Up-to-date information from the 22.04.-25.04.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

2024 3/7 On page 2, information on the manufacturer (name and address, as well as manufacturing activity in the filed Category” must be provide. With the plus sign at the right margin further input blocks [...] authorisation/registration holder are pre-filled and only have to be completed with the manufacturing activity. On page 3, indicate whether module 3.2.P.3.1 is already applicable at BASG in eCTD format, and [...] 2024 6/7 On page 2, information on the manufacturer (name and address, as well as manufacturing activity in the filed Category” must be provide. With the plus sign at the right margin further input blocks

Referenced at:

• Certificate for a Pharmaceutical Product (CPP)
• FAQ online Service

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

n Unterlagen sowie für die Einreichung von Follow-Up Measurements (FUM, Bewertung der Auflagen), Active Substance Master Files (ASMF) und Periodic Safety Update Reports (PSUR). 2.1 ARTEN DER ÜBERMITTLUNG [...] Email : Contact Number : Company Name : Procedure Number : Comments : Department Type: Regulatory Activity Type Procedure Type : Submission Type : Agency Reference Numbers : http://www.basg.gv.at/filead [...] Email : Contact Number : Company Name : Procedure Number : Comments : Department Type: Regulatory Activity Type Procedure Type : Submission Type : Agency Reference Numbers : Einreichungen mittels DVD/ CD

Referenced at:

• Homeopathic Medicinal Products
• Homeopathic Medicinal Products
• Herbal Medicinal Products
• Herbal Medicinal Products
• Life-Cycle
• Life-Cycle
• Electronic application
• FAQ electronic Submission
• FAQ electronic Submission
• FAQ electronic Submission
• FAQ electronic Submission

Up-to-date information from the 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to appearance of the solution

Indikationen in Österreich? Are there any other marketing authorisations/registrations with identical active substance and indication available in Austria? |_| Nein/ no |_| Ja (Name der Arzneispezialität/en)

Referenced at:

• Life-Cycle
• National authorisation Life-Cycle forms

marketing authorisation/registration holder or applicant commits to continue any risk minimisation activities. |_| Der Berechtigungsnachweis des neuen Zulassungs-/Registrierungsinhabers oder Antragstellers

Referenced at:

• Change of ownership acc. to Art 25 AMG

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