BfArM - Federal Institute for Drugs and Medical Devices

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Further Regulatory Information on Submissions Date: 31. January 2017 Topics: Licensing Type: Article

Further Regulatory Information on Submissions

EudraCT Tutorials Date: 05. July 2016 Topics: Licensing Type: News

EudraCT has made multimedia tutorials for clinical trial results available on its website.

Inhaltsverzeichnis des Europäischen Arzneibuchs, 8. Ausgabe, 8. Nachtrag PDF, 52KB, File does not meet accessibility standards Date: 31. May 2016 Topics: Licensing Type: Download

Inhaltsverzeichnis des Europäisches Arzneibuches
Contents of Supplement 8.8 EUROPEAN PHARMACOPOEIA 8.8

National Variations Date: 31. March 2016 Topics: Licensing Type: Article

National Variations

Opinion No. 02/2016 of the Joint Expert Committee on Classification of Substances
PDF, 2MB, File is accessible
Date: 24. February 2016 Topics: Licensing Type: Download

Classification of red yeast rice products

see also press release on the topic

Update of the BfArM-websites in the section eSubmission including an update of the eValidator Date: 18. February 2016 Topics: Licensing Type: News

The BfArM updated its websites in the section eSubmission due to the use of electronic application forms (eAF) as of 1 January 2016.

In addition the BfArM offers an updated version of a tool which checks your dossier against …

Processing Statistics of the BfArM 2015 PDF, 221KB, File does not meet accessibility standards Date: 16. February 2016 Topics: Licensing Type: Download

State: February 2015

Electronic Common Technical Documents (eCTD) Date: 09. February 2016 Topics: Licensing Type: Article

eCTD

Step-by-step Guide on e-only Submission at BfArM Date: 09. February 2016 Topics: Licensing Type: Article

eSubmission

General rules for acceptance of so-called electronic-only submissions Date: 09. February 2016 Topics: Licensing Type: Article

Acceptance of so-called electronic-only submissions

Advice of BfArM regarding the use of electronic application forms (eAF) as of 1 January 2016 Date: 09. February 2016 Topics: Licensing Type: Article

Since 1 January 2016 important changes have to be observed by applicants. BfArM wishes to call pharmaceutical companies' attention to the following essential modifications.

Information from BfArM regarding paper submission after 5 August 2013 Date: 09. February 2016 Topics: Licensing Type: Article

Based on changes to the administrative practise of 5 August 2013, BfArM no longer requires paper-based submissions for all application procedures, specifically in cases where the PharmNet.Bund portal, CESP or electronic storage media (CD/DVD) …

Using the COMMON EU SUBMISSION PLATFORM (CESP) for electronic submissions to the BfArM Date: 09. February 2016 Topics: Licensing Type: Article

CESP

Opinion No. 01/2016 of the Joint Expert Committee on Classification of Substances PDF, 600KB, File is accessible Date: 21. January 2016 Topics: Licensing Type: Download

Evaluation of products containing vitamin D

A press release on this topic can be found on the BVL page

National Licensing Procedures Date: 04. January 2016 Topics: Licensing Type: Article

Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products

Joint Declaration of Cooperation_BfArM TFDA PDF, 1MB, File does not meet accessibility standards Date: 22. October 2015 Topics: Licensing Type: Download

Joint Declaration of Cooperation_BfArM TFDA

In which cases should I submit a purely national variation procedure? Date: 13. October 2015 Topics: Licensing Type: FAQ

The answer is given under topic Purely National Variation Procedures

In which cases should I submit a purely national variation procedure? Date: 13. October 2015 Topics: Licensing Type: FAQ

As of 4 August 2013, the rules laid down in Chapter IIa of Commission Regulation (EC) No 1234/2008 of 24 November 2008 ("Variation Regulation") as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 continue to be applicable for the …

How is a variation with regard to the marketing status of already licensed pack-sizes to be submitted? Date: 24. August 2015 Topics: Licensing Type: FAQ

As variations in the marketing status (distribution or non-distribution in Germany) of licensed pack-sizes are variations to the informative texts, they are to be classified as type IB variation category C.I.z.

The BfArM recommends …

What is meant with "reference medicinal product” as stated in the variation category C.I.2 according to the "Guidelines on the details of the various categories of variations" […] and which information is required in the application form for an adaptation to the product texts of the “reference medicinal product[s]”? Date: 11. May 2015 Topics: Licensing Type: FAQ

The reference medicinal product is defined in Art. 10(2)(a) of Dir. 2001/83/EC. This is the medicinal product, to which a marketing authorisation application according to 10(1) or 10(3), resp., Dir. 2001/83/EC refers to.

If there are changes in the …

Written renouncement Date: 21. April 2015 Topics: Licensing Type: Article

Written renouncement

Form Section 29 sub-section 1g AMG rtf, 216KB, File does not meet accessibility standards Date: 21. April 2015 Topics: Licensing Type: Form

Form Section 29 sub-section 1g AMG

Processing Statistics of the BfArM 2014 PDF, 175KB, File does not meet accessibility standards Date: 26. March 2015 Topics: Licensing Type: Download

State: March 2014

Parallel import of medicinal products Date: 11. February 2015 Topics: Licensing Type: Article

Parallel import of medicinal products

Opinion No. 01/2014 of the Joint Expert Committee on the Classification of Substances PDF, 105KB, File is accessible Date: 06. February 2015 Topics: Licensing Type: Download

Classification of certain vital mushroom products (here: Cordyceps sinensis, Coriolus versicolor and Ganoderma lucidum)

Information on WHO Certificates issued by the BfArM in accordance with Section 73a sub-section 2 AMG Date: 27. January 2015 Topics: Licensing Type: Article

In accordance with Section 73a sub-section 2 AMG, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues a certificate corresponding to the World Health Organisation's …

Information on the electronic submission ("e-only") of follow-up applications Date: 06. January 2015 Topics: Licensing Type: FAQ

General Rules

The advantage of avoiding paper submissions can be used only when

  • switching to or maintaining the eCTD or NeeS format in accordance with the published specifications for EU Module 1 and ICH Modules 2 to 5 respectively the NeeS

Do you have to notify the competent authority about samples of finished medicinal products? Date: 11. December 2014 Topics: Licensing Type: FAQ

If the smallest pack size on the market is used as a sample, the competent authority does not need to be notified of this. However, compliance with the requirements of Section 47 sub-section 3 of the German Medicinal Products Act ("

When does the data exclusivity of a centrally authorised medicinal product start? Date: 26. November 2014 Topics: Licensing Type: FAQ

Data exclusivity of a centrally authorised medicinal product starts with the publication date in the Community register of medicinal products for human use of the European commission. Thus, not the issuing of the marketing authorisation is crucial …