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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 …

Does Section 42b AMG also apply to the currently still "fictively licensed" medicinal products? Date: 20. June 2012 Topics: Licensing Type: FAQ

Medicinal products that are deemed to be authorised for marketing as defined by Section 105 sub-section 1 AMG, are generally subject to all provisions of the AMG, i.e. the specifications of Section 42b sub-section 2 AMG and the corresponding …

How are biosimilars viewed with regard to the reporting obligation in accordance with Section 42b AMG? Date: 20. June 2012 Topics: Licensing Type: FAQ

Medicinal products licensed as biosimilar require confirmatory clinical trials in order to obtain a marketing authorisation. Therefore, these are to be submitted in accordance with Section 42b sub-section 1 AMG. Clinical trials with licensed …

Do the statements on test or reference investigational products have to include all dose strengths used or is it sufficient to enter a medicinal product with one dose strength standing for all strengths? Date: 20. June 2012 Topics: Licensing Type: FAQ

Different dose strengths also have different marketing authorisation numbers; therefore, linkage in the Drug Information System makes it necessary to list all strengths.

As a rule, there are several marketing authorisation numbers for centralised marketing authorisations per product and/or dose strength. Can the marketing authorisation numbers be entered as numerical series (e.g.: EU/1/04/xxx/005 – 008) in such cases or does each marketing authorisation number have to be entered individually and completely? Date: 20. June 2012 Topics: Licensing Type: FAQ

Currently, it is not possible to enter numerical series in the web portal for technical reasons; therefore, all marketing authorisation numbers have to be listed individually.

How is a clinical trial evaluated that was started prior to marketing authorisation but completed after granting of the marketing authorisation? Date: 20. June 2012 Topics: Licensing Type: FAQ

If the medicinal product was licensed at any time during the clinical trial, a result report in accordance with Section 42b sub-section 2 AMG is to be submitted. This also applies if the medicinal product was not yet licensed at the time the …

If a medicinal product was licensed before 1 January 2011, the transitional regulation pursuant to Section 145 AMG applies, i.e. the pharmaceutical entrepreneur must transmit the result reports at the latest by 1 July 2012 if the medicinal product is placed on the market in Germany. What is to be done if the marketing is stopped prior to 1 July 2012? What is to be done if marketing is resumed after 1 July 2012? Date: 18. June 2012 Topics: Licensing Type: FAQ

As already stated above, the publication obligation in accordance with Section 42b sub-section 1 AMG applies to medicinal products that are on the market; this is also true for Section 145. If a medicinal product is not (or no longer) being …

If a medicinal product was licensed after 1 January 2011, does the pharmaceutical entrepreneur generally have to submit the result reports in accordance with Section 42b sub-section 1 AMG for publication within 6 months if it is placed on the market in Germany? If, for example, the pharmaceutical entrepreneur does not place the newly licensed medicinal product on the market until after 12 months, does he have to submit the result report immediately, i.e. at the same time or which time-limits apply? Date: 18. June 2012 Topics: Licensing Type: FAQ

The publication obligation in accordance with Section 42b sub-section 1 AMG applies to medicinal products that are on the market. However, Section 42b sub-section 1 AMG links the deadline for submission to the time of licensing. If a medicinal …

How is a medicinal product the marketing authorisation of which has been suspended dealt with in accordance with Section 42b sub-section 1 AMG? Date: 18. June 2012 Topics: Licensing Type: FAQ

It is against the law to place a medicinal product on the market if its marketing authorisation has been suspended. Thus, there is also no legal obligation to submit result reports pursuant to Section 42b AMG and/or Section 145 AMG during the …

Do pharmaceutical entrepreneurs always have to market all pack sizes licensed? Date: 15. June 2012 Topics: Licensing Type: FAQ

No.

What must be considered both when submitting notifications of variations of the pack sizes as well as notifications of variations of primary packaging? Date: 15. June 2012 Topics: Licensing Type: FAQ

When changing the pack size (addition or deletion), the type of immediate packaging material to which this change refers always has to be stated concurrently. Vice versa, if the type of immediate packaging material is altered (removal of …