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New qualification rules for pharmaceutical production

The act changes educational requirements for key personnel in pharmaceutical companies. It concerns the Qualified Person and Responsible Person, who ensure the quality and safety of manufactured medicines.
Key points
Broader list of university degrees qualifying for Qualified and Responsible Person roles – includes biomedical engineering, chemistry, biotechnology, veterinary medicine.
Mandatory submission of documents proving education – the minister will specify detailed rules.
Current post holders retain the right to continue performing these duties.
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61%
VOTING RESULTS
2025-09-12
For 262
Against 0
Abstain 167
Full voting results open_in_new
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Status:
Became Law
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Additional Information
Rządowy projekt ustawy o zmianie ustawy - Prawo farmaceutyczne.
Print number: PROJEKT USTAWY 1378
Process start date: 2025-06-23
Voting date: 2025-09-12
Voting no: 20