Release decision

The decision on whether a manufactured lot may be shipped. Japan splits it into two decisions. Under the GMP Ministerial Ordinance, the site's quality department decides whether the lot may leave the manufacturing site; PMDA's English materials call the related written procedure batch disposition. Under the GQP Ordinance (Article 9, control of market release), the marketing authorization holder then decides whether the product may be released to the Japanese market. For a foreign site, your release is the first of these two steps. Ask the MAH what it needs from you, and by when, to make its market release decision.