BfArM - Federal Institute for Drugs and Medical Devices

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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 …