French Public Health Code
In forceThe outer packaging of medicinal products covered by this section shall include :
1° If the medicinal product is intended for humans, a white space, surrounded by a coloured line, in which the dispensing pharmacist or doctor writes the prescribed dosage; if it is a medicinal product classified as a narcotic or subject to narcotic regulations, the dispensing pharmacist or doctor also writes his name, address and the reference number provided for in article R. 5132-10 ;
2° If it is intended for an animal, a white space, surrounded by a coloured line, in which the dispensing pharmacist or veterinarian enters the prescribed dosage as well as the statement provided for in 12° of article R. 5141-73 in black lettering on a red background. In the case of a medicinal product classified as a narcotic or subject to narcotic regulations, the dispensing pharmacist or veterinarian also enters his name, address and the reference number provided for in article R. 5141-112.
The white space is large enough to allow the required information to be affixed; it is placed under the special name of the pharmaceutical speciality or product.
The labelling of the container and the packaging of the medicinal products referred to in the first paragraph must show legibly :
a) For veterinary medicinal products, the words "Respect the prescribed doses" in black lettering on a red background and "Only on prescription" printed in black lettering and, when the medicinal product is intended for a route of administration other than oral, sublingual, perlingual and injectable, "Do not allow to be swallowed" in black lettering on a red background ;
b) For medicinal products for human use, with the exception of magistral and hospital preparations mentioned in 1° and 2° of Article L. 5121-1 of the Public Health Code and used to make other preparations, the words "Respect the prescribed doses" in black lettering on a red background, "Only on prescription" in black lettering and, when the medicinal product is intended for a route of administration other than oral, sublingual, perlingual or injectable, "Do not swallow" in black lettering on a red background.
For magistral and hospital preparations which are not intended to be administered directly to the patient and which are used to make other preparations, the words "Only on prescription" in black lettering.
When the medicinal products are contained in an outer packaging that complies with the provisions of this article :
1° The words "On prescription only" are not compulsory for immediate packaging containing only one dose for use;
2° The words "Respect the prescribed doses" are not compulsory for ampoules or other small primary packagings for which the affixing of these words would not allow optimum legibility of the information provided for in article R. 5121-142 and article R. 5141-74.
