Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.

The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

It is a condition of registration that all independent batches of Flucelvax Quad imported into Australia are not released for sale until samples and the manufacturer's release data have been assessed and you have received notification acknowledging release from the Laboratories Branch, TGA.

For each independent batch of the product imported into Australia, the sponsor must supply the following:

• A completed Request for Release Form, available from vaccines@health.gov.au.
• Complete summary protocols for manufacture and quality control (QC), including all steps in production.
• At least 20 (twenty) doses of the first consignment of each batch of Flucelvax Quad with the Australian approved labels, PI and packaging.
• At least 10 (ten) doses of any further consignment of each batch of Flucelvax Quad with the Australian approved labels, PI and packaging and at least 20 (twenty) doses of any further consignment of each batch of Flucelvax Quad with the Australian approved labels, PI and packaging.
• Certificate of Release from a regulatory agency acting for the country of origin such as an Official Medicines Control Laboratory (OMCL) (if available).
• Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.

Distribution of each shipment of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.

An electronic copy of the Certified Product Details (CPD) as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) should be provided upon registration of the therapeutic good. In addition, an updated CPD, for the above products incorporating the approved changes is to be provided within one month of the date of approval letter. A template for preparation of CPD for biological prescription medicines and Vaccines can be obtained from the TGA website. The CPD should be sent as a single bookmarked PDF document to vaccines@health.gov.au as soon as possible after registration/approval of the product or any subsequent changes as indicated above.