Verorab

• Verorab is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Verorab 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.
• The Verorab EU [European Union] -risk management plan (RMP) (version 2.1, dated 3 March 2020, data lock point 1 January 2020), with Australia specific annex (version 1.0, dated 30 July 2021), included with Submission PM-2021-03191-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

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.

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 (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

• The sponsor must not import or supply the product without compliance with the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines, or without a relevant exemption.
• As agreed by the sponsor, the details of the manufacturing processing and purification steps with viral clearance capacity, or any validation studies using model viruses according to Section 6.1.1 of ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] Q5A (R1) and CPMP /BWP/268/95 [Committee for Proprietary Medicinal Products] must be provided by the end of 2023.
• All GMP [Good Manufacturing Practices] clearances must be approved prior to registration and supply of product to Australia. A commitment is required from the sponsor that they maintain the validity of all manufacturer GMP Clearances for the duration of product supply to Australia. Additionally, that adherence to the conditions of GMP clearance approval is upheld.
• Additional data relating to the ongoing stability study for the concentrated bulk drug substance will be submitted
• It is a condition of registration that all independent batches of Verorab vaccine 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 QC [Quality Control], including all steps in production in the agreed format.
• At least 5 (five) vials (samples) of each manufacturing batch of Verorab vaccine with the Australian approved labels, PI and packaging (unless an exemption to supply these has been granted) representative of all batches of product seeking distribution in Australia.
• At least 1 (one) vial (samples) of any further consignments of a manufacturing batch of Verorab 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 a copy of the EU 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 5 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.

• For all injectable products the Product Information must be included with the product as a package insert