b) On the acknowledgement of the other Parties, given in writing, the body will be considered as notified and as competent to assess conformity in relation to the requirements specified in the annexes from that date.

(b) on the acknowledgement of the other Party, given in writing, the body shall be considered as notified and as competent to assess conformity in relation to the said requirements specified in the Annexes from that date;

5.1 Members shall ensure that, in cases where a positive assurance of conformity with technical regulations or standards is required, their central government bodies apply the following provisions to products originating in the territories of other Members:

For this purpose the Contracting Party may stipulate an initial verification, consisting of a check on and confirmation of the conformity of a new or repaired device with the type-approved model and/or with the requirements of this annex and its appendices or may delegate the power to certify to the manufacturers or to their authorized agents.

The approval authority of a Contracting Party granting a type approval pursuant to a Regulation annexed to this Agreement must verify the existence of adequate arrangements and documented control plans, to be agreed with the manufacturer for each approval, to carry out at specified intervals those tests or associated checks necessary to verify continued conformity with the approved type, including, specifically, where applicable, tests specified in the said Regulation.

that should not affect the obligation on manufacturers to affix the CE mark to certain constituents in order to certify their compliance with other Community legislation relating to them.

Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.

Member States shall ensure that official inspections are carried out in relation to the marketing of seed of oil and fibre plants, at least by random checks, to verify compliance with the requirements of this Directive.

The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if the value of overall migration determination implies that the specific migration limits referred to in that paragraph are not exceeded."

whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory-production control system under the responsibility of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required;

whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsibility of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required;

when it has been unable to confirm compliance with the requirements in Articles 4 and 5;

The conformity assessment procedures identified in this Article shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements identified in Article 3.

Whereas the confirmation of compliance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer;

Whereas the checks on conformity and the ensuing clearance decisions will therefore no longer be linked to the implementation of the budget in a particular financial year;

That does not affect the obligation on manufacturers to affix the CE marking to certain components in order to certify their compliance with other Community provisions relating to them.

in derogation from Sections 1, 2, 5 and 6, the verifications conducted by the notified body are intended to confirm the conformity of the products in Class IIa with the technical documentation referred to in Section 3 of Annex VII.

The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if the value of overall migration determination implies that the specific migration limits referred to in that paragraph are not exceeded."

This Regulation should lay down all the rules necessary for implementing Article 896 of Regulation (EEC) No 2454/93. In some cases it should be possible to comply with Regulation (EEC) No 2454/93 without recourse to the confirmation referred to in Article 880 thereof.

It will be guided in its task by the need to set out the phases of preparatory work, and the components of a GMP compliance and two-way alert programme against which reconfirmation of equivalence will take place taking into account the previous experiences.

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex; and,

the term 'competent authority' means an authority of a party with the power to conduct inspection or study audits on facilities in its territory to confirm their compliance with the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party;

These batches shall be accompanied by the EC type-examination certificate referred to in Article 10, or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in Annex II section 3. In this case the approved body shall, prior to EC verification, examine the schedule in order to certify its conformity.,

For the type-approval and verification of production of vehicles of category M1 equipped with an engine whose capacity > 1 400 cm3, the technical service may, at the request of a manufacturer, carry out the equivalent test described in Annex IIIA (EPA cycle) instead of that described in 5.2.1.1.

As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I under the normal conditions of use of the device and the evaluation of the undesirable side-effects must be based on clinical data in particular in the case of implantable devices and devices in Class III.

Each party may request the other party, by indicating in writing a reasoned doubt on whether a registered conformity assessment body or a confirmed facility complies with the criteria for designation or the criteria for confirmation set out in the applicable laws, regulations and administrative provisions specified in the relevant Sectoral Annex, respectively, to conduct verification of the conformity assessment body or the facility in accordance with the laws, regulations and administrative provisions of that other party.

