increase growth or yield. Optional centralised authorisation New active substances for indications other than those mentioned above if this active substance has not yet been authorised in the EU. Significant [...] (e.g. patient-friendly formulation/administration) Generics (e.g. generics of centrally authorised active substances) In the central procedure, the applicant submits a marketing authorization application

submitted by appropriately trained staff in accordance with the following: Excellent knowledge and active implementation of the above mentioned criteria and literature Excellent knowledge of German Excellent [...] Excipients-Guideline PV-Wordings , wordings following Paediatric Worksharings - wordings for the active substance(s) EMA: Medicines under Additional Monitoring EMA: QRD-Template BASG German QRD-Template [...] medicinal product European Pharmacopoeia (german translation), Austrian Pharmacopoeia: Notation of active pharmaceutical ingredients and excipients AT Guidance document – Mock-ups Conditional authorisation

medicines, which contain exclusively one or more herbal substances as the active ingredient. Biological medicinal products, whose active ingredients are either isolated from biological materials (e.g. from [...] that the two chemical-synthetic substances have the same chemical formula, but the two biological active ingredients are not identical but similar ("similar"). This often gives rise to the misconception [...] Comparison of medicinal product quality (comparability of physicochemical properties and biological activity) Step - Comparison of preclinical properties (comparative preclinical studies) Step - Comparison

Counterfeit medicines pose a massive health risk: They contain either no active substance or another active substance or an active substance in ineffectively low or dangerously high concentrations. The use [...] this service must report this to the Federal Office for Safety in Health Care before taking up this activity. After registration, the Federal Office for Safety in Health Care includes the pharmacy in a list

following notification type: Annual report/activity report To the online submission (The online reporting is only available in German.) Annual report on activities of tissue establishments From 01.01.2022 [...] report on activities of tissue establishments is 30.04. of the following year! The annual report is submitted in the eService by selecting the following notification type: Annual report/activity report To [...] the previous calendar year. Reports Summarizing report on activities of the Austrian tissue establishments A summarizing report on activities of the Austrian tissue establishments may be consulted publicly

Some improvements to the electronic user management of eServices are planned for the current year 2024, which we would like to point out to you below.

place and duration of meeting, name and contact details of applicant, name of product (if available), active ingredient, and a list of participants. BASG will review the draft minutes and may change them as

Referenced at:

• Scientific advice by BASG

warning message will be issued beforehand to prevent the organization from accidentally running out of active administrators. 5. In the future, notification emails can be sent to different user groups based

Referenced at:

• BASG/AGES eServices – Adaptation of electronic user administration (eBA)

1 AWEG, which only have to be filled or packaged to become the final product). Intermediates or active substances are not covered by the term 'medicaments' and are not covered by the AWEG. The term blood [...] import by requesting documents or by on-site inspection (§ 20 AWEG). In the case of inspection activities, it accesses documents which must be available to the declarants or applicants in order to fulfil [...] containing human blood or manufactured from human blood. They may only be transported to Austria if the activities of the blood establishments in connection with the collection and testing of human blood have received

General-EMEA/CMDh/619614/2008

Referenced at:

• DCP/MRP/RUP/SRP Slots