German_Guideline_CTA

BfArM - Guide to Submission - Guide to the Submission of Applications for Marketing A... Page 1 of 3
Guide to Submission
Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products
A printed set of forms is to be used for applications for marketing authorisation of medicinal products pursuant to Section 21 et sqq. of the
German Medicines Act (Arzneimittelgesetz, AMG) submitted to the BfArM in accordance with the "Announcement on the Authorisation of
Medicinal Products - New Set of Form for Marketing Authorisation of a Medicinal Product by the Federal Institut for Drugs and Medical Devices
and by Paul-Ehrlich-Institute/Federal Agency for Sera and Vaccines, 21 January 2003"
(Original German title: "
Bekanntmachung über die Zulassung von Arzneimitteln - Neuer Formularsatz für den Antrag auf Zulassung eines Arzneimittels beim
Bundesinstitut für Arzneimittel und Medizinprodukte und beim Paul-Ehrlich-Institut/Bundesamt für Sera und Impfstoffe (PDF, 33KB, File does not
fully comply with accessibility standards)
" (BAnz. /Federal Gazette/ No. 69a, 09 April 2003).
Annotations to the application as well as the text of the German Medicines Act can be obtained from the Bundesanzeiger-Verlagsgesellschaft mbH,
Postfach 10 05 34, 50445 Köln or at bookshops.
Note: Based on the 14th Amendment of the German Medicines Act new requirements and a new application procedure have been
introduced. An updated set of forms in German is not yet available. Therefore, we kindly request use of the European form inEudralex Vol. 2
[http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm]: [http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm]
Notice to Applicants, Module 1.
Recommendations that should be followed:
1. Prior filing an application, an informal letter should be sent, preferably be telefax, to Bundesinstitut für Arzneimittel und Medizinprodukte,
Fachregistratur Z14.1, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn - telefax number: +49 228 207 3681 stating the name and pharmaceutical
form of the medicinal product and requesting a processing number.
2. The set of forms is available via the above mentioned link as a template that can be completed. When filled in completely, with due regard to
the European requirements valid at the time as stated in Eudralex Vol.2 [http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm]:
Notice to Applicants, Module 1.2, the forms are to be submitted in paper, along with the application dossier.
3. Information on how to fill in the application form is published in Eudralex Vol.2
[http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm]: Notice to Applicants - "User guide for the application form".
4. Where their contents still comply with current requirements, the BfArM's explanatory notes concerning applications for marketing authorisation
of medicinal products, 3rd edition, 31 Octobre 1996/"Erläuterungen zum Antrag auf Zulassung eines Arzneimittels beim Bundesinstitut für
Arzneimittel ubd Medizinprodukte" (BAnz. No. 44a, 5 March 1997) (see also points 5-16) should be followed.
5. If a licence is sought in a purely national authorisation procedure, the application form needs to be filled out in German in accordance with
Section 22 sub-section 1 AMG.
6. If the application concerns an authorisation of a parallel-imported medicinal product, a specific form
Erklärung zum besonderen Mechanismus (RTF, 245KB, File does not fully comply with accessibility standards)
is to be submitted in addition to the application for marketing authorisation.
7. Regarding the formal arrangement of the dossier (Modules 1.3 to 5, Common Technical Document CTD - obligatory as of November 1, 2003),
the current requirements of Eudralex Vol. 2 [http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm]:
[http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm] Notice to Applicants should be followed.
8. Regarding the documents to be transmitted (point 2) and the required EU documents (point 3), the Announcement regarding Submission of
Applications for Marketing Authorisation and Dossiers to the Federal Institute for Drugs and Medical Devices, 15 October 1998/ Bekanntmachung
zur Einreichung von Zulassungsanträgen und Unterlagen für Arzneimittel beim Bundesinstitut für Arzneimittel und Medizinprodukte (BAnz. No.
201, 27 October 1998, p. 15405) should be followed.
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9. The draft texts pursuant to Sections 10, 11, and 11a AMG (Module 1.3.1) and expert reports pursuant to Section 24 AMG (Module 2) are to be
sent electronically to the address: zulassung@amg-zulassung.de, in accordance with the AMG_submission Ordiance of 21 December 2000
(BGBl. /Federal Law Gazette/ I No. 60, p. 2063). Current explanatory notes on the enforcement of the AMG-Submission Ordinance are available on
the BfArM's homepage: Erläuterungen zum Vollzug der AMG-Einreichungsverordnung - Version 5.0, Stand 01.07.2007.
10. Templates for Summary of Product Characteristics and Package Leaflet
Based on the 14th Amendment of the German Medicines Act, Sections 11 and 11a AMG, the structure and details of the user information for
patients and healthcare professionals have been revised. This revision has brought them in line with European requirements. In order to ease
implementation of these new requirements, BfArM provides templates for Package Leaflets for over-the-counter and prescription-only products as
well as for SPCs. Consequent use of these templates will encourage a consistent and smooth implementation.
