As the European Union prepares to revise its Good Distribution Practice (GDP) Guidelines, GIRP, the European Healthcare Distribution Association, launches today its front-running position paper setting out key priorities of the sector.GIRP suggests that the new GDP Delegated Regulation should be guided by the following overarching principles:
1. Risk‑based approach as a key principle. The new GDP Delegated Regulation should establish an overarching risk-based approach, enabling both authorities and operators to focus on activities with the greatest impact on maintaining the quality and integrity of medicinal products for human use during distribution and thereby patient safety.
2. Legal clarity and consistency. Clear and consistent terminology is essential to ensure legal certainty and harmonised implementation across the EU. It should also be used throughout the text to avoid overly divergent interpretations and translation issues.
3. Avoidance of duplication and re-statements.
4. Proportionate requirements without extra costs
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