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Q Are medicine tablets in a drum being sent to the EU for packaging considered to be "in the finished state and intended for the final user" and therefore exempted from Article 1(5)a of the CLP Regulation?
Yes they are. According to Directive 2001/83/EC on the Community code for medicinal products for human use, medicine tablets are medicinal products and exempted from the provisions of the CLP Regulation if they are in the finished state. The finished state of the medicinal product relates to the substance or mixture and not to its package since re-packing the tablets does not alter the substance/mixture.Bulk tablets that will not be altered after having been produced are therefore considered in the finished state intended for the final user. Therefore, it is neither necessary to classify, label and package these bulk tablets according to CLP nor to notify them to the C&L inventory.
However, it will be necessary to take worker health and safety considerations into account to ensure the safe handling of these bulk tablets during the transfer and packaging stages, until they reach the final user in the appropriate package with appropriate safe use instructions.
Date de modification: 08/08/2019
Topic: CLP
Scope: Scope and exemptions under CLP
ID: 0179
Version: 1.0
This answer has been agreed with national helpdesks.

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