Format-Vorlage Gebrauchsinformation, nicht verschreibungspflichtig (RTF, 106KB, File does not fully comply with accessibility standards)
Format-Vorlage Gebrauchsinformation, verschreibungspflichtig (RTF, 105KB, File does not fully comply with accessibility standards)
Fachinformation (SPC) (RTF, 65KB, File does not fully comply with accessibility standards)
These German templates have been drawn up in accordance with the QRD Templates [http://www.ema.europa.eu/ema/index.jsp?
curl=pages/regulation/document_listing/document_listing_000134.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580022c59]
(stands for Quality Review of Documents) so that there should be no major structural differences in the future. Several annotations have been
integrated so that it will not be necessary to constantly consult the information published on the EMEA website by the QRD group.
The abbreviation „/.../" stands for the invented name of the medicinal product.
These templates will also be used for the compilation of core texts as well as for the notice of marketing authorisation.
When composing Package Leaflets please refer to the Announcement regarding Recommendations for the Presentation of the Package Leaflet
under Section 11 AMG for Human Medicinal Products (in accordance with Section 77 sub-section 1 AMG) and for the Requirements of Section 22
sub-section 7 sentence 2 AMG (Evaluation as to the Readability of Package Leaflets)
Bekanntmachung von Empfehlungen zur Gestaltung von Packungsbeilagen nach § 11 des Arzneimittelgesetzes (AMG) für Humanarzneimittel
(gemäß § 77 Abs. 1 AMG) und zu den Anforderungen § 22 Absatz 7 Satz 2 AMG (Überprüfung der Verständlichkeit von Packungsbeilagen) (PDF,
30KB, File is accessible)
of 14 April 2015.
When composing SPCs please refer to Eudralex Vol. 2 [http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm], Guideline on
Summary of Product Characteristics.
11. With regards to the scientific requirements concerning the documentation of quality, pharmacology/toxicology and clinical aspects (Modules 3
to 5), special attention should be paid to Directive 2001/83/EC and the Scientific Guidelines for Human Medicinal Products
[http://www.ema.europa.eu/ema/index.jsp?
curl=pages/regulation/general/general_content_000043.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800240cb&jsenabled=true].
12. Regarding the European Active Substance Master File (ASMF) procedure, the "Guideline on Active Substance Master File Procedure" should be
followed (for further information see Guideline on ASMF [http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?
webContentId=WC500129994]).
13. If ionising radiation treatment is used during manufacture, an Application for marketing authorisation in view of treatment with ionising
radiation during manufacture (Section 1 subsection 2 sentence 1 No. 4 AMRadV)/ Antrag auf Zulassung im Hinblick auf die Behandlung mit
ionisierenden Strahlen bei der Herstellung (§ 1 Abs. 2 Satz 1 Nr. 4 AMRadV) should be attached to the application form as Annex 8.
The marginal number 169 which continues to be applicable and Annex 7 to the Explanatory Notes concerning Applications for Marketing
Authorisation of Medicinal Product to the BfArM, 31 October 1996 are to be observed.
14. If no comparative studies of bioavailability/bioequivalence are presented, the reasoning for not having conducted in-vivo studies should be
attached to the application as Annex 9, in a separate file and in two copies. The requirements to be met in such cases are specified in the
Abbizbcement ragarding the Authorisation of Medicinal Products in accordance with Section 21 AMG (Bioavailability/Bioequivalence), 18
December 2002/ Bekanntmachung über die Zulassung nach § 21 des Arzneimittelgesetzes (AMG) (Bioverfügbarkeit/Bioäquivalenz) vom 18.12.2002
(BAnz. of 25 March 2003, p. 5296).
15. Pursuant to the Notice to Applicants, Vol. 2 A Chapter 7 [http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm], (footnote 2) and
Requirements on Electronic submissions for New Applications within MRP, DCP or National procedures
[http://www.hma.eu/uploads/media/eSubmissions_requirements_new_applications.pdf], the BfArM requires one complete paper version including
a hand signed application form and two-fold electronic versions (CD/DVD) preferably in accordance with eCTD specifications for all applications for
marketing authorisation. More detailed information on structuring and formatting of Non-eCTD electronic Submissions (NeeS)
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[http://esubmission.emea.europa.eu/doc/eGuidance_Document%201.4.pdf] will be available at EMEA. Draft texts of the product information in rtfformat should be submitted additionally in accordance with the Explanatory Notes on the Enforcement of the AMG-Submission Ordinance
available on the BfArM's homepage: Erläuterungen zum Vollzug der AMG-Einreichungsverordnung - Version 5.0, Stand 01.07.2007
If one applicant submits several applications concurrently, submission of the full dossier for the lowest procedure number is sufficient if the
applications refer to the same active substance and differ only regarding the invented names of the medicinal product (or in the case of Modules 4
and 5 also regarding different strengths) and if the dossiers (Modules 2 to 5) or parts of the dossiers (Modules 4 and 5) are identical. Under the
precondition of identity of Modules 2 to 5, reference can be made to these dossiers for the additional applications. In such cases, no additional
paper versions are required, however, the complete electronic version is to be submitted.All concurrently submitted applications referring to the
same dossier should be referenced in the cover letter, the folder label, and on the first page of the dossier together with their respective
procedure numbers.
16. The application dossier should be sent to the following address:
Bundesinstitut für Arzneimittel und Medizinprodukte
Fachregistratur - Antragseingang
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Additional Information
© BfArM - 2013
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