Paragraph 37
Where the licence holder sells or supplies special medicinal products F1or EAMS medicinal products, the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—
(a)
the batch number of the batch of the product from which the sale or supply was made; and
(b)
details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.
Annotations
Textual amendments
- F1
Words in Sch. 4 para. 37 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(6) (with reg. 19)