(i.e., in individuals <18 years of age). The European Medicines Agency (EMA) compiles a list of active substances to be assessed in accordance with Article 45, and the Co-ordination Group for Mutual [...] implementing the text recommendations into the SmPCs and PLs of the medicinal products containing the active substance and available in the formulation in question lies with the MAH. To implement the changes

veterinary medicinal products are considered line extensions: 1. Changes to the active substance(s): (a) replacement of a chemical active substance by a different salt/ester complex/derivative, with the same t [...] biological active substance with one of a slightly different molecular structure where the efficacy/safety characteristics are not significantly different, with the exception of: changes to the active substance

by detecting and ending illegal activities on the basis of suspicious activity reports. However, particular attention is also paid to the prevention of illegal activities.

intended conditions of use and that any risks are acceptable in relation to the benefits. What are the activities of the BASG in the field of medical devices? The Federal Office for Safety in Health Care (BASG) [...] from vigilance and other complaints from the Austrian or European market. Market surveillance activities verify that the characteristics and performance of medical devices comply with legal requirements

trade licence in accordance with § 116 of the Gewerbeordnung are only entitled to commence their activities as pharmaceutical wholesalers if they are authorised in accordance with § 63 AMG. This can be found

only) 02/06/2010 active+med Magen-Darm-Pastillen | 646 KB Assessment of the Advisory Board on Classification regarding active+med Magen-Darm-Pastillen (German only) 02/12/2009 active+med Wund- und Son [...] only) 06/05/2008 active+med Halstabletten Zitrone | 999 KB Assessment of the Advisory Board on Classification regarding active+med Halstabletten Zitrone (German only) 23/04/2008 active+med Halstabletten [...] regarding Akuz (German only) 30/04/2009 well & active Eukalyptus-Balsam | 190 KB Assessment of the Advisory Board on Classification regarding well & active Eukalyptus-Balsam für Babys und Kleinkinder (German

n may be repeated five times (i.e. a total of six times), unless stated otherwise. However, some active substances (e.g. antibiotics or diazepam) are prohibited from being dispensed repeatedly, so that

How are we supposed to validate our process if we use a third-party data system for GMP-relevant activities? GMP relevance of a system and validation obligation is given if a manufacturing step is supported [...] during validation. What are the responsibilities for carrying out a risk analysis? How should this activity be defined? The risk analysis should always be performed by the user. When transferring a risk analysis

contains a detailed description of the circumstances under which a medicine should not be taken. All active ingredients and other excipients of a medicinal product are listed in the package leaflet in section

ASMF 1. How to submit an ASMF? 2. What are the requirements for an Active Substance Master File (ASMF), which is part of an application for marketing authorisation, variation or renewal? 3. How should [...] documents see Guideline: electronic Release Regulation EEVO (L_Z45) . 2. What are the requirements for an Active Substance Master File (ASMF), which is part of an application for marketing authorisation, variation