EAEU rules of Good Distribution Practice (GDP) were adopted by the Decision of the Council of the Eurasian Economic Commission (EEC) No. 80 of November 3, 2016, while their entry into force was postponed for 18 months. The transition period allowed distributors and manufacturers of medicinal products to prepare for the enforcement of the new rules.
The document regulates all stages in the circulation of drugs and pharmaceutical substances along the product distribution chain from warehouses of manufacturers to pharmacies. The aim of the Good Distribution Practice is to ensure compliance with the proper conditions of storage, transportation and distribution required to maintain quality, safety and efficacy of drugs, as well as the exclusion of counterfeit medicinal products from EAEU market.
In this regard, the document established mandatory metrological control of the temperature regime at the sale stages and introduced the concept of “responsible person” whose competence will include the establishment and maintenance of distributor’s quality system, processing of reclamations and product recalls. This person will also make decisions about the approval of suppliers and perform several other functions.
In addition, the document established a system of bilateral audits, including both the audits of distributor by the manufacturer and the audits of manufacturer by the distributor.