Примери за използване на Sectoral annex на Английски и техните преводи на Български
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Colloquial
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Medicine
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Ecclesiastic
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Ecclesiastic
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Sectoral Annex.
It will be responsible for the effective functioning of this Sectoral Annex.
The Sectoral Annex.
The applicable legislative, regulatory andadministrative provisions related to this Sectoral Annex are set out in the Table.
This Sectoral Annex.
Both Parties may decide by common arrangement to extend the application of this Sectoral Annex to the aforementioned medical devices.
This Sectoral Annex.
The confidence-building period will be reviewed after two years commencing from the date this Sectoral Annex, as amended, becomes effective.
This Sectoral Annex each Party.
Exchanging information and notifying the Parties of modifications of legislative, regulatory andadministrative provisions referred to in the Sectoral Annexes including those which require modification of the Sectoral Annexes; .
The Sectoral Annex on medical devices is replaced by the following.
The lists of official inspection services related to this Sectoral Annex have been jointly determined by the Parties and will be maintained by them.
Each Sectoral Annex shall, in general, contain the following information.
Such specific requests may cover information on training, inspection procedures, general information and document exchange, andtransparency of agency audits of official inspection services relevant to the operation of this Sectoral Annex.
The provisions of this Sectoral Annex will apply to the following products.
The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory andadministrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.'.
Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee.'.
The Parties shall exchange information concerning the implementation of the legislative, regulatory andadministrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement.
The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following.
The Parties jointly declare their intention to extend the scope of this Sectoral Annex to in vitro diagnostic devices as soon as New Zealand's new legislation concerning medical devices is in place.
For the purpose of this Sectoral Annex, the contact points for any technical question, such as exchange of inspection reports, inspector training sessions, technical requirements, will be.
The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility and specified in the Sectoral Annexes comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex. .
The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in Australia and the European Community, and to which Good Manufacturing Practice(GMP) requirements apply.
Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to manage a risk posed by a product covered by a Sectoral Annex, it shall notify immediately the other Party of the measures, with a brief indication of their objective and rationale, oras otherwise specified in the Sectoral Annex.'.
For medicinal products covered by this Sectoral Annex, each Party will recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.
For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification(equivalent to Qualified Person certification in the European Union).
Conformity assessment bodies to be designated for the purposes of this Sectoral Annex will meet the requirements of the Directives listed in Section I, taking into account Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, and be designated on the basis of the procedures defined in the Annex to this Agreement.