Vaxneuvance

Batch Release Testing and Compliance

• It is a condition of registration that all independent batches of Vaxneuvance vaccine imported into Australia are not released for sale until samples and the manufacturer's release data have been assessed and sponsor 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 QC[quality control], including all steps in production in the agreed format.
  • At least 20 (twenty) vials (samples) of each manufacturing batch of Vaxneuvance vaccine with the Australian approved labels, PI [Product Information] and packaging (unless an exemption to supply these has been granted) representative of all batches of product seeking distribution in Australia.
  • At least 5 (five) vials (samples) of any further consignments of a manufacturing batch of Vaxneuvance vaccine with the Australian approved labels, PI and packaging (unless an exemption to supply these has been granted). Further consignments cover batches previously supplied to TGA for the purposes of batch release testing but are seeking to be supplied again.
  • If the manufacturing batch has been released in Europe or United Kingdom [UK] a copy of the EU [European Union] Official Control Authority Batch Release (OCABR) certificate (or equivalent from the UK) must be provided.
  • Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.

  Sponsors must provide all requested samples and data in sufficient time (at least five business days) prior to any distribution date to allow the TGA to perform testing and review. Distribution of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.

• Samples and data should be forwarded to the Biotherapeutics Section, Laboratories Branch before release of each batch and with sufficient lead time to allow for Laboratories Branch testing.
• The shipments (including reagents) to TGA are the responsibility of the Australian sponsor/agent who will be required to facilitate the import and customs clearance process.

Certified Product Details

• 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.
• The Vaxneuvance EU[European Union]-risk management plan (RMP) (version 0.1, dated 2 November 2020, data lock point 16 September 2020), with Australian specific annex (version 0.1, dated 01 December 2020), included with submission PM-2020-06364-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

Vaxneuvance (Pneumococcal 15-valent conjugate vaccine [CRM197 protein], adsorbed) is to be included in the Black Triangle Scheme. The PI and CMI [Consumer Medicines Information] for Vaxneuvance must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product. 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 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.