4.

When the product is provided to the subject or the person administering the medicinal product in an immediate packaging and outer packaging intended to remain together, and the outer packaging carries the particulars listed in section A.1., the following particulars shall appear on the immediate packaging (or any sealed dosing device that contains the immediate package): 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.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.