SmPC and PL New 1. For which proprietary medicinal products do the readability, clarity, and user-friendliness have to be assessed in a readability test? When do the results of the readability test ha

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STILISTISCHE BELANGE Stilistische Belange Dokument-Nr.: L_LCM_VIE_REGA_Z44_07 Gültig ab: 21.03.2025 1/5 Institut LCM Abteilung REGA STILISTISCHE BELANGE Nationale Vorgaben für FI/GI/KE (Produktinforma

Referenced at:

• SmPC and PL

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Good Laboratory Practice (GLP) New The Good Laboratory Practice (GLP) is a quality assurance system. Compliance with GLP principles is mandatory for production of safety-relevant test data of chemical

BASG / AGES MEA Institute Surveillance Traisengasse 5 1200 Vienna, Austria F_INS_VIE_00QM_I460_02 Valid from: 17.03.2017 1 of 3 Overview of GLP test facilities inspected Country: AUSTRIA Name of monit

Referenced at:

• Good Laboratory Practice (GLP)

Further information and amendments to the product information in all EU languages are available on the EMA website.

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Further information and amendments to the product information in all EU languages are available on the EMA website.

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Anlage zu § 1 Abs. 1 der Geschäftsordnung des Bundesamtes für Sicherheit im Gesundheitswesen gültig ab dem 13.03.2025.

Referenced at:

• Rules of Procedure (in German only)

Up-to-date information from the 24.02.-27.02.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.