Official Gazette of the Argentine Republic – National Administration of Medicines, Food and Medical Technology

City of Buenos Aires, 08/09/2022

Sr. File No. EX-2022-42167878-APN-DVPS#ANMAT National Drug, Food, and Medical Technology Administration Registry and;

supposing:

The actions cited in the estimate were initiated following the receipt by the market control department ([email protected]) of an email on April 21, 2022 from the technical director of the laboratory GALDERMA ARGENTINA SOCIEDAD ANÓNIMA with a complaint that the product “Apocryphal units of “SCULPTRA VIAL” would be located in the national market.

As a result, OI No. Through 2022/564-DVS-182, the personnel of the Market Control Department were present at the headquarters of GALDERMA ARGENTINA SOCIEDAD ANÓNIMA and on this occasion the technical director of the company explained that, thanks to the sales force, he learned that SCULPTRA products in the national market There are counterfeit units of, Lot A00203, Due 12/2023.

Later, the Technical Authority displayed images of the counterfeit unit and an undisputed original unit of the SCULPTRA product for the purpose of conducting a comparative study, observing the following differences: a) The case of the counterfeit unit indicates “SANOFI AVENTIS”, while the parent units declare “GALDERMA”; 2) the English text is visible on the case and the bottle of the fake units, while the text on the case of the original units is in Spanish and Portuguese (bilingual) and the bottle is in Portuguese; 3) The instructions for use of the counterfeit unit are in English, while the original unit contains instructions for use in Spanish with authorization data in the Republic of Argentina; 4) A QR code is visible on the front and bottom closure flap of the counterfeit case, which is not present in the original units. When this QR code is read, it displays information in oriental language; and 5) the label of the counterfeit vial only details the batch and the expiration date, whereas the original vials contain the batch and the expiration date, as well as the date of manufacture; On the other hand, among the images of suspicious units, we can see a case of “SCULPTRA – 1 x 10 Vial – SANOFI AVENTIS”.

In this regard, the technical manager confirms that the firm GALDERMA ARGENTINA SA does not import units for ten (10) bottles.

Likewise, it was recorded that the technical director of the firm GALDERMA ARGENTINA SA confirmed that lot A00203 was not imported by the firm he represents and, according to Q-Med AB, a construction laboratory based in Sweden , he said that the batch in question is not produced.

For all the above, it has been concluded that the units seen in the images correspond to counterfeit products.

It should be noted that the SCULPTRA bottle product is registered with this national administration by the company GALDERMA ARGENTINA SA, under the medical product number PM 1653-6 and corresponds to risk class IV within the meaning of ANMAT provision number 2318/ 2002, since This product is used to increase the volume of depressed skin areas, correct lipoatrophy and reduce skin aging.

It is an injectable product, so it must meet the requirements of a sterile product.

This is why the existence of counterfeit units on the market potentially represents a high risk for the health of the patients to whom such products can be applied.

From what happened, the Market Control Department understands that the detailed circumstances represent a violation of Law No. 16,463 in that it is an illegitimate product within the meaning of Article 19, paragraph a).

As a result, the Market Control Service of the Directorate of Monitoring, Evaluation and Management of Health Products, suggested restricting the use, marketing and distribution to protect potential buyers and users of the product. in question because they are counterfeit units. NATIONAL ZONE, 1 BOTTLE PER SCULPTRA PRODUCT – LOT A00203 Payable 12/2023 – SANOFI AVENTIS.

That the Directorate has taken over the intervention of its jurisdiction to coordinate the monitoring, evaluation and management and synthesis of health products.

That it operates in the exercise of the powers conferred by Decree No. 1490/92 and its amendments.

So,

National Administrator of the National Drug, Food and Medical Technology Administration

East:

ARTICLE 1.- Use, marketing and distribution on the national territory of the units of the product identified as: SCULPTRA FOR 1 BOTTLE – LOT A00203 Payable 12/2023 – SANOFI AVENTIS PROHIBITED.

Article 2°.- Register. Submit it to the National Directorate of Official Registry for publication in the Official Gazette. Contact the Ministry of Health of the Province of Buenos Aires, the provincial health authorities, the autonomous government of the city of Buenos Aires and the appropriate people. Contact the Health Products Evaluation and Monitoring Management Department. Notify the Technical Information Management Directorate of the ban intended for their purposes. Coordinate compliance summary, its effects.

manual files

I. 08/12/2022 No. 62214/22 V. 08/12/2022

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