Online sales register and EU security logo

Notification obligation from 26 October 2015

From 26 October 2015 anyone who wishes to trade in medicinal products for human use will have to notify the competent authority of this in advance. This obligation applies to online pharmacies and medicine retailers alike and irrespective of whether medicinal products are sold which require a prescription or not. In addition to the name or company name of the pharmacy/retailer, the authority must be notified of all websites on which the medicinal products are to be offered as well as the address of the place from which the products are to be delivered.

Every online pharmacy/retailer must also be registered in the “online sales register” kept by the German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information (DIMDI)).

The websites of the online pharmacy/retailer must state the name, address and the “other contact details” of the competent authority, as well as the EU security logo linking the website of the pharmacy/retailer with the DIMDI website. Prospective customers can by clicking on the logo find out whether the pharmacy/retailer is authorised to sell medicinal products online. The compulsory EU logo will replace the logo offered to date by DIMDI on a voluntary basis.

In addition to the German register, each EU and EEA Member State has its own national register with the pharmacies/medicine retailers located there. A list is available on the website of the European Medicines Agency (EMA): List of pharmacies/medicine retailers

As long as the online pharmacy/medicine retailer fails to satisfy its obligations, it is prohibited from selling human medical products use online. This may result in regulatory measures, sanctions and/or warning letters.

Legal basis

The relevant rules are Sec. 67(8) and Sec. 146(11) of the German Medicines Act (AMG). Both provisions have been included in the AMG with the Second Act to Amend Medicines Act and Other Provisions of 19.10.2012 (Federal Legal Gazette I, p. 2192). They implement Article 85c of the Human Medicines Directive (EC Directive 2001/83) as amended by EU Directive 2011/62. The obligation to use the European security logo and to meet the standards for presentation of the logo also result directly from the Implementing Regulation (EU) No. 699/2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity (OJ EU L 184/5 of 25.6.2014).

Further information is available on the websites of the DIMDI and of the Federal Ministry of Health:

https://www.dimdi.de/static/de/amg/versandhandel/index.htm