Which of the following is NOT required to be included in a marketing application?

The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?