Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products
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: Notice to Applicants, Module 1.2, the forms are to be submitted, along with the application dossier.
3. Information on how to fill in the application form is published in Eudralex Vol.2: 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
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: 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.
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: firstname.lastname@example.org, 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.
These German templates have been drawn up in accordance with the QRD Templates (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, 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.
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).
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).