Flublok Quadrivalent

An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

Unless agreed separately between the supplier who is the recipient of the approval and the Therapeutic Goods Administration (TGA), the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.

If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.

It is a condition of registration that all independent batches of Flublok Quadrivalent imported into Australia are not released for sale until samples and the manufacturer’s release data have been assessed and the sponsor has 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 twenty doses of the first consignment of each batch of Flublok Quadrivalent with the Australian approved labels, Product Information (PI) and packaging;
• at least ten doses of any further consignment of each batch of Flublok Quadrivalent with the Australian approved labels, PI and packaging and at least twenty doses of any further consignment of each batch of Flublok Quadrivalent 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 Laboratories (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.