All references in this Chapter to technical regulations, standards and conformity assessment procedures shall be construed to include any amendments. Pursuant to Article 5.2.5 of the TBT Agreement, any conformity assessment fees charged by a Party shall be limited to the approximate cost of services rendered. A Party may determine the form of proposals for technical regulations and conformity assessment procedures, which may take the form of: policy proposals;.
Each Party shall notify proposals for new technical regulations and conformity assessment procedures which are consistent with the technical content of applicable international standards, guides or recommendations, if any, and which may have a significant effect on trade, according to the procedures established pursuant to Article 2.9 or 5.6 of the TBT Agreement.
Cooperation and Trade Facilitation
With regard to the mechanisms referred to in paragraphs 1 and 2, the Parties recognize that the choice of the appropriate mechanism in a given regulatory context depends on a variety of factors, such as the product and sector concerned, the volume and direction of the trade, the relationship between the Parties' respective regulators, the legitimate objectives pursued and the risks of failure to achieve those objectives. Following Article 2.7 of the TBT Agreement, a Party shall, at the request of another Party, explain the reasons why it has not accepted a technical regulation of that Party as equivalent.
Information Exchange and Technical Discussions
Committee on Technical Barriers to Trade
In determining what activities the Committee will undertake, the Committee will take into account the work being undertaken in other forums in order to ensure that any activities undertaken by the Committee do not unnecessarily duplicate that work. The Committee shall meet within one year from the date of entry into force of this Agreement and thereafter as decided by the Parties.
Contact Points
Annexes
A Party may require the Supplier to ensure that any statement required by that Party to be affixed to a wine or distilled spirits label is: a) clear, precise, true, accurate and not misleading to the consumer; and. If the Party requires the supplier to provide information on the distilled spirit label, the Party shall allow the supplier to provide this information on an additional label affixed to the distilled spirit container. Each Party shall permit a supplier to affix an additional label to a container of imported distilled spirits after importation, but before the product is offered for sale in the territory of the Party, and may require the supplier to affix an additional label prior to customs clearance.
The contracting party may request the supplier to provide additional information on the type, category, class or classification of the wine on the wine label. The Contracting Party accepts all information that appears outside of a single field of vision, if this information is in accordance with the laws, regulations and requirements of the Contracting Party. The Party allows the Supplier to confirm. additional mark on the packaging of imported wine after import but before the product is offered for sale in the territory of the Party and may require the supplier to affix the additional mark before customs clearance.
No party shall require a supplier to indicate any of the following information on a container, labels or packaging for wine or distilled spirits: a) date of manufacture or manufacture. No party shall require a supplier to place a translation of a trademark or trade name on a wine or distilled spirit container, label or packaging. 8 Nothing in this paragraph shall be construed as requiring Canada to apply this paragraph in a manner inconsistent with its obligations under Article A, paragraph 3, in Annex V to the wine agreement between the EU and Canada, as amended.
Nothing in this paragraph shall be construed as requiring Malaysia to apply this paragraph in a manner inconsistent with Regulation 18(1A) of the Food Regulations 1985 under the Food Act 1983. Where a Party requires a supplier to provides a sample of the product for the Party's procedure for assessing conformity with its technical regulation or standard, it shall not require a sample quantity exceeding the minimum quantity necessary to complete the relevant conformity assessment procedure.
PHARMACEUTICALS
When developing or implementing regulations for marketing authorization of pharmaceutical products, each Party shall consider relevant scientific or technical guidance documents developed through international cooperative efforts. Each Party will make its decision whether to grant marketing authorization for a specific pharmaceutical product on the basis of: a) information, including, if appropriate, pre-clinical and clinical data, on safety and efficacy;. Each Party shall administer any marketing authorization process it maintains for pharmaceutical products in a timely, reasonable, objective, transparent and impartial manner, and shall identify and manage any conflicts of interest in order to mitigate any associated risks. a) Each Party shall provide an applicant requesting marketing authorization for a pharmaceutical product with its determination. within a reasonable period of time.
