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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 …

For submissions made via the PharmNet.Bund portal, how can a CESP submission number for a variation already sent be amended, in case a new CESP upload including a new CESP submission number becomes necessary due to an incorrect initial CESP submission? Date: 14. August 2014 Topics: Licensing Type: FAQ

The PharmNet.Bund “Online Variation Submission” application offers the possibility of sending a request for correction. For this purpose you have to select the option “list sent notifications” from “Work list” under “Notification sent”. From this …

Explanatory Notes Sunset Clause PDF, 2MB, File is accessible Date: 31. July 2014 Topics: Licensing Type: Download

Explanatory Notes Sunset Clause

Information on the use of medicinal products containing thalidomide, lenalidomide or pomalidomide, in clinical trials Date: 29. July 2014 Topics: Licensing Type: News

Section 3a of the Ordinance on the Prescription of Medicinal Products ("Arzneimittelverschrei­bungsverordnung", AMVV) of 21 December 2005 (BGBl. I p. 3632) as last amended by Article 1 of the Ordinance of 19 February 2013 (BGBl. I p. 312) …

Should we always take the actual version of the reference texts for an adaptation of the product texts according to C.I.2, or is it possible to use this variation category for a subsumption into one variation for several updates of the reference text? Date: 02. July 2014 Topics: Licensing Type: FAQ

We refer to the following Q/A of the CMDh :

Question 4.14
How can a generic MA be adapted to the most current version of the SmPC, if the results of several procedures, e.g. PRAC/ PhVWP recommendations and PSUR worksharing, have to be considered?

Update of BfArM eValidator (Software for technical validation of e-submissions) Date: 24. April 2014 Topics: Licensing Type: News

The BfArM is issuing an updated version of the eValidator (version 5.2.1.01) and kindly requests all users to update the version they are currently using accordingly.

In many cases only the wording for the SmPC is provided for the adoption of standard texts according to C.I.3. How can the consequential change in the package leaflet be applied for? Date: 07. April 2014 Topics: Licensing Type: FAQ

The change in the package leaflet can be applied for together with the change in the SmPC in one variation application.
The following Art. 5 recommendation is applicable, that a type IB variation is required for these cases:

C.I.3.z29.07.2013

How should the adaption of the product information to an updated Company Core Data Sheet (CCDS) be applied for? Date: 24. March 2014 Topics: Licensing Type: FAQ

When adapting product informations to updated CCDS, each change aspect which triggers an update in the CCDS should be mentioned in the scope of the application form and should be classified according to the variation guideline.
The identified change …

Processing Statistics of the BfArM 2013 PDF, 135KB, File does not meet accessibility standards Date: 17. March 2014 Topics: Licensing Type: Download

State: March 2014

Can statement of the expiry date in the labelling of investigational medicinal products (IMP) be omitted when using IVR/IWR systems (IVRS: Interactive Voice Response System, IWRS: Interactive Web Response System)? Date: 14. March 2014 Topics: Licensing Type: FAQ

Yes, but only in specific circumstances.

As a rule, this is only possible in case of clinical trials in which the IMPs are exclusively administered by the personnel at the investigator site and are not dispensed to the volunteers.

Furthermore, the …

Is it allowed to group minor notifications of type IA category A + B + C in one application without any relation to each other? Date: 23. January 2014 Topics: Licensing Type: FAQ

All minor notifications of type IA and type IAIN may be grouped in one application without any relation to each other, if the group includes only type IA and type IAIN.