A.2.2. Small immediate packaging

If the immediate packaging takes the form of blister packs or small units such as ampoules on which the particulars required in section A.1. cannot be displayed, the outer packaging provided shall bear a label with those particulars. The immediate packaging shall contain the following: 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.

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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.