08.08.2024
Changes in pharmaceutical product import declarations effective from 1 July 2024
As of 1 July 2024, significant changes have been implemented regarding the declaration of pharmaceutical products (medicines) and active substances for import. From this date, you are required to always include a (fictitious) document code in your declaration. This new requirement extends to veterinary pharmaceuticals as defined in Article 4, Section 1, of Regulation (EU) 2019/6.
Required document codes
- Marketing Authorisation: If you have a marketing or manufacturer license for importing pharmaceutical products into the Netherlands (in accordance with Article 18 of the Medicines Act), you must include document code 1400 in your declaration from 1 July 2024.
- API registration: If you have an API registration for the release of active substances into free circulation (in accordance with Article 38 of the Medicines Act), you must include document code 1450 in your declaration.
- Non-medicines act goods: If you are releasing goods into free circulation that do not fall under the Medicines Act but are classified under a similar category in the Tariff Manual (Gebruikstarief), you must include the fictitious document code 1499 in your declaration. This code indicates that these goods do not fall under the Medicines Act and do not need to meet its requirements.
To successfully complete your import declaration, one of these document codes must be entered. Failure to include the appropriate code will result in your declaration being rejected.
