Changes to Import declarations for medicines starting 1 July
18.06.2024
Starting 1 July 2024, there will be changes to how you declare pharmaceutical products (medicines) and active substances for import. From this date, you must always include a (fictitious) document code in your declaration. This new requirement also applies to veterinary pharmaceuticals as defined in Article 4, Section 1, of Regulation (EU) 2019/6.
The following document codes are required:
- Do you have a marketing authorisation for importing pharmaceutical products into the Netherlands (according to Article 18 of the Medicines Act)? Then from 1 July 2024, you must include document code 1400 in your declaration.
- Do you have an API registration for the release of active substances into free circulation (according to Article 38 of the Medicines Act)? Then you must include document code 1450 in your declaration.
- Are you 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)? Then you must include the fictitious document code 1499 in your declaration. This indicates that these goods do not fall under the Medicines Act and do not need to meet its requirements.
To complete your import declaration, you must enter one of the document codes. If you do not do this, your declaration will not be accepted.
Please note!
The authorisation holder must be the first recipient where the pharmaceutical products or active substances are delivered.
Conditions
Pharmaceutical products
NLINVG: Measure 'Pharmaceutical products'Effective from: 1 July 2024
Geographical area: 1011
| C: | Submission of a Certificate/Authorisation/Document | ||
|---|---|---|---|
| Code | Type of document | Description | Procedure |
| 1400 | National (fictitious) document | The importer indicates that the first addressee/recipient holds a marketing authorisation to market pharmaceuticals in the Netherlands 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)
NLINVG: Measure ‘Pharmaceutical products'Effective from: 1 July 2024
Geographical area: 1011
| C: | Submission of a Certificate/Authorisation/Document | ||
|---|---|---|---|
| Code | Type of document | Description | Procedure |
| 1450 | National (fictitious) document | The importer indicates that the first addressee/recipient possesses a registration to import active pharmaceutical ingredients into the Netherlands falling 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 | ||
