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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.

Template issued by the European Commission for the qualified person’s declaration on GMP comlpiance Date: 14. January 2014 Topics: Licensing Type: News

A new Template issued by the European Commission for the qualified person’s declaration on GMP compliance

Can an adaptation of the texts to be in line with the current QRD templates be submitted together with Type 1A or Type IAIN variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

It is possible to submit an adaption of the texts together with Type IA or Type IAIN variations. This change is classified as a Type IB variation with the change category C.I.z. which is subject to fees. This classification is a grouping of a …

How is the adaption to the model texts published by the BfArM to be submitted? Date: 11. December 2013 Topics: Licensing Type: FAQ

Following the recommendation pursuant to Article 5 of the Variation Regulation, the adaption to the model texts should be classified as variation C.I z.

C.I.z Change(s) in the SmPC, labelling or package leaflet of human …

Can an implementation of the explanatory statements on additional monitoring and ADR reporting be submitted together with Type 1A or Type IAIN variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

It is possible to submit the implementation of the explanatory statements on additional monitoring and ADR reporting together with Type IA or Type IAIN variations. This change is classified as a Type IAIN variation with the change category C.I.z. in …

Under which classification category can adaptation of the texts (SmPC/PIL/labelling) to conform with the excipient guidelines be submitted as a national variation? Date: 11. December 2013 Topics: Licensing Type: FAQ

Adaptions of texts to conform with the excipient guidelines (changes in the SmPC and corresponding PIL/labelling) are to be submitted as variations Type IB classification category C.I.z.

According to the general grouping rules, a text adaptation to …

How should an update of the texts in line with the current QRD templates be submitted in the absence of any further changes to the product information? Date: 11. December 2013 Topics: Licensing Type: FAQ

If only the adaption of the texts in order to be in line with the current QRD template without any further changes (a single variation) is submitted, this is considered to be a Type IB variation with a change category C.I.z. for which fees will …

Under which classification category can adaptation of the texts (SmPC/PIL/labelling) to conform with the MedDRA terminology be submitted as a national variation? Date: 11. December 2013 Topics: Licensing Type: FAQ

Adaptions of texts to conform with the MedDRA terminology (changes in the SmPC and corresponding PIL/labelling) are to be submitted as a variations Type IB classification category C.I.z.

According to the general grouping rules, a text adaptation to

How should the implementation of the explanatory statements on additional monitoring and adverse drug reaction (ADR) reporting be submitted in Type IB or Type II variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

If the implementation of the explanatory statements on additional monitoring and ADR reporting is submitted in addition to a Type IB or Type II variation of change category C, this should be stated clearly in the cover letter and under “Precise scope …

How should the implementation of the explanatory statements on additional monitoring and ADR reporting be submitted in the absence of any further changes to the product information? Date: 11. December 2013 Topics: Licensing Type: FAQ

If only the implementation of the explanatory statements on additional monitoring and ADR reporting without any further changes (a single variation) is submitted, this is considered to be a Type IAIN with variation a change category C.I.z. in …

How should an adaptation of texts in line with QRD templates be submitted in the context of Type 1B or Type II variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

If an update of the texts in line with the QRD templates (labelling, PIL and SmPC) is submitted in addition to a Type IB or Type II variation, this should be stated clearly in the cover letter and under “Precise scope and background for change” in …

Counterfeits, quality defects, batch recalls (Rapid Alert System) Date: 02. December 2013 Topics: Licensing Type: Article

Here you will find the reporting form for pharmaceutical entrepreneurs for transmission of quality issues, batch recalls and counterfeits to the competent authority as well as the e-mail contact list of the nationally competent health authorities …

Can I create file names arbitrarily or which rules need to be followed? Date: 08. October 2013 Topics: Licensing Type: FAQ

There is a file naming convention: German text versions need to be named in the following manner in the fixed part:
Packungsbeilage-paldeff-var.pdf;
Fachinformation-spcdeff-var.pdf

The English version should be named the same way:

Do I need to comply with the 3-week deadline if an objection has been raised? Date: 08. October 2013 Topics: Licensing Type: FAQ

No. The BfArM will check against entries in the respective database and will set the requirement on hold until the case has been finalised.

Do I need to consider any specifics on format or layout of the PDF version of the file? Date: 08. October 2013 Topics: Licensing Type: FAQ

The PDF files will be published without additional formatting or correction by the BfArM. Therefore, you should not send versions with tracked changes mode, containing comments or annotations, with headers or footers indicating the text as …

Do I need to submit texts in German and English in all cases? Date: 08. October 2013 Topics: Licensing Type: FAQ

For all procedures you have to submit the “Packungsbeilage” and “Fachinformation”, i.e. the German version of the authorised product information texts if they exist (paldeff-var.pdf; spcdeff-var.pdf). In case of decentralised or mutual …

Does the BfArM require submission of the same files using the same naming convention with an eCTD or NeeS sequence? Date: 08. October 2013 Topics: Licensing Type: FAQ

No, this is not required. The nationally translated product information texts and the text version as authorised after end of the procedure regardless of the language are not part of the eCTD or NeeS dossiers. The only purpose of the requested …

Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping? Date: 23. September 2013 Topics: Licensing Type: FAQ

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective …

Is it possible to use the EU Electronic Application Forms (eAF) alternatively? Which signature is required in this case? Date: 23. September 2013 Topics: Licensing Type: FAQ

EU Electronic Application Forms can definitively be used as an alternative. In this case, the scanned signature will be accepted in any format, as the authorisation procedure which is part of the PharmNet.Bund and/or CESP portal is considered an …

Will a purely electronic submission for national or European Variations via the PharmNet.Bund portal together with an upload via CESP be possible for documents which do not comply with the requirements for eCTD or NeeS? Date: 23. September 2013 Topics: Licensing Type: FAQ

Basically, yes. However, the BfArM strongly recommends switching to the eCTD or NeeS formats, as only structured submissions like with eCTD ensure that the processing is as smooth and resource-sparing as possible.