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name, address and telephone number of the main contact for information on the product, clinical trial and emergency unblinding; this may be the sponsor, contract research organisation or investigator (for the purpose of this Annex this is referred to as the ’main contact’);
the name of the substance and its strength or potency, and in the case of blind clinical trials the name of the substance is to appear with the name of the comparator or placebo on the packaging of both the unauthorised investigational medicinal product and the comparator or placebo;
pharmaceutical form, route of administration, quantity of dosage units;
the batch or code number identifying the contents and packaging operation;
a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
the subject identification number and/or the treatment number and, where relevant, the visit number;
the name of the investigator (if not included in (a) or (e));
directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product);
’For clinical trial use only’ or similar wording;
the storage conditions;
period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity; and
’Keep out of reach of children’, except when the product is for use in trials where the product is not taken home by subjects.
name of the main contact;
pharmaceutical form, route of administration (may be excluded for oral solid dose forms), quantity of dosage units and, in the case of clinical trials which do not involve the blinding of the label, the name/identifier and strength/potency;
batch and/or code number identifying the contents and packaging operation;
a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
the subject identification number and/or the treatment number and, where relevant, the visit number; and
period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity.
name of the main contact;
route of administration (may be excluded for oral solid dose forms) and, in the case of clinical trials which do not involve the blinding of the label, the name/identifier and strength/potency;
batch or code number identifying the contents and packaging operation;
a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
the subject identification number/treatment number and, where relevant, the visit number; and
period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity.