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The Netherlands | Customs

July 08, 2024

Dutch Customs: Genuine Mistakes no longer lead to Criminal Prosecution, Import of Medicines Requires Specific Details

Changes in Dutch Customs Regulations

Dutch Customs: Genuine Mistakes no longer lead to Criminal Prosecution, Import of Medicines Requires Specific Details

GENUINE MISTAKES IN CUSTOMS DECLARATIONS: FINES INSTEAD OF PROSECUTION

If you are involved in importing or exporting goods, recent changes in Dutch customs regulations mean that genuine mistakes or incomplete declarations in your customs documents will no longer lead to criminal prosecution. Instead, you will face a fine. This change also applies if you fail to submit your customs declaration or submit it late. The maximum fine for such infractions is €1,377.

Moreover, if the declared amount is significantly understated, the maximum fine can reach €5,514. Additionally, the period within which these fines can be imposed has been reduced from five to three years.

The new law came into effect on July 1, 2024.

CHANGES TO IMPORT DECLARATIONS FOR MEDICINES STARTING JULY 1

Starting July 1, 2024, new requirements apply to the declaration of pharmaceutical products (medicines) and active substances for import. Every import declaration must now include a specific (fictitious) document code. This requirement also extends to veterinary pharmaceuticals as outlined in Article 4, Section 1, of Regulation (EU) 2019/6.

REQUIRED DOCUMENT CODES:

Marketing Authorisation:

If you have a marketing authorisation for importing pharmaceutical products into the Netherlands (according to Article 18 of the Medicines Act), include document code 1400 in your declaration.

API Registration:

If you have an API registration for the release of active substances into free circulation (according to Article 38 of the Medicines Act), include document code 1450 in your declaration.

Other Goods:

For goods not covered under the Medicines Act but classified under a similar category in the Tariff Manual (Gebruikstarief), include document code 1499 in your declaration. This code indicates that the goods do not fall under the Medicines Act and do not need to meet its requirements.

If you fail to include the appropriate document code, your import declaration will not be accepted.

Note: The authorisation holder must be the first recipient where the pharmaceutical products or active substances are delivered.

CONDITIONS:

Pharmaceutical Products:

  • Measure: Pharmaceutical products
  • Effective from: July 1, 2024
  • Geographical area: 1011
  • Document codes for import declarations:

 

Code

Type of Document

Description

Procedure

1400

National (fictitious) document

The importer indicates that the first recipient holds a marketing authorisation under the Medicines Act (Article 18 of the Medicines Act).

24: Released for free circulation

1499

National (fictitious) document

The stated goods do not fall under the provisions of the Medicines Act.

24: Released for free circulation

-

No required document submitted

-

04: Release for free circulation is not allowed

 

Active Substances of Pharmaceutical Products (Medicines):

  • Measure: Pharmaceutical products
  • Effective from: July 1, 2024
  • Geographical area: 1011
  • Document codes for import declarations:

 

Code

Type of Document

Description

Procedure

1450

National (fictitious) document

The importer indicates that the first recipient possesses a registration to import active pharmaceutical ingredients into the Netherlands under the Medicines Act (Article 38 of the Medicines Act).

24: Released for free circulation

1499

National (fictitious) document

The stated goods do not fall under the provisions of the Medicines Act.

24: Released for free circulation

-

No required document submitted

-

04: Release for free circulation is not allowed

 

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