Title II: Medicinal products for human use

A sample shall give rise, on the spot, to the drafting of : – as part of an inspection carried out under the conditions laid down in articles L. 1421-1 to L. 1421-3, article L. 5127-2 or article L. 5313-3, a report ; – as part of a procedure to investigate and establish criminal offences under the conditions set out in article L. 5412-1 or articles L. 5411-1 to L….

The report or minutes shall include the following information: 1° The surname, forenames, capacity and place of residence of the officer or officers who drew up the report or official report; 2° The date, time and place where the sample was taken; 3° The surname, first name, profession, domicile or residence of the person from whom the sample was taken; if the sample was taken during transport, the name and…

The report or record : 1° Contains a brief description of the circumstances in which the sample was taken ; 2° Relates : a) The marks and labels affixed to the primary or outer packaging ; b) The size of the batch of products sampled; c) Any information deemed useful for establishing the authenticity of the samples taken; d) The identity of the product and the exact name under which…

The owner or holder of the product or, where applicable, the representative of the transport company may include in the report or minutes any statements that he or she considers relevant. The owner or holder will be asked to sign the report; if he refuses, the officer(s) who drew up the report will make a note of this.

Samples are taken in such a way that the three samples are, as far as possible, identical. The necessary measures are taken to ensure that samples are transported under conditions that guarantee their proper preservation and integrity.

The samples taken are sealed. These seals are applied to a label containing the following information in particular: 1° The name of the product ; 2° The category to which the product belongs, with reference to those mentioned in article L. 5311-1 ; 3° The name and address of the owner or holder of the product; 4° The date of sampling; 5° The serial number of the sample; 6° The…

Samples taken do not give rise to any payment by the State or, as the case may be, the Agence nationale de sécurité du médicament et des produits de santé or the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. A copy of the report or record of sampling is given to the owner or holder of the product.

One of the samples is left with the owner or holder of the product. If the interested party refuses to keep the said sample on deposit, this refusal will be mentioned in the report or the minutes. Under no circumstances shall the person concerned alter the condition of the sample entrusted to him.

When, because of the quality or quantity of a product, it is impossible to divide it into three samples, the official taking the sample shall seal the entire product in a single sample.

A copy of the report or record of sampling shall be sent by its author(s), as appropriate, to the Director General of the Agence nationale de sécurité du médicament et des produits de santé or to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The Agency will immediately inform the officials who drafted the report or the minutes whether it is…