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Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. SwissGMDP database Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.
Tehelj
September 15, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 24 July)

Please note this is an extract of the original bulletin. MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Mutual recognition in principle of inspections by Swissmedic and the FDA. The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in…
Tehelj
August 4, 2023
Membership NewsMembership News Archive

Swiss Representative offer from Confinis

Confinis ag have very kindly provided discounted rates for BIVDA members requiring a Swiss Representative. A Swiss representative is needed to place medical devices on the Swiss market where the manufacturer does not already have a legal place of business within Switzerland. This is in line with the need for an Authorised Representative within the EU. The attached document details…
Ben Kemp
October 28, 2022