The wholesale distribution of medicinal products is under European Union regulation as an important activity in the integrated supply chain management. The quality and the integrity of medicinal products can be affected by a lack of adequate control. To this end, the European Union Commission has published guidelines on Good Distribution Practice of medicinal products for human use in the form of a Commission guideline 2013/C 343/01
PHOENIX already maintains a unique compliance portfolio including certifications ISO-9001:2008, ISO-14001:2004, AEO, IATA Accredited Agent and Business Ethics Code. The latest addition to this portfolio by end November 2016 is GDP Compliance Management Accreditation for Ambient and Cold Chain Temperature controlled transport of Medicinal Products and APIs, as well as for DGP Audit.
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient.
Today’s distribution network for medicinal products is increasingly complex and involves many players. GDP guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
Guidelines introduce the following:
- the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
- suitable documentation which prevents errors from spoken communication;
- sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
- adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
- appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
- outsourced activities correctly defined to avoid misunderstandings;
- rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
- Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products).
Wholesale distribution of medicinal products is “all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned”.
Source:
http://ec.europa.eu/health/human-use/good_distribution_practice/developments_en
