Importers are manufacturing-authorisation holders and so the obligations under Article46f/50f of Directive 2001/83(2) apply to them. For importers, the possibilityof a second-party audit performed by the third-country manufacturer that usesthe active substance as a starting material may be a further option.

Importers arealready obliged to ensure that the third-country manufacturer complies with standards of GMP equivalent to those of the European Community and should have established arrangements in line with chapter 7 of the GMP guideline . They should therefore be fully satisfied that the third-country manufacturer has adequately demonstrated that theactive substances it uses for products destined for the European Community have been manufactured in accordance with GMP.

Importers may of course choose to verify the standards of GMP at the active-substance suppliers themselves or through a third party. Whichever option is chosen, the questions and answers above are also relevant.

进口商属于生产许可持有人，所以也需要承担法令2001/83(2)第46f/50f条规定的义务。对于进口商而言，可以由使用活性物质作为起始物料的第三国生产商进行第二方审计。

进口商有义务保证第三国生产商符合的GMP等同于欧盟GMP标准，且应按GMP指南第7章要求实施。因此他们应该要求第三国生产商充分证明销往欧盟的制剂所用的活性物质生产完全符合GMP要求。

当然，进口商也可以选择亲自去原料药生产商那里确认GMP标准，或者通过第三方审计。不管选择哪一种方式，上述问答都是适用的。