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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

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Other aspects of the product (that are not being changed)

Generally, only the requested change(s) will be reviewed at the time of application. However, some changes naturally impact on other aspects of the product which may require further clarification. If a problem is detected which is unrelated to the requested change, it may be followed up as a separate issue, but will generally not hold up processing of the application.

Sponsors should be aware that sometimes a proposed change might involve additional consequential changes (e.g. removal of a colouring agent may also require change to visual identification). In such cases, each of the relevant changes should be specified in the application.

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