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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.

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 …

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 …

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 …