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812.21 HMGLPTHLATER CH

Art. 6 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Conditions

TPA; Chapter 2 Medicinal Products
Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

Art. 6 TPA · Conditions

The licence shall be issued if: a. the necessary technical and operational conditions are fulfilled; b. an appropriate system of quality assurance exists.

The competent authority shall verify by inspection that the conditions are fulfilled.

← Art. 5 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 7 TPA →

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Court Decisions Applying This Provision (1)

JAAC 70.22 (Art. 6 HMG)
Manufacturer Denied License Modification Due to Unsuitable Technical Manager
The court considered that the applicant did not fulfill the personal requirements for a manufacturing authorization, specifically those related to the responsible person, as mandated by this article.