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under the registration number 09282/0. By granting this certification, Quality Austria confirms that BASG and the Austrian Medicines and Medical Devices Agency operate in accordance with and continues to
datenschutz@basg.gv.at Dunning activities, due dates basg.mahnungen@basg.gv.at DHPC and education material dhpc-em@basg.gv.at eAF - regulatory questions basg-cms@basg.gv.at eAF general topics basg-eservices@basg [...] euregulatory@basg.gv.at eServices - technical issues basg-eservices@basg.gv.at Fee and invoice issues basg.fakturierung@basg.gv.at Free Sales Certificate for medical devices fsc@basg.gv.at GLP Good Laboratory [...] Laboratory Practice glp@basg.gv.at Haemovigilance haemoviglianz@basg.gv.at Herbal medicines basg-heve@basg.gv.at Homeopathic medicines basg-heve@basg.gv.at Infrastruktursicherungsbeitrag (ISB) infrastruktursic
y re-evaluate the safety profile of medicinal products and medical devices. For this purpose, the BASG is also in constant exchange of information with other medicines authorities of the European Economic [...] risk, individual product batches can be recalled or warnings issued. Via official notifications, the BASG informs all interest groups at short notice about changes in the safety profile of medicinal products [...] particularly high, the marketing authorisation may also be suspended or withdrawn. Representatives of the BASG participate in Austrian and European committees and working groups, in which these topics are discussed
the CPP, information on the manufacturer, if applicable) as a single document. Contact E-Mail: cpp@basg.gv.at Form: Application for a Certificate for a Pharmaceutical Product (F_M69) | 46 KB 23/07/2019
procedure? No, but the outcome of the PSUSA will be published on the EMA homepage or on the BASG homepage: https://www.basg.gv.at/en/companies/pharmacovigilance/pv-wordings Risk Management Plans (RMP) Which medicinal [...] the BASG website. Is a joint design or sending of DHPC or Educational Material, which refers to an active substance (cross-company) or to a Class Labelling, controlled and coordinated by the BASG? The [...] The cooperation of the companies concerned is supported by the BASG. A coordination by the BASG is not possible. What are the requirements with regard to the distribution list? The companies will certainly
or usage information for use shall apply. For legally binding information, please contact us at basg@basg.gv.at . The Federal Office for Safety in Health Care therefore accepts no liability for the accuracy [...] the Register of Proprietary Medicinal Products and BASG pronouncements Timeliness of the data in the Register of Proprietary Medicinal Products and BASG pronouncements Data is updated over night and the [...] Terms for use Terms of use Data provision www.basg.gv.at and data interfaces (web services) The Federal Office for Safety in Health Care takes great care in providing information on drug specialties, procedure
rms@basg.gv.at For general requests concerning DC- and MR-procedures please contact BASG via: Tel. national: 050 555-36666 Tel. international: +43 (0)50 555-36666 Email: hotline.euregulatory@basg.gv.at [...] State to Austria, a completed CMD(h) request form (Template for RMS change) should be sent to rms@basg.gv.at .The CMD(h) request form can be found in the Download section or on the CMD(h) website . This
leaflets for all medicinal products authorised in Austria in the Austrian Medicinal Product Index of the BASG. Please consult your doctor if you notice that you should not take the prescribed medicine because
from human cells and tissues can be found at www.basg.gv.at/gesundheitsberufe/gewebesicherheit , www.basg.gv.at/gesundheitsberufe/blutsicherheit und www.basg.gv.at/fuer-unternehmen/bewilligung-und-zertif [...] guideline is not legally binding. Binding information requires a separate request (to ATMP-leitfaden@basg.gv.at ) and can only be provided for specific cases after thorough examination of all information
eu or georg.neuwirther@ages.at respectively nat@basg.gv.at for national applications, rms@basg.gv.at for applications where AT acts as RMS and basg-cms@basg.gv.at for applications where AT acts as CMS. CESP [...] neuwirther@ages.at or our functional e-mail addresses (nat@basg.gv.at for national applications, rms@basg.gv.at for applications with AT=RMS and basg-cms@basg.gv.at for applications with AT=CMS). [...] specific CESP submissions, please contact cesp@basg.gv.at . Further information on CESP can be found at the HMA . eCTD/VNees When switching to the eCTD format , the BASG recommends that at least Module 3 be submitted