Over-labelling - Any requirements or best-practices?

M

Mark Meer

Trusted Information Resource
Situation: Our manufacturer address changes. Because the large stock of labels, packaging, and printed manuals that all have the old address, we are considering over-labelling (applying a label with the new address over the old address, but otherwise other labelling content is unaffected). A few questions:

1. Are there regions where this practice is specifically prohibited?

2. Are there any regulations/guidances to be aware of?

3. Over-labelling would be handled under a rework order. From a documentation-control perspective, given that the entire stock of existing labelling would be over-labelled, is it acceptable that the revision level (e.g. on the front cover of the IFUs) is unchanged given that the content is technically now different due to the over-label?
 
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