Document ID: chunk:federal_register_of_legislation:F2020L00369:clause:1_5
Version: federal_register_of_legislation:F2020L00369
Segment Type: clause
Provision Reference: sch 1 cl 5
Character Range: 4274–5491

5  Circumstances for multi-site licence—manufacture of therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue
 (1) This section applies to the manufacture of therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue.
 (2) A licence may cover two or more manufacturing sites where all of the following paragraphs apply:
 (a) steps in the manufacture of the therapeutic goods are to be carried out at one fixed site, and any additional site or sites are to be used for carrying out the following steps:
 (i) the storage of primary packaging materials, starting materials, in-process materials or finished product; or
 (ii) the secondary packaging of finished product; or
 (iii) the release for supply of packaging materials, starting materials, in-process materials, or finished product; and
 (b) all steps in the manufacture of the therapeutic goods are to be covered by a single quality system; and
 (c) all sites are capable of being inspected within the relevant period; and
 (d) all sites are located with sufficient proximity such that the total travel time between the sites under inspection does not exceed 60 minutes.