European database , where you will find information on adverse reactions of medical products and active substances (at EU level). Report templates human (only available in German) Formular: Nebenwirkung [...] the relevant information into the EudraVigilance database. The MLM service currently includes 300 active substances and 100 herbals. The results of this research is available for MAHs and member states

r_Tel Telephone number of marketing authorisation holder Grund Reason of the shortage Wirkstoffe Active substances

Contacts Media enquiries relating activities including press releases, press articles and interviews: presse-basg@basg.gv.at Functional E-Mail Addresses Subject E-Mail Active Substance Master File (ASMF, EDMF) [...] at Compassionate use compassionate-use@basg.gv.at Data protection datenschutz@basg.gv.at Dunning activities, due dates basg.mahnungen@basg.gv.at DHPC and education material dhpc-em@basg.gv.at eAF - regulatory [...] lus spp., Streptococcus spp., Phospholipids bovine/porcine (see also CMDh Overview of biological active substances of non-recombinant origin) Quality and Medical assessment of Herbal and Homeopathic Medicinal

EMA - European Medicines Agency General page on the involvement of patients and consumers in the activities of the Agency: EMA interaction with patients and consumers To the website of the working group [...] Our misson is to be the voice of allergy, asthma and COPD patients at European level and to be actively involved in the decisions impacting their health. EFA EURORDIS - Rare Disease Patients in Europe

herbal active substance or combinations of active substances is listed on the EURD list , the submission of a PSUR is required as laid out by the list. If the active substance or combination of active substances [...] (generic, hybrid or well-established use) containing active substances or combinations of active substances not listed in the EURD-list? A PSUR for an active substance or a combination, which is not on the [...] (PSUR) For which kinds of medicinal products should PSURs be submitted? for all active substances and combinations of active substances which are according to the EURD list required to submit a PSUR. These

Since the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) enterd into force, the active use of the UPD for variations not requiring assessment (VNRA) is obligatory for the applicant / marketing

Market Inspectorate, there is no question that each establishment, in accordance with its licensed activity, must have more than the minimum number of qualified persons specified in §§ 6 ff of the Medicines [...] records over the period of delivery until return Date and decision of the assessment of marketability Activities on behalf according to § 29 AMBO 2009: Who is responsible for compliance with GMP/GDP requirements [...] contracting parties. The customer must ensure the suitability of the contractor before taking over the activity in the contract and verify this in audits. A prerequisite for this is also that the contractor has