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(F_L381) | 44 KB 01/11/2018 Released Products 2006-2023 Plasma derived products 2006-2023 (diagram) Plasma pools 2006-2023 (diagram) Vaccines 2006-2023 (diagram) Special Services to Shorten and Simplify
will also be made available as a recording. BASG fee schedule for clinical studies As of 01 January 2023 , an updated fee tariff of the BASG was put into force. From this date, index-adjusted tariffs will
the requirements for medicinal products for human use in the document 'Blue-box' requirements may 2023 published on the CMDh website in the section „ Procedural Guidance – Application for MA “. The Blue
ongoing, the amended PL will be authorised as part of the dossier. Reference: CMDh/258/2012/Rev.May 2023 8. Do these new provisions apply to parallel-imported medicinal products? Yes. 9. If the regulation
II National fees Appeal procedure National contact point and concerned ethics committees March 28, 2023 The national legislation supplementing Regulation (EU) 536/2014 ("Clinial Trials Regulations", "CTR") [...] an agreement. This agreement will be published shortly. Decision by the Federal Office December 14, 2023 The decision on an application (initial application or substantial modification) is made by the Federal [...] authorised, the negative decision is the basis for any appeal proceedings. National Applicant March 28, 2023 Regulation (EU) 536/2014 no longer provides for a national applicant. The applicant according to the
Safety of Medicinal Products (MSSG) Provision of data on the availability of antibiotics during winter 2023/24 for the EU-wide assessment of the situation via EMA and HERA Develop and implement the national [...] of the European Shortages Monitoring Platform (ESMP) by February 2025. The ESMP roadmap as of June 2023 is publicly available on the EMA website. The BASG is also working in this area to be able to provide [...] and EMA have published the first version of the Union list of critical medicines on the 12 December 2023. It contains more than 200 active substances of medicines for human use considered critical for healthcare
g. implementation date would be 1.5.2023; however, the company-internal changes are already completed on 1.4.2023. The batch to be certified / released on 15.4.2023 should already be done according to [...] also possible to specify an implementation date in the future (either as a fixed date e.g. "from 1.5. 2023" or as a time period after the date of approval by the BASG e.g. "two months from the date of approval
licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 28/04/2023 hilfenervenschmerzen.com/index_plzze.php Information about this website: no safety logo for mail-order [...] supply of medicines without a pharmacy licence, suspicion of fraud, potential health risks Date: 27/04/2023 fatburnerking.at Information about this website: no safety logo for mail-order pharmacies, website [...] licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 30/03/2023 meridetoxshop.com Information about this website: no registered mail-order pharmacy, no safety logo
Banks). 16. What changes does the revision of Annex 1 of the GMP Guideline have for my company? On 25.8.2023, a revision of Annex 1 of the GMP Guidelines will come into force, to which reference is also made
blood and blood components 04/12/2023 Haemovigilance Report 2022 | 1 MB Only available in German 11/10/2023 Haemovigilance Report 2021 | 567 KB corrected version of 14.09.2023 (only editorial changes compared [...] compared to the publication of 29.11.2022) - Only available in German 14/09/2023 Haemovigilance Report 2020 | 7 MB Only available in German 08/10/2021 Report of the European Commission 2020 | 1 MB Summary