1.The manufacturer shall retain sufficient samples of each batch of bulk formulated product, of key packaging components used for each finished investigational medicinal product batch and of each batch of finished investigational medicinal product for at least two years after the completion or discontinuation of the last clinical trial in which the batch was used.
Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained by the manufacturer for at least two years after the release of the investigational medicinal product. However, this period may be shortened where the period of stability of the starting material, as indicated in the relevant specification, is shorter.
In all cases samples shall be maintained by the manufacturer at the disposal of the competent authority.
2.Upon application of the manufacturer, the competent authority may grant a derogation from paragraph 1 in relation to the sampling and retention of starting material and for certain products manufactured individually or in small quantities, or when their storage could raise special problems.