MenQuadfi
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 December 2019 |
| First round evaluation completed | 30 April 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 29 June 2020 |
| Second round evaluation completed | 14 August 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 31 August 2020 |
| Sponsor's pre-Advisory Committee response | 15 September 2020 |
| Advisory Committee meeting | 30 September 2020 |
| Registration decision (Outcome) | 27 October 2020 |
| Completion of administrative activities and registration on ARTG | 29 October 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 183 |
*Statutory timeframe for standard applications is 255 working days
MenQuadfi should be administered as a 0.5 mL single dose injection by the intramuscular route only.
Primary Vaccination
- Individuals 12 months of age and older receive a single dose.
Booster Vaccination
- MenQuadfi may be given as a single booster dose to adolescents and adults who have previously been primed with meningococcal vaccine at least 4 years prior.
Refer to official recommendations for further information regarding booster dosing.
For further information refer to the Product Information.
MenQuadfi (meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine) was approved for the following therapeutic use:
MenQuadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. The use of MenQuadfi should be in accordance with official recommendations.
- MenQuadfi (meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for MenQuadfi 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 MenQuadfi European Union (EU)-Risk Management Plan (RMP) (version 0.2, date 6 May 2020; data lock point 15 June 2019), with Australian Specific Annex (version 1.1, dated 30 June 2020), included with submission PM-2019-04826-1-2, 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.
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 Menquadfi 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.
All batches of Menquadfi supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD). When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
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, including all steps in production.
- At least five doses* of each first consignment of product lot with the Australian approved labels, PI and packaging. Three doses* of any further consignment of already released product (including diluents) with the Australian approved labels, PI and packaging. *Number to be confirmed
- Certificate of release from any jurisdiction, for example from the country of origin, an Official Medicine Control Laboratory or equivalent (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.
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.
- 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. 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.
- For all injectable products the Product Information must be included with the product as a package insert.