BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.

  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

430 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

How is sentence 2 of Section 145 AMG: "Sentence 1 is applicable to clinical trials subject to Sections 40 to 42 in force as of 6 August 2004" to be understood? Date: 20. June 2012 Topics: Licensing Type: FAQ

Based on the modifications in Section 145 sentence 2 AMG, the transitional regulations only apply to those clinical trials that were subject to an authorisation by the competent higher federal authority.

If the clinical trial was performed in Germany but the sponsor is located in another non-European country, does the legal representative have to submit the result report in accordance with Section 42b sub-section 2 AMG? Date: 20. June 2012 Topics: Licensing Type: FAQ

The provision of Section 42b sub-section 2 AMG is directed at the sponsor of a clinical trial. The legal representative of the sponsor assumes the legal responsibility if the sponsor he represents does not fulfil his obligations. Therefore, it …

Does Section 42b AMG affect clinical trials with registered traditional medicinal products? Example: A clinical trial in accordance with Sections 40 to 42 is/was performed with a medicinal product registered pursuant to Sections 39a to d AMG, e.g. in order to gain a renewal of the marketing authorisation. However, the marketing authorisation is then either not granted or it is not applied for due to the results of the study. Date: 20. June 2012 Topics: Licensing Type: FAQ

In Germany, clinical trials with homoeopathic or registered traditional herbal medicinal products are subject to authorisation in accordance with Section 42 AMG. However, result reports pursuant to Section 42b AMG are only to be submitted for …

Can a CRO enter the data in the name of the marketing authorisation holder/sponsor? Date: 20. June 2012 Topics: Licensing Type: FAQ

Yes, any person (including a CRO) thus commissioned by the marketing authorisation holder (Section 42b sub-section 1 AMG) or sponsor (Section 42b sub-section 2 AMG) can submit the data.

How is the situation with clinical trials the data of which were not yet available during the licensing procedure and are subsequently not contained in the licensing documentation, but which were completed before the marketing authorisation was granted? Do the provisions of Section 42b AMG even apply to these studies, and if so, those of sub-section 1 and/or those of sub-section 2? Date: 20. June 2012 Topics: Licensing Type: FAQ

Since the obligation to submit the entire licensing documentation is subject to criminal sanction, this constellation should only occur in very few cases. If a clinical trial was not confirmatory for marketing authorisation and had also been …

Both confirmatory studies of the pharmaceutical entrepreneur and treatment studies are submitted for an extension of indication. Does the obligation in accordance with Section 42b sub-section 1 and Section 42b sub-section 2 AMG result in duplicate reporting since the product is already licensed? Date: 20. June 2012 Topics: Licensing Type: FAQ

Yes, clinical trials with a licensed medicinal product as the investigational product can entail reporting obligations pursuant to Section 42b sub-section 1 as well as to sub-section 2 AMG, if the clinical trial is also confirmatory for a …

Who is responsible for the submission of the result report if the marketing authorisation holder is located in the EU and the medicinal product is marketed by a different pharmaceutical entrepreneur in Germany – the marketing authorisation holder or the pharmaceutical entrepreneur who places the medicinal product on the market in Germany? Date: 20. June 2012 Topics: Licensing Type: FAQ

In accordance with Section 4 sub-section 18 AMG any natural or legal person who places a medicinal product on the market in Germany under his own name is a pharmaceutical entrepreneur. Thus, the obligation pursuant to Section 42b sub-section 1 …

What if the competent higher federal authority has not yet assigned a processing number ("Einreichungsnummer", ENR) for a centralised license. Can it be omitted in that case? Date: 20. June 2012 Topics: Licensing Type: FAQ

No, the ENR is necessary so that result reports that are submitted in accordance with Section 42b sub-section 1 AMG can be allocated to the appropriate medicinal product in the PharmNet.Bund system. If the ENR is not known to the pharmaceutical …

How are clinical trials with medicinal products that are licensed but not being marketed dealt with in accordance with Section 42b sub-section 2 AMG? What if the marketing authorisation is likewise suspended during the study? Date: 20. June 2012 Topics: Licensing Type: FAQ

Section 42b sub-section 2 AMG applies only to the licensing but not to the marketing of a medicinal product. Consequently, the obligations laid down in Section 42b sub-section 2 AMG are fully applicable. Thus, the corresponding reports are to …

In the case of multinational multicentric trials – do all centres have to be listed in the result report or only the German centres? Date: 20. June 2012 Topics: Licensing Type: FAQ

The information on where and in which study population the trial was conducted is very important for understanding and evaluating the results of clinical trials and is therefore – according to the ICH E3 Guideline – a fundamental part of the …