Sample dispatch and sample delivery

A Swiss company with a wholesale license was looking for new solutions in connection with the dispatch of pharmaceutical samples and the drafting of internal guidelines for the distribution of samples to pharmacies and drugstores.

We supported the company in choosing a transport service provider and drew up contracts to ensure that the transport complied with Good Distribution Practice (GDP) and that the medicines were not damaged.

Together, we drew up internal guidelines (Standard Operating Procedure, SOP) that set out simply and clearly the quantities in which specialist and public samples can be dispensed to drugstore and pharmacy specialists in accordance with the provisions of the Ordinance on the Advertising of Medicinal Products (AWV). This has enabled the company to simplify its processes and ensure that samples are dispensed in accordance with Swiss law.

Successfully mastering inspections (GxP)

A provider of therapeutic products services contacted Pharmalex GmbH as part of its periodic basic inspection. We supported them in the legal classification of the Swissmedic guidelines and technical interpretation as well as the GMP and GDP requirements of Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This enabled us to jointly harmonize the GMP and GDP requirements with the existing quality management system.

We advise with pragmatic solutions tailored to specific needs.

From A to B via CH

International pharmaceutical distribution

An internationally active pharmaceutical company based in Switzerland handles the Europe-wide distribution of its medicinal products from Switzerland. It was necessary to clarify the conditions under which direct deliveries between EU countries with administrative processing via Switzerland are possible and which authorizations are required for this. All players in the pharmaceutical supply chain must comply with the principles of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) in order to protect patients from falsified medicinal products entering the legal supply chain. With our experience in Swiss and European pharmaceutical law and in matters relating to bilateral agreements (Mutual Recognition Agreement, MRA), we were able to contribute to the design of the distribution structure.