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Article R5121-138-2 of the French Public Health Code

I.-The outer packaging or, where there is no outer packaging, the immediate packaging of medicinal products bears safety features consisting of a unique identifier and a tamper-evident device, under the conditions set out in articles R. 5121-138-1 and R. 5121-138-3.

II.-The unique identifier allows persons whose activity is the wholesale distribution of medicinal products or the retail dispensing of medicinal products:

1° To verify the authenticity of the medicinal product;

2° To identify individual boxes of medicinal products.

III -The tamper-evident device enables the integrity of the outer packaging of the medicinal product to be verified.

Original in French 🇫🇷
Article R5121-138-2

I.-Le conditionnement extérieur ou, à défaut de conditionnement extérieur, le conditionnement primaire des médicaments porte des dispositifs de sécurité consistant en un identifiant unique et un dispositif antieffraction, dans les conditions prévues aux articles R. 5121-138-1 et R. 5121-138-3.


II.-L’identifiant unique permet aux personnes dont l’activité est la distribution en gros de médicaments ou la dispensation au détail de médicaments :


1° De vérifier l’authenticité du médicament ;


2° D’identifier les boîtes individuelles de médicaments.


III.-Le dispositif antieffraction permet de vérifier l’intégrité du conditionnement extérieur du médicament.

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