_ EEC. Moscow, 27 April 2018.
The Rules are an important part of the quality assurance system of medicines in the common market of the Eurasian Economic Union (EAEU) and apply to all those involved in their commercialization, including manufacturers and distributors.
The document regulates all stages in the circulation of pharmaceuticals and pharmaceutical substances along the distribution chain – from manufacturers’ warehouses to pharmacies. Its objective is to ensure compliance with the proper conditions of storage, transportation and distribution required to maintain quality, safety and efficiency of medicines as well as the prevention of counterfeit pharmaceuticals from coming on the EAEU market.
The Rules have been developed on the basis of the documents of the World Health Organization.
They define a number of approaches to the organization of medicines distribution in the Union, which will allow tracking their circulation and ensuring the continuity of the distributor’s responsibility for maintaining the declared quality of pharmaceuticals. In this regard, the mandatory metrological control of the temperature regime at the sale stages is established, and the concept of “responsible person” is introduced, whose competence will include the establishment and maintenance of the distributor’s quality system, processing of reclamations and product recalls. This person will also make decisions on the approval of suppliers and perform several other functions.
In case of any reclamation, it will be necessary, according to the Rules, to analyze the entire supply chain from the manufacturer to the end user.
In addition, a system of bilateral audits is established, including both audits of the distributor by the manufacturer and audits of the manufacturer by the distributor.
Such compliance with the established requirements will allow controlling the entire supply chain of medicines, preserving their quality and integrity and providing millions of citizens of the EAEU countries with medicines, the quality and efficiency of which will not be damaged in the process of delivery from manufacturers to patients.
The EAEU Rules of Good Distribution Practice (GDP) wereadopted by the Decision No. 80 of the Council of the Eurasian EconomicCommission (EEC) dated November 3, 2016 [СМВ1], the use of which was suspended for 1.5 years. This transition period allowed pharmaceutical distributors and manufacturers to prepare for the application of this new document.