S.L. 458.62 · Authorisation For Preparation And (S.L. 458.62)
S.L. 458.62 Art. 10Labelling requirements.
(1) Each dispensed medicinal product must be properly and adequately labelled.
(2) The label must include:
(a) active pharmaceutical ingredient;
(b) pharmaceutical form;
(c) administration route;
(d) pharmaceutical dose;
(e) batch number; and
(f) expiry date:
Provided that the Central Procurement and Supplies Unit
(CPSU) may add further information that it may deem necessary from time to time.
(3) The labels must be in an indelible ink, in a format and font which can be easily read by a person with a healthy unaided eyesight without using any reading enabling devices or instruments.