by the negotiators of the Trans-Pacific Partnership

“ If a Party requires marketing authorisation for a cosmetic product, the Party shall ensure that any marketing authorisation determinations are subject to an appeal or review process that may be invoked at the request of the applicant seeking market authorisation. For greater certainty, the Party may maintain an appeal or review process that is either internal to the regulatory body responsible for the marketing authorisation determination, such as a dispute resolution or review process, or external to the regulatory body. ”

“ Where a Party requires a manufacturer or supplier of a medical device to indicate information on the product’s label, the Party shall permit the manufacturer or supplier to indicate the required information by relabeling the product or supplementary labelling of the product in accordance with the Party's domestic requirements after importation but prior to offering the product for sale or supply in the Party’s territory. ”

“ Further to paragraph 7, each Party shall, when regulating cosmetic products, take into account that cosmetic products are generally expected to pose less potential risk to human health or safety than medical devices or pharmaceutical products. ”

“ Each Party shall administer any marketing authorisation process it maintains for pharmaceutical products in a timely, reasonable, objective, transparent, and impartial manner, and identify and manage any conflicts of interest so as to mitigate any associated risks. ”

“ No Party shall require a supplier to disclose an oenological practice on a wine label or container except to meet a legitimate human health or safety objective with respect to the relevant oenological practice. ”

“ A Party shall publish, preferably by electronic means, any procedures, criteria and other conditions that it may use as the basis for determining whether conformity assessment bodies are competent to receive accreditation, approval, licensing, or other recognition including where such recognition is granted pursuant to mutual recognition agreements. ”

“ The Parties shall seek to collaborate through relevant international initiatives, such as those aimed at harmonization, as well as regional initiatives in support of such international initiatives, as appropriate, to improve the alignment of their respective pharmaceutical products regulations and regulatory activities.
6. Each Party shall consider relevant scientific or technical guidance documents developed through international collaborative efforts with respect to pharmaceutical products when developing or implementing regulations for marketing authorisations of pharmaceuticals products. ”

“ Further to Article 9.1 of the TBT Agreement, a Party shall consider adopting provisions to approve conformity assessment bodies that hold accreditation for the technical regulations or standards of the importing Party with an accreditation body that is a signatory to an international or regional mutual recognition arrangement. [1] Parties recognise that such arrangements can address the key considerations in approving conformity assessment bodies, including technical competence, independence, and the avoidance of conflicts of interest. ”

“ No Party shall require animal testing for determining the safety of cosmetic products, unless there is no validated alternative method available to otherwise assess safety. A Party may, however, consider the results of animal testing in determining the safety of a cosmetic product. ”

“ No Party shall require that a cosmetic product receive marketing authorisation from the country of manufacture, as a condition for the product receiving marketing authorisation from the Party. For greater certainty, this provision does not prohibit a Party from accepting a prior marketing authorisation issued by another regulatory authority as evidence that a product may meet its own requirements. ”

“ Where a Party prepares or adopts good manufacturing practice guidelines for cosmetic products, it shall use relevant international standards for cosmetic products, or the relevant parts of them, as a basis for its guidelines except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued. ”

“ Where certification of wine is deemed necessary by a Party to protect human health and safety or to achieve other legitimate objectives, that Party shall consider the Codex Alimentarius Guidelines for Design, Production, Issuance and Use of Generic Official Certificates (CAC/GL 38-2001) , in particular the use of the generic model official certificate, as amended from time-to-time, concerning official and officially recognised certificates. ”

“ Each Party shall permit suppliers to place lot identification codes on wine and distilled spirits containers, provided that they are clear, specific, truthful, accurate and not misleading. Each Party may impose penalties for the removal or deliberate defacement of any lot identification code provided by the supplier and placed on the container. ”

“ Recognising that each Party is required to define the scope of products covered by this Annex pursuant to paragraph 2, for purposes of this Annex, a pharmaceutical product may include a human drug or biologic that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or condition in humans or intended to affect the structure or any function of the body of a human. ”

“ The Parties shall endeavour to resolve the matter as expeditiously as possible, recognising that the time required to resolve a matter will depend on a variety of factors, and that it may not be possible to resolve every matter through technical discussions. ”