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Abstract

FDA: “all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers – or accompanying such article”; labelling is part of the manufacturing process and subject to GMP; reconciliation of the quantities of labels issued, used and returned is necessary; a label representative of those used should be included in the batch production record; see also misbranded drug; labelling of investigational drug samples for clinical trials requires, according to EC guidelines of good clinical practice (III), the following minimal amount of information: “For clinical trial”, name of the responsible physician (investigator), identification-code of the trial, substance or patient code, dosage form, quantity, directions for use, storage conditions, expiry/retest date, producer, contact details (importer if manufacturer is outside the EU), “keep out of reach of children” (if taken home); for clinical trials of medicinal products for use before and during pregnancy: within the EC the following categories for labelling are used: A – product has been assessed, no harmful effects are known; B1 – safety not established, animal studies do not indicate harmful effects; B2 – safety not established, animal studies are insufficient to assess safety; B3 – safety not established, animal studies have shown reproductive toxicity; C – product does not increase spontaneous incidence of birth defects, but has potential hazardous pharmacological effects with respect to the course of pregnancy; D – product is known or suspect to cause birth defects and/or irreversible adverse effects on pregnancy outcome; it may also have potential hazardous pharmacological effects with respect to the course of pregnancy; see also adverse drug experience, blue box requirements, investigational drug labelling, label text, manufacture, pregnancy and lactation labelling.