812.21
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Art. 62 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Data confidentiality
TPA; Chapter 4 Common Provisions on Medicinal Products and Medical Devices
Art. 62 TPA · Data confidentiality
If there is an overriding legitimate interest in preserving the secrecy of the data collected in accordance with this Act, the competent authority must treat such data as confidential.
The Federal Council may determine the data which are disclosed by the competent authority.
Court Decisions Applying This Provision (4)
A-3621/2014 (Art. 62 LPTh)
Pharmaceutical Product Approval Document Access Dispute
The court discussed whether this provision constitutes a special clause under the LTrans.
C-8797/2007 (Art. 62 Abs. 1 HMG)
Generic Drug Manufacturer's Standing in Marketing Exclusivity Dispute
Cited in relation to protecting confidentiality interests when communicating decisions.
JAAC 68.169 (Art. 62 al. 1 LPTh)
Access to External Expert Reports vs. Anonymity of Experts in Drug Approval
This provision allows for restrictions on the right to inspect files when essential public or private interests require secrecy, specifically in the context of therapeutic products.
JAAC 67.59 (Art. 62 Abs. 1 HMG)
Hip Prosthesis Case: Anonymized Data Disclosure Upheld
Cited as a ground for refusal of access, pertaining to the confidentiality of data collected under the HMG.