the active substance(s) sind im Fall mehrerer Wirkstoffe in der selben Reihenfolge zu befüllen (z.B. FEB-PRAZ-PYR 150mg/50mg/144mg - Tabletten: Stength(s): 150mg/50mg/144mg; Full name of the active sub [...] ausgefüllt werden. 1.2 Application for a variation requiring assessment that is classified as a change of active substance(s), strength, pharmaceutical form, route of administration or food- producing target species [...] Dokument „Standard Terms Introduction and guidance for use“ sowie das “CVMP Reflection paper on new active substance (NAS) status of chemical substances for VMPs (EMA/CVMP/QWP/3629/2016)” soll zu Rate gezogen

Referenced at:

• Electronic application

Strength(s) und Active Substance(s) sind im Fall mehrerer Wirkstoffe in der selben Reihenfolge zu befüllen (z.B. Lisinopril/HCT 50mg/12,5mg - Filmtabletten: Strength(s): 50mg/12,5mg; Active Substance(s): [...] und Einheit des Arzneimittels einzutragen. Bei mehr als einer Stärke ist das Feld zu duplizieren. Active substance(s) (including salt or hydrate)In diesem Feld ist der Wirkstoff aus dem definierten Katalog [...] ausgewählt werden. Mehrere Angaben sind durch Duplizieren des Feldes möglich. Manufacturer(s) of the active substance(s) Name und Adresse aller Wirkstoffhersteller (inkl. der Produktionsstätte) Alle Produ

Referenced at:

• Electronic application

terms of quality, extensive data on both the active substance and the finished product have to be provided. To avoid multiple assessments of identical active substance documentations by different authorities [...] that the quality of the active substance in question is adequately documented. Future application dossiers only need to include a copy of the CEP rather than an extensive active substance documentation [...] need for repeat assessments of the active substance. Furthermore, the same procedure is in place to evaluate TSE (Transmissible Spongiform Encephalopathy) risk of active substances and excipients and hereby

products that fall into the following categories are affected: medicinal products that contain a new active substance that did not appear in any authorised medicinal product in the EU as of 1 January 2011;

if the new holder cannot take over the eCTD sequences for technical reasons The first regulatory activity is then submitted with sequence 0001. 3. baseline submission at a later stage in the lifecycle It

The committee on herbal medicinal products (HMPC) of the European Medicines Agency (EMA) published the revised Public Statement on the use of herbal medicinal products1 containing estragole.

product-specific variants and impurities, biological activity). The official approval of biological medicinal products with recombinant proteins as active ingredients takes place in the EEA within the framework [...] Recombinant proteins Recombinant proteins as active ingredients of biotechnologically produced drugs (biopharmaceuticals) are produced in multi-stage, complex manufacturing processes: In an upstream processing [...] protein are cultured in bioreactors and finally stimulated to produce (express) the target protein. The active ingredient is then extracted, purified and concentrated in downstream processing. In addition, various

must inform the BASG before commencing their activities, stating the name of the authorized person and the address, the date of commencement of the activity and the address of the websites used for this [...] veterinary medicinal specialties to the BASG Public pharmacies that have already notified their activities to the BASG in accordance with Section 59a para. 2 AMG as amended are exempt from the obligation

Up-to-date information from the 19.02.-22.02.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

sprays, gels, creams or ointments to treat a hormone deficiency. Through direct or indirect contact, active substance residues can be transferred from the skin to pets and cause symptoms of illness. In the