additional monitoring is carried out in the following cases: if the medicinal product contains a new active substance approved in the EU after 1 January 2011; in the case of a biological medicinal product

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

third country authority and reported to the BASG, the BASG is obliged to initiate corresponding activities.

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.

(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

medicine is thus, in contrast to the graduates of dentistry, not yet entitled to practice medical activities in the sense of physician law. This is only the case when the Austrian Medical Association has [...] clinical trial can be drawn further than monthly with conclusive justification, e.g. in periods without active substance administration, and When determining the interval, in addition to the protection of the

in Health Care (Pharos) will be amended accordingly. Changes to the prescription status will be actively communicated to the marketing authorisation holder by the Institute Marketing Authorisation of Medicinal

the GMP-conformity of the active substance manufacturer? 12. Do the Qualified Persons have to confirm the GMP-conformity of the active substance manufacturer even if the active substance manufacturer has [...] the GMP-conformity of the active substance manufacturer even if the active substance manufacturer has a GMP-certificate? Yes. A declaration on the GMP-conformity of the active substance manufacturer(s) [...] the active substance manufacturer? The Qualified Persons (QP) of every manufacturer responsible for batch release in the EEA and of every finished product manufacturer must declare that the active substance

parties. Among other things, applications, user contracts and access data were necessary in order to activate all the dispensing offices and thus continue to ensure authorisation to supply prescription medicines

undertakes a number of activities, including drafting legislation and developing guidelines, supporting national authorities with its implementation, accompanied by vigilance activities and project support [...] mobile collection teams, where activities related to the procurement of human cells and tissues for human application are performed. Tissue bank : Establishment where activities related to the processing, [...] establishments and approved tissue banks. This register also has to contain information on the activities for which certification or approval was granted. The register is maintained through the European