant, the visit number;
f) the name of the investigator (if not included in (a) or (d);
g) directions for use (reference may be made to a leaflet or other explanatory document intended for the trial subject or person administering the product);
h) “For clinical trial use only” or similar wording;
i) the storage conditions;
j) period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity; and
k) “Keep out of reach of children”, except when the product is for use in trials where the product is not taken home by subjects