BfArM - Federal Institute for Drugs and Medical Devices

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For multiple applications of the same medicinal product rtf, 22KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Parallelanträge für das betreffende Arzneimittel)

Qualitative and quantitative composition in terms of the active sunstance(s) and the excipient(s) rtf, 187KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Zusammensetzung nach Art und Menge von Wirkstoffen und Hilfsstoffen)

Authorised manufacturer(s) (or importer) responsible for batch release in the EEA rtf, 181KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Für die Chargenfreigabe im EWR verantwortliche Hersteller)

Manufacturer(s) of the active substance(s) rtf, 184KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Wirkstoffhersteller)

Marketing authorisation applications for the same product in the EEA rtf, 182KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Zulassungsäntrage für das betreffende Arzneimittel im EWR)

Was there a scientific recommendation given by Member State(s) for this medicinal product rtf, 20KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Erfolgte durch einen/mehrere Mitgliegstaat/en eine wissenschaftliche Empfehlung zu diesem Arzneimittel)

Manufacturer(s) of the medicinal product and site(s) of manufacture rtf, 183KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Hersteller des Arzneimittels und Betriebsstätte(n))

Annex to Application for Sera, Vaccines, Blood Products and Allergens rtf, 15KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Anlage zum Zulassungsantrag bei Sera, Impfstoffen, Blutzubereitungen und Testallergenen)

Contract companies used for bioavailability or bioequivalence trials or used for the validation of blood product manufacturing rtf, 23KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Vertragsunternehmen für die Bioverfügbarkeits-/Bioäquivalenzstudien bzw. Validierung der Herstellungsprozesse bei Blutprodukten)

Ordinance on the Submission of Documents within Licensing and Renewal Procedures For Medicinal Products (AMG-Submission-Ordinance, AMG- Einreichungsverordnung, AMG-EV) of 21 December 2000 PDF, 49KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Download

Ordinance on the Submission of Documents within Licensing and Renewal Procedures For Medicinal Products (AMG-Submission-Ordinance, AMG- Einreichungsverordnung, AMG-EV) 21 December 2000

Cover letter
concerning the renewal application
rtf, 167KB, File does not meet accessibility standards
Date: 07. March 2005 Topics: Licensing Type: Form

(available in German only)

Is there a prescribed format for listing the manufacturers in the IMPD? Date: Topics: Licensing Type: FAQ

In order to simplify assessment by the BfArM, we ask you to list the manufacturers in the IMPD as follows:

First, the name of the manufacturer including the complete address should be given. Then, all manufacturing activities carried out by this …

Is there a prescribed format for listing the manufacturers in the IMPD? Date: Topics: Licensing Type: FAQ

In order to simplify assessment by the BfArM, we ask you to list the manufacturers in the IMPD as follows:

First, the name of the manufacturer including the complete address should be given. Then, all manufacturing activities carried out by this …

When does an importer have to be appointed and who can assume this function? Date: Topics: Licensing Type: FAQ

If an investigational medicinal product is manufactured outside the EU or EEA an importer is necessary. If investigational medicinal products are transported within the EU or the EEA no importer has to be stated. The importer has to have a …

What has to be supplied instead of a manufacturing authorisation for manufacturing sites located in a third country (outside the EU or the EEA)? Date: Topics: Licensing Type: FAQ

For manufacturing sites located in a third country the qualified person of the importer has to issue a GMP certificate. In this GMP certificate the qualified person of the importer certifies that each production batch has been manufactured and …

Does an ASMF for the authorisation procedure of a clinical trial have to contain a Quality Overall Summary? Date: Topics: Licensing Type: FAQ

No, as no Quality Overall Summaries have to be submitted in the course of authorisation procedures for clinical trials, an ASMF for a clinical trial does not have to contain a Quality Overall Summary.

However, an ASMF without a Quality Overall …

Which parts does an ASMF for a clinical trial have to consist of? Date: Topics: Licensing Type: FAQ

ASMF used for a request for authorisation of a clinical trial must contain the documentation on manufacture and testing of the active substance to the same extent necessary for the evaluation of investigational medicinal products. Furthermore, …

What information is to be included in the request for authorisation of a clinical trial when referring to an ASMF? Date: Topics: Licensing Type: FAQ

In addition to submission of the letter of access from the manufacturer of the active substance, the cover letter accompanying the application should point out that reference is being made to an ASMF. This ensures prompt consolidation of the …

How should the documentation be submitted? Date: Topics: Licensing Type: FAQ

The ASMF should be submitted at least 2 weeks prior (!) to the request for authorisation of a clinical trial. The reference line of the cover letter should make clear that an ASMF is being submitted. The EudraCT number of the clinical trial for which …