Revised: 30 January 2013
Consultations
Medsafe signals planned changes to packaging requirements for antidepressants
To:
Product sponsors
Applicants for new and changed medicines
Regulatory affairs consultants
This letter is to:
- signal changes to the packaging requirements for antidepressants
- provide additional advice on best practice packaging requirements for other medicines
- outline implementation and transition arrangements
- provide a contact point for queries or feedback on the proposed changes.
Background
Medsafe's interpretation of regulation 37(5) of the Medicines Regulations 1984 is that all antidepressants in solid dose form must be in safety containers. Regulation 2 defines a safety container as a blister strip.
The packaging of these medicines in safety containers is required in order to minimise accidental ingestion and overdose, particularly by children.
Advances in therapies for depression have seen the introduction of antidepressants less toxic than those listed in regulation 37(5) (e.g. selective serotonin reuptake inhibitors - SSRIs). Following requests from stakeholders, Medsafe has reviewed the packaging requirements for medicines to determine whether less toxic antidepressants may be able to be supplied in containers other than safety containers.
As part of the review Medsafe has looked closely at the current child-resistant packaging requirements for medicines in Australia. The Australian Therapeutic Goods Agency (TGA) undertakes regular review of substances and has developed TGO80 to provide guidance on what medicines are required to be in safety containers, including non-reclosable (i.e. blister strips) and reclosable containers.
Medsafe has, therefore, decided to adopt TGO80 as a best practice approach for the packaging of all medicines that present a risk to children if accidentally ingested.
Sponsors should note that TGO80 will not apply to solid dose forms of medicines specified in regulation 37 of the Medicines Regulations (including tricyclic and tetracyclic antidepressants) which must be packaged in blister strips until the definition of a safety container is amended. The exemption for paracetamol distributed as a dispensing pack remains unchanged (refer to Part 5 of the New Zealand Regulatory Guidelines for Medicines).
All other medicines detailed withinTGO80 will now be able to be supplied in non-reclosable or reclosable packaging (as defined within TGO80). Thus, adoption of TGO80 will mean that SSRI and SNRI antidepressants (which are less toxic than tricyclic or tetracyclic antidepressants) may be distributed in bottles fitted with a child-resistant closure.
Next steps
The target implementation date for the changes described above is 1 May 2013.
From this date sponsors may submit applications for SSRIs in child-resistant reclosable containers. The usual fees will apply.
From 1 May 2013 applications for consent to distribute other medicines included in TGO80 in reclosable containers will be expected to include information on child-resistant closures or a justification provided.
Sponsors who currently distribute medicines specified in TGO80 in reclosable containers should review their packaging. If child resistant closures are not used, sponsors should update their packaging at the next opportunity.
Queries about, or comments on, the changes described above should be sent to
Sarah Reader
Manager Product Regulation
Medsafe
PO Box 5013
WELLINGTON
Email askmedsafe@health.govt.nz
by Thursday 28 February 2013.
Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (www.medsafe.govt.nz). Yours sincerely
Sarah Reader
Manager Product Regulation