- technical specifications, rules or codes of practice concerning those types of security devices for which there do not exist at Community level technical specifications, classification systems, rules, procedures or codes of practice harmonised in line with Community legislation covering the free movement of goods, and procedures for assessing and approving the compliance of security devices with such specifications, rules or codes of practice,

With respect to Article 2(2) of this Agreement, each party shall, as a result of the acceptance of the confirmation of test facilities by the competent authorities of the other party, accept the data for a test item generated by the confirmed test facilities as equivalent to the data generated by its own test facilities which are confirmed to be compliant with the principles of GLP, taking into account the equivalence of GLP compliance monitoring programme of both parties, which are consistent with the OECD Council Decision-Recommendation of 2 October 1989 (C(89)87 (final)) as amended by the OECD Council Decision of 9 March 1995 (C (95) 8 (final)), provided that:

With respect to Article 2(2) of this Agreement, each party shall, as a result of the acceptance of confirmation of manufacturing facilities carried out by the competent authorities of the other party, accept, regarding the medicinal products for which its marketing authorisation has been issued or for which product specifications are applicable, the certificate issued by the confirmed manufacturing facilities of the conformity of each batch to the marketing authorisation or product specifications and exempt the importers from the testing of each batch, in accordance with the laws, regulations and administrative provisions of each party specified in the Section I of Part B of this Sectoral Annex, taking into account the equivalence of GMP requirements of both parties, provided that:

whereas such conformity must be certified by the affixing of a European mark;

In some cases it should be possible to comply with Regulation (EEC) No 2454/93 without recourse to the confirmation referred to in Article 880 thereof.

Methods for testing the characteristics of driving licences for the purpose of confirming their compliance with the international standards shall be in accordance with ISO 10373.

The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant:

The results of the measurements made to verify compliance with the emission limit values shall be standardised at the following conditions:

The notified body shall determine and perform, or arrange for the performance of, the appropriate inspections and tests to certify the conformity of the types of material with the corresponding requirements of this Directive;

that should not affect the obligation on manufacturers to affix the CE mark to certain constituents in order to certify their compliance with other Community legislation relating to them.

EEC initial verification constitutes the examination of a new or reconditioned instrument and the confirmation of its conformity to the approved pattern and/or to the requirements of this Directive and the separate directives relating to the instrument in question;

Members shall ensure that, in cases where a positive assurance of conformity with technical regulations or standards is required, their central government bodies apply the following provisions to products originating in the territories of other Members:

The notified body may not require detailed plans or precise information not necessary for verifying the conformity of the lift about to be placed on the market with the model lift described in the EC type-examination declaration.

The organisation shall establish a programme for continuation training for certifying staff and category B1 and B2 support staff, including a procedure to ensure compliance with the relevant paragraphs of 145.A.35 as the basis for issuing certification authorisations under this Part to certifying staff, and a procedure to ensure compliance with Part 66.

Whereas the Digesa has provided official assurances regarding compliance with the rules set out in Chapter V of the Annex to Directive 91/493/EEC and regarding the fulfilment of requirements equivalent to those laid down by that Directive for the approval of establishments;

The procedure for certification of conformity of documents held on commonly accepted data carriers with the original document shall be laid down by the national authorities and shall ensure that the versions held comply with national legal requirements and can be relied on for audit purposes.

The manufacturer, or his authorised representative established in the Community, of equipment referred to in Article 2(1) shall, in order to certify that an item of equipment is in conformity with the provisions of this Directive, draw up an EC declaration of conformity for each type of equipment manufactured;

In order to verify that the structure complies with the requirement laid down in the second paragraph, the manufacturer or his authorised representative established within the Community must, for each type of structure concerned, perform appropriate tests or have such tests performed.

the term "competent authority" means an authority of a party with the power to conduct inspection or study audits on facilities in its territory to confirm their compliance with the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party;

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex;

These batches shall be accompanied by the EC type-examination certificate referred to in Article 10, or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in Annex II section 3. In this case the approved body shall, prior to EC verification, examine the schedule in order to certify its conformity.

For this purpose the Member States may stipulate an initial verification, consisting of a check on and confirmation of the conformity of a new or repaired device with the type-approved model and/or with the requirements of the Regulation and its Annexes, or may delegate the power to certify to the manufacturers or to their authorized agents.

In respect of veterinary medicinal products, the European Community will, subject to satisfactory verification of New Zealand's GMP inspection programme, recognise the conclusions of New Zealand GMP inspections and of New Zealand manufacturers' certifications of batch conformity, three years after the entry into force of the Agreement.

Member States must ensure it is the case and certify conformity, in accordance with the Geneva Protocol on standardisation of fresh fruit and vegetables and dry and dried fruit concluded within the United Nations Economical Commission for Europe and the OECD scheme for the application of international standards for fruit and vegetables.