Subsection 5: Labelling of preparations

Without prejudice to the provisions of Article R. 5132-15, the labelling of the immediate packaging and, if available, the outer packaging of the preparations mentioned in 1° to 3° of Article L. 5121-1 must bear, on a white background, the following information, written in such a way as to be easily legible, clearly understandable and indelible:

1° Particulars relating to the identification of the preparation :

a) The name or designation of the preparation, the strength, the pharmaceutical form and, where appropriate, a reference to the recipient ("infants", "children", "adults" or, where appropriate, any other category of patients whose characteristics require special mention) ;

b) The qualitative and quantitative composition in active substances per unit of administration or, depending on the form of administration, for a given volume or mass, using common names where appropriate;

c) Content by mass, volume or units of administration;

d) In the case of a preparation in liquid form, the statements in b and c are replaced by the total quantity of each active substance in the total volume of solution and the concentration in units of mass per volume;

e) Excipients which have a known action or effect. However, in the case of an injectable product, a topical preparation or an eye drop, all the excipients are mentioned;

f) The route of administration if the product is intended to be administered directly to the patient.

For preparations which are not intended to be administered directly to the patient and which are used to make other preparations, the label must include, in a red box and in red lettering, the words: "Not for administration - For pharmacy use only", together with instructions for use;

g) The method of administration, if necessary;

h) The words "Caution - Hypertonic solution" in bold black characters on a light blue background for hypertonic injectable solutions, affixed perpendicular to the other words;

i) When the preparation is intended for a route of administration other than oral, sublingual or perlingual, the label bears the words "Do not swallow" in bold black letters on a red background; for injectable forms that may be administered orally, the words "Do not swallow" may be omitted, provided that the requirements laid down by the good practices applicable to the preparations mentioned in Article L. 5121-5 are complied with.

For injectable solutions packaged in bottles intended to be administered by infusion, the information defined in a and f of this article must be affixed in duplicate and reversed in relation to a horizontal axis.

For injectable solutions packaged in bags intended to be administered by infusion, the information defined in a and f of this article must be affixed in such a way that it can be read when the bags are inserted and administered;

2° Particulars relating to batch number and traceability:

a) The batch number of the preparation made by a pharmacy, an in-house pharmacy or a pharmaceutical establishment. When the preparation is subcontracted under the conditions referred to in Articles L. 5125-1 and L. 5126-2, the batch number is that of the pharmacy, the pharmacy for internal use or the pharmaceutical establishment that prepared the preparation;

b) The registration number of the preparation in the record book or computerised system;

c) The expiry date;

d) Special storage precautions, if any;

e) The name and address of the in-house pharmacy or dispensing pharmacy that prepared and dispensed the preparation or the name and address of the pharmaceutical establishment that prepared the preparation. When the said preparation is made on behalf of an in-house pharmacy or dispensary, the name and address of the in-house pharmacy or dispensary which dispensed the preparation are also mentioned on the label or on a back label.