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A.1. Is it possible to apply for an extension? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. The time frame in accordance with Section 31 sub-section 1 number 1 AMG (Arzneimittelgesetz, German Medicines Act) is a statutory period. Therefore, no extension is possible.

C.2. Are e.g. long processing times of the national competent authority or pending appeal procedures and court actions reasons for granting an exemption if the 3-year period is exceeded for such reasons but the medicinal products cannot be marketed due to these pending procedures? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. However, a suspension of the 3-year period can be applied for in such cases (for more information cf. Item A.5.).

C.4. Is an exemption granted if the authorised medicinal product from an MR / DC procedure with Germany as RMS has not/no longer been on the German market for more than three consecutive years, but is required in at least one CMS? Date: 09. September 2008 Topics: Licensing Type: FAQ

Such exemptions can be granted on a case-by-case basis provided the necessary requirements have been fulfilled. Together with the application, the marketing authorisation holder has to prove specifically that the medicinal product is authorised …

A.2. Is it sufficient to make a binding declaration within the 3-year period that the medicinal product will be placed on the market again? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. The law requires that the medicinal product is marketed within the statutory period.

A.4. What happens if submitted applications for exemption pursuant to Section 31 sub-section 1 sentence 2 AMG do not become legally binding within the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG? Date: 09. September 2008 Topics: Licensing Type: FAQ

In the case of pending or not legally effective applications for exemption pursuant to Section 31 sub-section 1 sentence 2 AMG, marketing authorisations do not expire until a legally binding decision has been made. In cases of a legally …

C.3. Can exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG also be granted for "third countries"? Date: 09. September 2008 Topics: Licensing Type: FAQ

Exemptions in accordance with Section 31 sub-section 1 sentence 2 AMG can also be granted for export to a third country for public health reasons. The same criteria as for national public health protection apply to the granting of such …

B.1. When is a medicinal product considered marketed? Date: 09. September 2008 Topics: Licensing Type: FAQ

The term "marketing" is defined in Section 4 sub-section 17 AMG as follows: "Marketing is the keeping in stock for sale or for other forms of supply, the exhibiting and offering for sale and the distribution to others".

It is the BfArM's view that a …

B.3. Does the administration of medicinal products in clinical trials constitute marketing as defined in the AMG? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, medicinal products used in clinical trials can also fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG.

D.2. Do notifications also have to be made for medicinal products for which marketing authorisation has been applied for but which are not yet licensed in accordance with Section 105 (so-called fictively licensed medicinal products)? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with Section 105 sub-section 1 AMG these medicinal products are considered licensed. Section 105 sub-section 3a AMG defines the exemptions to Section 29 AMG. As these Sections do not include any specifications concerning the …

D.8. Does the obligation to notify the national competent authority in accordance with Section 29 sub-sections 1b, 1c AMG via PharmNet.Bund application "Notifications for Sunset Clause" also apply to products for which either standard marketing authorisation or standard registration procedures are used? Date: 09. September 2008 Topics: Licensing Type: FAQ

No, when employing standard marketing authorisation or standard registration procedures no notifications have to be made via PharmNet.Bund application “Notifications for Sunset Clause”. Informations on the use of products for which either standard …