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21 May 2014 EMA/334808/2014 Compliance and Inspections Department Qualified Persons declaration concerning GMP compliance of the active substance manufacture The UP declaration template Reference

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What is qualified persons declaration concerning?

Qualified persons declaration concerns the verification of certain qualifications or credentials.

Who is required to file qualified persons declaration concerning?

Qualified persons who are responsible for certain tasks or decisions may be required to file a declaration.

How to fill out qualified persons declaration concerning?

Qualified persons can fill out the declaration by providing accurate and complete information about their qualifications and credentials.

What is the purpose of qualified persons declaration concerning?

The purpose of the declaration is to ensure that individuals in key roles possess the necessary qualifications to perform their duties.

What information must be reported on qualified persons declaration concerning?

Information such as educational background, certifications, and relevant experience may need to be reported on the declaration.

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