PPWR Scope Check

The PPWR (Regulation (EU) 2025/40) has applied to all packaging on the EU market since August 12, 2026. The widely cited safety exemption in Art. 6(11) covers the immediate packaging, the outer packaging only where it is necessary to preserve the quality of the medicinal product, and only the recyclability requirements of Article 6. This check maps your packaging levels onto the four families of obligations.

Question 1 of 4

Do you place packaging on the EU market, or have it placed on the market on your behalf?

As manufacturer, importer, authorized representative or fulfillment service provider. The PPWR attaches to the packaging, not to the industry.

Orientation only, not a substitute for a regulatory assessment.

Image notice: The images on this page were generated using artificial intelligence. They do not depict real people, places, or events.

PPWR: Why Pharma Packaging Is Not Exempt

"Pharma is exempt from PPWR" is only partly true. The Article 6(11) exemption covers primary packaging, and cartons only where they preserve product quality. The rest is in scope. General application: August 12, 2026.

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