The European Medicine Agency (EMA) has issued its final guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use. The guidelines were issued on March 7, 2013 registered as (2013/C 68/01).
The guidelines are based on Article 84 and Article 85(b)(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1) (Directive 2001/83/EC).
The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and involves many players. These guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products, said the regulatory authority.
According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products comprising 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.
Any person acting as a wholesale distributor has to hold a wholesale distribution authorization. Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for GDP.
Possession of a manufacturing authorization includes permission to distribute the medicinal products covered by the authority. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.
The definition of wholesale distribution does not depend on whether that distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to wholesale distribution activities such as exporting, holding or supplying also apply to these distributors. Relevant sections of these guidelines should also be adhered to by other actors involved in the distribution of medicinal products.
Other factors such as brokers may also play a role in the distribution channel for medicinal products. According to Article 85(b), persons brokering medicinal products must be subject to certain provisions applicable to wholesale distributors, as well as specific provisions on brokering.
The guidelines has also detailed the responsibility of the pharma and biotechnology industry and has tables of contents under categories such as quality management, personnel, premises and equipment, documentation, operation, complaints, suspected falsified medicines, product recalls, outsourced activities, self inspection, transport and specific provisions for brokers who are persons involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution.