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Active Ingredient: DGT doctrinal evolution

How the DGT's position on this topic has evolved, and the rulings it rests on.

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How the DGT's position has evolved

Settled doctrine High confidence 9 rulings · 2015–2026

Current position

The import or intra-Community acquisition of packaging containing active ingredients may qualify for the exemption under Article 75 of Law 7/2022 if they are intended exclusively for the manufacture of medicinal products under Good Manufacturing Practice standards. This exemption does not apply to packaging containing excipients or intermediate products due to their lack of pharmacological action or having other uses. In manufacturing operations, if the active ingredient provided by the customer is not insignificant, the operation is classified as a provision of services.

The DGT's position remains stable regarding the distinction between active ingredients and excipients for the application of exemptions. A specialization is observed in the treatment of packaging containing active ingredients under Law 7/2022. Likewise, the criterion of classifying an operation as a provision of services persists when the active ingredient provided by the customer has a relevant weight in the final product.

Turning points

  1. V1038-23

    Establishes that the exemption is not applicable to packaging with excipients due to their lack of pharmacological action.

  2. V2380-23

    Reinforces that the exemption requires exclusive destination for the manufacture of medicinal products, excluding intermediate products.

Analysis based on 9 of 9 rulings with a stated position. Updated 28 September 2026.

Rulings on this topic

9
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