KLSH: Both Botox and filler entered Albania 'secretly' from South Korea

The High State Control, in an audit at the Customs Directorate, found 51 customs declarations with filler and botox products, declared in the article code "Other".

These products are reported by KLSH, have been cleared and passed for trading without the relevant approvals for both the manufacturer and the trader, since in Albania there is no active license for the trading and use of these products.

KLSH indicates that due to the lack of nomenclature code for this product, Customs have registered it under code 3304 99 00, in the group of "other" goods.

From the audit, it was found that for these products there is no specific risk profile in the system, resulting in an increased risk from non-control for misdeclarations, misclassifications and lack of special documentation for trading permission.

"Misdeclaration and misclassification of the article is suspected. It is suspected that there are injectable items (botox, lip filler, etc.) in the body (skin, lips) and as such, registration with the AKBPM is required. Misdeclaration and misclassification by the declarant is carried out in order to avoid customs controls"

The origin of these products in 75% of cases is South Korea, and the KLSH has asked the DPD for laboratory analysis and physical verification of the articles on the grounds that "Misdeclaration and misclassification of the article is suspected. It is suspected that there are injectable items (botox, lip filler, etc.) in the body (skin, lips) and as such, registration with the AKBPM is required. Misdeclaration and misclassification by the declarant is carried out in order to avoid customs controls"

KLSH estimates that under the "other" code, about 8 billion ALL items have been cleared, but it is not specified how many of these are injectable substances.

KLSH emphasizes that these products are of small weight and high value, but as it has been evidenced, the declared value turns out to have deviations.

The customs control structures have not carried out physical checks for these products in order to identify irregularities.

The audit for these products belongs to the period 2021-2023.

The HSC report was published a few weeks after a police operation raided 30 aesthetic clinics in the country for smuggling the Botox product. The well-known aesthetic doctor, Skerdi Faria, is still wanted.

In an official communication to the media at the time, the National Agency of Medicines stated that there was no request for the use of this product and therefore no permit or stamp was issued for its use.

"Botulinum Toxin is not an authorized drug for trade in the Republic of Albania as there have been no requests for its registration by the Holders of the Trade Authorization. Consequently, for this drug, the Agency has not issued an import permit/customs clearance/use permit or control stamp for any pharmaceutical subject", the Agency's statement/  Gazetasi said.