Wholesale Distribution of Medicinal Products - Obligation to Notify Changes

Recommendation

13/14 December 2022

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Any person who engages in the wholesale trading of medicinal products in Germany requires an authorisation to do so, in accordance with Section 52a (1) of the Medicinal Products Act (Arzneimittelgesetz – AMG). Pursuant to Section 52a (2) No. 1 AMG, in submitting the application, the applicant must name the specific sites, as well as the activities and the medicinal products for which the authorisation is to be issued. Section 52a (8) AMG stipulates an obligation to notify changes. Accordingly, the authorisation holder must notify the competent authority in advance of any changes in the information provided in the application, as well as any fundamental change in the wholesale trading activity, submitting evidence to that effect.

A wholesaler from Brandenburg, Germany, apparently did not comply with this notification obligation, as a GDP Non-Compliance Report published in October 2021 shows.

The competent authority, the Department of Occupational Health and Safety, Customer Protection and Health, writes in the report published in the EudraGMDP database that the company was no longer at the approved premises. "The non-compliance was obvious in scheduling the regular inspection of the company. The company changed its address without information to or inspection of the competent authority."

As a consequence,"the suspension of the wholesale trade licence was ordered and trading was prohibited."

Source: EudraGMDP Database (Inspection Date: 12 May 2015; Report Number: G3-6300.GH_Rowi-Med_20210816) *

* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.