Detect risks on active substances of drugs without registration in customs declarations

Customs

This algorithm helps Customs select goods for inspection based on customs declarations and risks. It uses declaration data from companies and considers whether or not there are increased risks of compliance with the registration requirement for importing active substances for making medicines.

Last change on 9th of December 2024, at 14:10 (CET) | Publication Standard 1.0

• Publication category: Impactful algorithms
• Impact assessment: Field not filled in.
• Status: In use

General information

Theme

Health and Healthcare

Begin date

03-2014

Contact information

[e-mail]

Link to publication website

https://www.belastingdienst.nl/bibliotheek/handboeken/html/boeken/HVGEM/geneesmiddelen.html

Responsible use

Goal and impact

The purpose of this algorithm is to more efficiently select which declarations may be subject to registration under the Medicines Act. This algorithm focuses on imports of active substances for making medicines and looks at declarations of goods entering the territory of the Netherlands from outside the European Union. It indicates which declarations are subject to a registration requirement for active substances for making medicines. Customs checks companies more or less based on the results. By using this algorithm, declarations are processed more efficiently, resulting in declarations being checked more quickly and possibly released more quickly.

Considerations

Customs processes 700 million declarations annually, including in the field of active substances. With this algorithm (risk profiles), Customs can assess declarations more efficiently and faster than without using this algorithm. Thus, declarations are approved or checked faster. And goods are released faster. Also, the algorithm ensures that 'known and reliable' companies are actually checked less.

Human intervention

If a declaration yields a match with a risk profile, a customs officer reviews the declaration. And asks for more information if necessary. The decision to approve a declaration, or to start checking it, is taken by a human being.

Risk management

A risk profile is always developed and checked by at least two customs staff before use. This is the 4-eye principle. And once the profile is in use, a weekly check is made for a profile to see how many declarations produce a match. If necessary, the profile can be adjusted. Periodically, Customs checks per profile whether it is still necessary to refine, extend or terminate it. Customs monitors internal and external complaints and incidents, for example if a profile is insufficiently specific and therefore designates too many declarations as higher risk.

Legal basis

Legal basis for active substance control lies in the Union Customs Code (DWU), the General Customs Act and the Medicines Act. These laws ensure that imports of active substances take place properly. The use of risk profiles also relies on DWU Article 46. That article says customs controls must rely primarily on risk analysis by electronic data processing techniques.

Links to legal bases

• https://wetten.overheid.nl/BWBR0021505/2024-01-01 : Geneesmiddelenwet
• https://eur-lex.europa.eu/legal-content/NL/TXT/PDF/?uri=celex:32013R0952: Douanewetboek van de Europese Unie

Operations

Data

The algorithm uses data from the goods declaration. For example, type of goods, commodity code, document code, weight, number of packages, consignee, declarant, consignor, country of consignment, EORI number, means of transport, etc.

Links to data sources

https://www.belastingdienst.nl/wps/wcm/connect/bldcontentnl/belastingdienst/douane_voor_bedrijven/naslagwerken_en_overige_informatie/andere_onderwerpen/gegevensvereisten/: Gegevensvereisten douaneaangiften (zie Bijlage B Gedelegeerde Verordening Douanewetboek van de Europese Unie + Bijlage VIa van de Algemene Douaneregeling)

Technical design

The algorithm consists of decision rules created in collaboration with content experts. These decision rules provide estimates of which declarations have a higher risk of importing active substances for making drugs without registration. These decision rules are based on 'if-then-else' combinations. An example: if (if) the information we have on a shipment shows that the goods have an abnormal weight, (then) we manually check the declaration and the shipment may be selected for extended inspection. If the goods do not have an abnormal weight (else), we do not stop the shipment. Or at least not based on this criterion.

External provider

Internally developed