The Parties acknowledge that the reasonable period of time required to determine marketing authorization may be affected by factors such as the novelty of the product or regulatory implications that may arise. If a Party determines that an application for a marketing authorization for a pharmaceutical product under review in its jurisdiction has deficiencies that have or will lead to a decision to refuse its marketing, that Party shall notify the applicant requesting a marketing authorization and shall state the reasons why the application is deficient. For greater certainty, a Party may maintain an appeal or review process that is either an internal regulatory body responsible for determining the marketing authorization, such as a dispute resolution process or review, or an external regulatory body.
Neither Party shall require that a pharmaceutical product obtain marketing authorization from a regulatory authority in the country of manufacture as a condition for the product to obtain marketing authorization from that Party. For greater certainty, a Party may accept a prior marketing authorization that has been issued by another regulatory authority as evidence that a product can meet its requirements. If there are regulatory resource constraints, a Party may require that a marketing authorization from one of a number of reference countries be established and made public by that Party as a condition of marketing authorization of the product by that Party.
COSMETICS
Neither Party shall implement separate marketing authorization procedures or sub-procedures for cosmetic products that differ only in terms of shade extensions or fragrance variants, unless the Party determines that there is a significant concern for human health or safety. Each Party shall manage all marketing authorization processes it maintains for cosmetic products in a timely, reasonable, objective, transparent and impartial manner and shall identify and manage potential conflicts of interest in order to minimize any associated risks. If a Party applies for a marketing authorization for a cosmetic product and finds that an application for a marketing authorization for a cosmetic product under review in its jurisdiction has deficiencies that have or will lead to a marketing refusal decision, that Party shall notify the applicant for a traffic permit and states the reasons why the application is deficient.
If a Party maintains a marketing authorization process for cosmetic products, that Party shall consider replacing that process with other mechanisms, such as voluntary or mandatory notification and post-market surveillance. When developing regulatory requirements for cosmetic products, the Contracting Party shall take into account its available resources and technical capabilities to minimize the implementation of requirements that could: a) inhibit the effectiveness of procedures for ensuring the safety or quality of the manufacture of cosmetic products; or b) causes significant delays in the issuance of a marketing authorization for cosmetic products for sale on the market of this Party. Neither Party shall require the submission of marketing information, including regarding prices or costs, as a condition for obtaining marketing authorization for a product.
Neither Party shall require that a cosmetic product be labeled with a marketing authorization or notification number. 17. Neither Party shall require that a cosmetic product obtain marketing authorization from a regulatory authority in the country of manufacture as a condition for the product to obtain marketing authorization from the Party. For greater certainty, this provision does not prevent a Party from accepting a prior marketing authorization issued by another regulatory authority as evidence that a product can meet its requirements.
MEDICAL DEVICES
When developing or implementing regulations for marketing authorizations for medical devices, each Party shall take into account relevant scientific or technical guidance documents developed through international cooperative efforts. Each party must make a decision on whether to issue a marketing authorization for a specific medical device on the basis of:. a) information, including, if relevant, clinical data, on safety and efficacy. Each Party shall administer any marketing authorization process it maintains for Medical Devices in a timely, fair, objective, transparent and impartial manner and identify and manage any conflicts of interest to mitigate any associated risks. (a) Each Party shall provide its decision to an applicant requesting a marketing authorization for a medical device within a reasonable period of time.
The parties acknowledge that the reasonable period required to determine marketing authorization may be affected by factors such as the novelty of the device or regulatory implications that may arise. If a Party determines that an application for a marketing authorization for a medical device under review in its jurisdiction has deficiencies that have or will lead to a decision to refuse its marketing, that Party shall notify the applicant requesting a marketing authorization and shall state the reasons why the application is deficient. When developing regulatory requirements for medical devices, the Contracting Party shall take into account its available resources and technical capabilities to minimize the implementation of requirements that could: a) inhibit the effectiveness of procedures to ensure the safety, efficiency or quality of manufacturing of medical devices; or b) causes significant delays in issuing a marketing authorization for medical devices for sale on the market of that Party.
Neither Party shall require a medical device to obtain a marketing authorization from a regulatory authority in the country of manufacture as a. For greater certainty, a Party may accept a prior marketing authorization that has been issued by another regulatory authority as evidence that a medical device can meet its requirements. If there are regulatory resource constraints, a Party may require a marketing authorization from one of a number of reference countries established and made public by that Party as a condition for that Party's marketing authorization of the medical device.
ORGANIC PRODUCTS