Up-to-date information from the 24.01.-27.01.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

reference to the active substance, effect or efficacy. It must be ensured that the artwork design does not lead to any confusion: o It is not allowed to bring to market medicinal products or active substances [...] presentation. o It is not allowed, in connection with the placing on the market of medicinal products or active substances, to provide information that is inaccurate or likely to mislead the public. o Misleading [...] 5, 1200 Vienna, Austria 3 of 8 the medicinal products are considered to have an efficacy or the active substances are considered to have a property which according to the current state of scientific

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• Mock-ups

Request for MRP, SRP or DCP for medicinal products for veterinary use

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• DCP/MRP/RUP/SRP Slots

screening activities and more in-depth analysis may not always be clear-cut. Users are thus recommended to identify the end of screening activities and the beginning of any subsequent research activities, and [...] next to the main enzymatic activity, a variable and often diverse range of enzymatic side activities due to gene functional expression. The products of these side activities will usually also be present [...] Certain types of activities – for example, research under specific cooperation programmes – may also be excluded from a given country’s access legislation, and in that case such activities would not trigger

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• Utilisation of genetic resources and traditional knowledge associated with genetic resources

Before collecting, acquiring or using a genetic resource, the legal requirements that apply to these activities in the respective country of origin have to be clari- fied. Information can be found, for example [...] documentation For the purpose of demonstrating compliance with the due diligence obligation, the activity or process falling within the scope of the EU ABS Regulation has to be documented in accordance [...] there is a change in the use of a genetic resource in the course of the research and development activities (e.g. development of another product based on the same genetic resource), the permits and contractual

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• Utilisation of genetic resources and traditional knowledge associated with genetic resources

Diese Gebührenverordnung findet Anwendung auf alle Anbringen, die ab dem 28.01.2022 beim BASG eingegangen sind.

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• Fees

Up-to-date information from the 13.12.-16.12.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Date: 4-7 December 2012 MJA 08/07 Date: 11-14 December 2007 Field of Activity As main activities, CPAA is involved in: 1) Activities related to the national market • Legal Supply Chain: Authorised Medicines [...] Group (AMEG) combating illegalities in the medical market and the prevention of illegal activities. 2) Activities related to the Network • CAP, MRP/DCP, MSS, establishment of Ph. Eur. CRS and participation [...] (FID) 2.2.28. Gas chromatography, Mass spectrometry (MS) 2.2.28. Including PV_702 "Identification of active substances in unknown products by GC-MS" Liquid chromatography, Diode array (DAD) 2.2.29. EUROPEAN

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• Quality Management

Recall of two batches due to a deviation of the active substance content diphenhydramine

Recall due to azido contamination above the acceptable limit.