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New Requirements for Pharmaceutical Quality Personnel

This act amends the educational requirements for individuals responsible for drug quality (Competent Persons and Qualified Persons). The goal is to ensure these individuals possess adequate knowledge and skills, thereby enhancing the safety and quality of medicines available to citizens. Existing qualifications remain valid.
Key points
The list of study fields qualifying for Competent Person and Qualified Person roles in the pharmaceutical industry has been expanded.
A new requirement mandates presenting documents confirming qualification fulfillment by Competent and Qualified Persons.
The Minister of Health will specify the detailed method for confirming qualifications, aiming to standardize the verification process.
Individuals holding these positions before the act's effective date, who met previous requirements, may continue their work.
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61%
VOTING RESULTS
2025-09-12
For 262
Against 0
Abstain 167
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Status:
Enacted
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Additional Information
Print number: 10_1378
Process start date: 2025-06-23
Voting date: 2025-09-12
Meeting no: 40
Voting no: 20