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812.21 HMGLPTHLATER CH

Art. 8 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Principle for placing products on the market

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

Art. 8 TPA · Principle for placing products on the market

Medicinal products and excipients placed on the market must meet the requirements of the Pharmacopoeia or other pharmacopoeias recognised by the Agency provided that such requirements exist.

← Art. 7a TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 9 TPA →

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Court Decisions Applying This Provision (4)

C-5702/2015 (Art. 8 HMG)
Swissmedic Fresh Cell Preparations Authorization Case
Used to establish the binding nature of pharmacopoeia requirements for medicinal products.
36.2011.49 · ti (Art. 8 LATer)
Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication
Cited regarding the requirement for medicines to meet Pharmacopoeia requirements.
C-6050/2008 (Art. 8 ff. HMG)
Seizure of Unapproved Medication for Personal Use Upheld
Details the system of individual administrative approval of preparations.
36.2011.49 · ti (Art. 8 LATer)
Cantonal Insurance Court Upholds Denial of Humira Coverage for Psoriatic Arthritis Without Prior DMARD Failure
Cited in the reasoning regarding requirements for medicinal products being on the market, specifically adherence to pharmacopoeia standards if applicable.