Paragraph 10
The manufacturer must keep readily available for examination by a person authorised by the licensing authority samples of—
(a)
each batch of finished products for at least a period of one year after their expiry date; and
(b)
starting materials (other than solvents, gases or water) for at least a period of two years after release of the medicinal product of which those materials formed part,
except where the manufacturer is authorised by the licensing authority to destroy such samples earlier.
Notes on Schedule 9
Textual amendments
- F1
Words in Sch. 9 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(2); 2020 c. 1, Sch. 5 para. 1(1)