OpenLegislation

Paragraph 13

Original text. Later amendments are not shown.

A summary of pharmaceutical data in respect of—

(a)

the method of manufacture or assembly of the medicinal product,

(b)

the procedures and methods employed and specifications used in the process of manufacture or assembly to ensure the uniformity of each medicinal product (together with evidence of the stability of the medicinal product and of its bio-availability for the use intended), and

(c)

the methods to be employed during manufacture for determining the identity, purity and potency of the medicinal product (together with the address of the premises where such processes are to be carried out).