additional active ingredients (especially toxic or sensitizing active ingredients). ad 2. Any new construction or addition to, or rededication of rooms in which quality-relevant activities are to be carried [...] specifically refers to the requirements of § 63 (2) 1-3 AMG: 1. type, scope and location of the intended activity, 2. The nature, size, equipment, dedication and location of the premises and their equipment, 3

GLP compliance is a legal requirement for this activity. This may in particular be relevant for test facilities that perform chemical-analytical activities in clinical bioequivalence studies. The GLP c [...] period of up to three years. The extension of the validity requires re-inspection, in consequence an active GLP test facility is inspected periodically at intervals of about two to three years. The re-inspection [...] or completed non-clinical studies, which are representatively for the areas of expertise. Without active performance of studies, the BASG is missing part of the basis for its decision-making about the

details as well as exemptions, please refer to § 1 AMBO 2009 or § 62 AMG. Depending on the scope of activity, which includes the facility to be inspected, the requirements of Good Manufacturing Practice or [...] must be met. The annual inspection plan is drawn up on Quality Risk Management on the scope of activities and the degree of compliance with the applicable regulatory requirements and is accredited with [...] the inspection? The content of the inspection depends on the planned or already approved scope of activities. In order to be able to assess which regulatory requirements are applicable to your facility, please

licensing procedures pursuant to Section 63 AMG or Section 65 AMG. My company is a manufacturer of active ingredients that have not yet been included in a marketing authorisation and does not want these [...] (German and English according to the designation in applications for clinical trials, approvals) of the active substances. If explicitly requested, these abbreviations will be indicated in the GMP certificate

ssungen auszufüllen, siehe auch weiter oben unter Punkt „National Authorisation in MRP/DCP/SRP“. Active Substance In diesem Feld ist der Wirkstoff aus dem definierten Katalog hinzuzufügen. Gibt es mehr

Referenced at:

• Electronic application

Änderungen gegenüber der Vorversion

Referenced at:

• Electronic application

Änderungen gegenüber der Vorversion

Referenced at:

• Electronic application

of the 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; Full name of the active substance(s): [...] befüllt werden. Zusätzlich ist, wenn zutreffend, die Base/die aktive Einheit im Feld Base/active moiety of the active substance(s) aus dem definierten Katalog hinzuzufügen. Der Name des Wirkstoffes muss dem [...] Quality of Medicines and Healthcare (EDQM), aus dem vorgegebenen Katalog auszuwählen. Strength (s) and Active substance(s) Strength(s) und Units In diese Felder sind die Stärke und Einheit des Arzneimittels

Referenced at:

• Electronic application

MRP/DCP-Zulassungen auszufüllen, siehe auch weiter oben unter Punkt „National Authorisation in MRP/DCP“. Active Substance In diesem Feld ist der Wirkstoff aus dem definierten Katalog hinzuzufügen. Gibt es mehr

Referenced at:

• Electronic application

Änderungen gegenüber der Vorversion

Referenced at:

• Electronic application