Marketing
B.1. When is a medicinal product considered marketed?
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 prerequisite for marketing is that the batch released medicinal product is marketed within the purview of the German Medicines Act. Thus, the export of the blistered tablets alone, for example, does not constitute a marketing of the licensed medicinal product as defined in Section 31 sub-section 1 sentence 1 number 1 AMG.
B.2. Does the term 'marketing' include the dispensing of free physicians’ samples supplied by pharmaceutical entrepreneurs?
Yes. Since samples supplied by pharmaceutical entrepreneurs can be dispensed to physicians on the basis of Section 47 sub-section 4 AMG, they are also considered marketed within the definition of the AMG.
B.3. Does the administration of medicinal products in clinical trials constitute marketing as defined in the AMG?
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.
B.4. Is the export of medicinal products also considered marketing?
Yes, generally the export of medicinal products can fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG. A precondition for this is that the batch release of the licensed medicinal product also has taken place within the purview of the AMG. Thus, the export of the blistered tablets alone, for example, does not constitute a marketing of the licensed medicinal product as defined by Section 31 sub-section 1 sentence 1 number 1 AMG. In this connection, the export refers only to the German marketing authorisation. However, from the BfArM's point of view, linguistic adaptation of the presentation as well as of the informative texts is possible.
If the medicinal product licensed in Germany is exported in accordance with the a.m. requirements, thus fulfilling the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG, no exemption pursuant to Section 31 subsection 1 sentence 2 AMG is necessary.
B.5. When does the sunset clause ticker start counting in Germany?
As a matter of principle, the end of the shelf-life of the batch last placed on the market by the marketing authorisation holder is counted.
B.6. When is the competent authority to be notified of the placing on the market?
In accordance with Section 29 sub-section 1b AMG, the marketing authorisation holder shall notify the competent federal higher authority immediately of the date on which the medicinal product is to be placed on the market, taking into consideration the different pharmaceutical forms and strengths authorised.
In this connection, the term “immediately“ means that the authority is to be notified when the company has internally specified the precise date for placing the medicinal product on the market and not when it is actually placed on the market; however, the notification should be made no earlier than 4 weeks prior to placing on the market. Failure to notify the authority in due time constitutes an administrative offence in accordance with Section 97 sub-section 2 number 7a AMG.