Distribution procedures
Article 44
1. Active substances and intermediates thereof shall only be released for distribution to third parties after they have been released by the quality unit. 2. Active substances and intermediates thereof can be transferred under quarantine to another unit under the manufacturer’s control when authorised by the quality unit and if appropriate controls and documentation are in place. 3. Active substances and intermediates thereof shall be transported in a manner that does not adversely affect their quality. 4. Special transport or storage conditions for an active substance or intermediate shall be stated on the label. 5. In case of outsourced activities as referred to in Chapter XVI, the manufacturer (‘contract giver’) shall ensure that adequate information is transmitted to the contractor (‘contract acceptor’) for the performance of the outsourced activities and that the contract acceptor follows the appropriate transport and storage conditions. 6. A system shall be in place by which the distribution of each batch of intermediate or active substance can be traceable to permit its recall.