Published: 20 February 2024
Amended: 2 April 2024
Compliance
Intention to submit an application for pseudoephedrine provisional consent
If you intend to apply for approval of a Pseudoephedrine cold and flu
medicine, that you will sell this cold and flu season, submit information to
Medsafe by Wednesday 28 Feb 2024.
Applicants do not need to submit an NMA until Medsafe has confirmed that products have been accepted for evaluation under the priority provisional evaluation pathway.
The government has announced that Cold and flu medicines containing pseudoephedrine will be reclassified from prescription to restricted medicines, which will allow the public to purchase these medicines from a pharmacist in a pharmacy, without a prescription.
The details of the classification will be gazetted on Thursday 22 February.
We expect that companies will be planning to submit applications for approval of medicines containing pseudoephedrine for the coming cold and flu season. We are seeking information from potential applicants that intend to submit applications for products that would be available for supply in the 2024 cold and flu season. Medsafe will consider their suitability for provisional consent and confirm whether applications for priority provisional consent should be submitted.
Products currently approved by TGA, MHRA, Health Canada or US FDA are among those considered most likely to be eligible for this priority provisional consent pathway.
Medsafe needs to plan this evaluation work taking into account other work underway. Depending on the volume of applications for pseudoephedrine products, it’s likely that we will have to restrict the number of applications accepted for evaluation under priority in this first stage.
Data requirements
To submit an NMA for evaluation under this pathway, applicants will need to provide in their NMA:
- Evidence of overseas approval
- Module 1 requirements (a full module 1 is required):
- Labels should comply with NZ requirements. Label exemptions may be considered if products with compliant labels are not available.
- A description must be provided of instances in which the current label does not meet New Zealand requirements. In these cases overlabelling should be considered.
- Labels must comply with Controlled Drug labelling requirements, refer to regulation 25 of the Misuse of Drugs Regulations 1977. Regulation 25(A) of the Misuse of Drugs regulations provides for some exemptions to this requirement.
- Current GMP certification must be provided for all sites involved in the manufacture, packing or testing of the Finished Product, in accordance with Medsafe’s Manufacture of medicines guideline.
- A NZ datasheet, prepared in accordance with Medsafe’s guideline on requirements for Information for Prescribers and Consumers. The datasheet must be based on the relevant overseas innovator safety information.
- Module 3 requirements:
- Control of API, by API manufacturer and finished product manufacturer, including specification(s) and recent batch data (not required for API controlled to a pharmacopoeia of Certificate of suitability).
- Description of the manufacturing process for the finished product including process controls (e.g., process flow chart).
- Finished Product Specifications (release and shelf-life)
- Description of analytical test methods for control of the finished product, and confirmation of validation status for in-house methods
- Three CoAs of finished product.
- Stability data, or evidence of the shelf life and storage conditions approved overseas.
Fees
The fee for provisional consent will be aligned with the fee for Provisional consent to distribute a new medicine (stock shortage); $2,130. The fee for subsequent conversion to full consent will be aligned with the fee for Provisional conversion to full approval (stock shortage); $8,176.
