RUS/101
WTO/TBT
RU Russland
  • 11 - Medizintechnik
  • 30 - Pharmazeutische Erzeugnisse
2020-09-22
2020-07-28

Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3004)

The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union (30 page(s), in Russian)

The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union applies to medicinal products put into circulation on the territory of the Eurasian Economic Union and envisages the need to establish a unified approach to the procedures for qualification and validation of medicinal products, in order to prove that the parameters of critical processes (equipment) meet the specified requirements, as well as in case of significant changes in premises, equipment and processes that may affect the quality of finished products, which makes it possible to ensure stable output of products with a given level of quality at pharmaceutical enterprises.