Technical review of the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods
Call for submissions
This consultation closed on 6 February 2009.
The Therapeutic Goods Administration (TGA) invites submissions from interested parties to help inform a technical review of the document Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (pdf,170kb) <http://www.tga.gov.au/docs/pdf/tepcop.pdf> (TEP Code of Practice).
Background
The TEP Code of Practice was published by the TGA in June 2003 on behalf of the Industry Government Crisis Management Committee (IGCMC). It was based on an earlier industry guideline document, Guideline for the Tamper-Evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices (December 2000). The December 2000 guideline and subsequently the TEP Code of Practice were developed as part of a suite of strategies aimed at preventing, or minimising the effect of, product tampering incidents involving therapeutic goods.
The TEP Code of Practice was written with a view to it being adopted as a mandatory packaging standard for those therapeutic goods falling within the scope of the document. This action however was delayed pending establishment of the proposed but now postponed joint regulatory scheme for therapeutic products with New Zealand.
The Therapeutic Goods Committee <http://www.tga.gov.au/docs/html/tgc.htm> (TGC) has recommended <http://www.tga.gov.au/docs/html/tgc/tgc31.htm#tep> subsequently that, as the TEP Code of Practice is central to the introduction of any mandatory requirement for TEP but is now some years old, a review of the technical content of the Code of Practice should be undertaken before any further consideration is given to the adoption of the Code of Practice as a mandatory packaging standard.
The TGC noted in particular that sponsors of therapeutic goods should now have considerable experience in application of the Code of Practice and that in the years since its publication, it was likely that new packaging solutions would have been developed.
The technical review of the TEP Code of Practice is being undertaken for the TGC by its expert Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use <http://www.tga.gov.au/docs/html/tgc/tgc31.htm#tg>.
Information sought
The TEP Code of Practice provides information on those therapeutic goods that should have tamper-evident packaging (TEP), requirements for TEP, acceptable tamper-evident features, validation and accompanying label statements advising of the TEP feature(s) present on the pack.
The TGC Subcommittee is seeking input on a number of aspects of the TEP Code of Practice and, to assist stakeholders in providing this, has developed the following explanatory material and specific questions for consideration.
Scope
The TEP Code of Practice currently states, under "Scope", that it applies to "therapeutic goods including medical devices that are unscheduled or in Schedule 2 or Schedule 3 of the Poisons Standard which are administered transdermally, ingested orally or come into contact with the mucous membranes". It then states that dentifrices, lozenges, essential oils, topical preparations for local effect, preparations in pressurised aerosol containers, and the primary packs of first aid kits are exempted from the requirements of the Code of Practice. A number of explanatory notes are included, and it is highlighted that prescription products supplied only through hospitals or which are stored in a pharmacy dispensary are not required to be packaged in tamper-evident packaging.
- Do you consider that the scope of the Code of Practice is adequate?
- If not, how would you like to see the scope changed? If you consider that the scope should be extended in any way, please provide your reasons.
- Do you consider that clarification of the information contained in this section of the Code of Practice is needed?
- If so, please indicate what aspects you would like to see clarified.
Requirements
The TEP Code of Practice requires that TEP be used for all products that fall within its scope. The general requirements given are that:
- tamper-evident features must be designed to remain intact when handled in a reasonable manner during manufacture, distribution and retail display; and
- a tamper-evident feature must not obscure or destroy any mandatory label information.
The Code then differentiates between two-piece capsules, which require a minimum of two tamper-evident features and corresponding statements on the package, and other dosage forms, which require a minimum of one tamper-evident feature and a corresponding statement on the package.
- Do you consider that the any further distinctions between product types and/or dosage forms should be made?
- If yes, please indicate what distinctions you consider would be justified and give reasons.
- Noting that all tamper-evident features described in the Code of Practice are currently regarded as equal, should any limitations be applied to the use of any particular tamper-evident features with specific product types and/or dosage forms?
- If yes, please describe what limitations you would consider to be justified, and why.
Tamper-evident features
The TEP Code of Practice shows a number of packaging features which are considered to be acceptable forms of TEP provided their use is properly validated. Whilst the forms of TEP shown are those that were most commonly in use at the time of original publication, the Code of Practice advises that these forms of TEP should not be seen as excluding other types of TEP or precluding technological innovation.
- Noting the purpose of TEP is to alert the consumer to possible tampering, are there any tamper-evident technologies currently in commercial use that have been omitted?
- If yes, please provide information on the particular technologies, their area of application and the extent of current usage.
Validation
The TEP Code of Practice provides information on general validation principles and requirements for TEP. It identifies specific design considerations, requirements for clear and concise specifications, validation procedures, in-process testing and documentation requirements.
- Do you consider that the validation section of the TEP Code of Practice requires amendment - for example, are any significant matters not covered, or are there any errors or areas that need clarification?
- If so, please provide details and suggestions for this amendment.
Submissions
Submissions providing information on any of the above questions, or other matters that will help inform the review of the technical content of the TEP Code of Practice are invited.
While submissions providing opinion only will be accepted, those of most value will be supported by examples, relevant data or reference to technical specifications.
Note - this call for submissions relates only to a review of the technical content of the Code of Practice. Submissions are NOT being sought at this time on the question of whether the Code of Practice should become a mandatory packaging standard for therapeutic goods.
What will happen to submissions?
Submissions will be used by the TGC and its expert subcommittee to inform the technical review of the TEP Code of Practice. Reference to the submissions and a summary of their content may be posted on the internet.
Confidentiality
If you wish any information contained in your submission to be treated as confidential, please clearly identify that information and outline the reasons why it is confidential.
Further information
Any questions in relation to this matter should be directed to the Secretary of the Therapeutic Goods Committee on telephone number 02 6232 8661 or by email to standards@tga.gov.au.