Since the Medicinal Products Act (AMG) came into force in 1978, all medicinal products have been subject to compulsory marketing authorisation; their pharmaceutical quality, clinical efficacy and safety are determined by the marketing authorisation. All medicinal products that were already on the market at that time were called "old medicinal products", which were considered to be "fictitiously" authorised if the pharmaceutical entrepreneur had notified the medicinal product to the competent authority within the first six months of 1978.

This fictitious authorisation expired on 30 April 1990 if no application for renewal of the medicinal product had been submitted by then. In a processing procedure called "Nachzulassung", these medicinal products, which were already on the market, were reviewed according to the regulations of the AMG and the special regulations of Section 105 et seqq. AMG, which were effective at that time. The” Nachzulassung” of the numerous "old medicinal products" was completed on 31 December 2005.

The medicinal products that had received a positive renewal notification according to Section 105 AMG have since been subject to the same regulations of the AMG as the regularly authorised medicinal products.

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