Примери за използване на Essential requirements referred to in article на Английски и техните преводи на Български
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(a) failure to satisfy the essential requirements referred to in Article 3;
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include evidence of conformity with the essential requirements referred to in Article 6.
(a) failure to comply with the essential requirements referred to in Article 3;
Member States shall communicate to the Commission the texts of their national standards as referred to in paragraph 1(b)which they regard as complying with the essential requirements referred to in Article 3.
(a) failure to satisfy the essential requirements referred to in Article 3;
The common technical regulation shall include the harmonised standard prepared by the relevant standardisation body implementing to the extent applicable the essential requirements referred to in Article 5(g) of Directive 98/13/EC.
(a) failure to satisfy the essential requirements referred to in Article 3;
Certificates shall be issued upon application, where the applicant has demonstrated that it complies with the rules established by the delegated acts adopted pursuant to Article 47 to ensure compliance with the essential requirements referred to in Article 45.
Failure to satisfy the essential requirements referred to in Article 3;
Common technical regulations under Directive 98/13/EC whose references have been published in the Official Journal of the European Communities may be used as the basis for a presumption of conformity with the other relevant essential requirements referred to in Article 3.
(a)failure to meet the essential requirements referred to in Article 3;
Standards under Directive 73/23/EEC or89/336/EEC whose references have been published in the Official Journal of the European Communities may be used as the basis for a presumption of conformity with the essential requirements referred to in Article 3(1)(a) and Article 3(1)(b).
Member States shall presume compliance with the essential requirements referred to in Article 3 of appliances and fittings when they conform to: .
Pressure equipment and assemblies which conform to the national standards transposing the harmonized standards the reference numbers of which have been published in the Official Journal of the European Communities shall be presumed to conform to the essential requirements referred to in Article 3.
The declaration shall be made when the essential requirements referred to in Article 45 and the corresponding detailed rules established in accordance with Article 47 to ensure compliance with these essential requirements are complied with.
Devices other than those which are custom made or intended for clinical investigations considered to meet the essential requirements referred to in Article 3 must bear the EC mark of conformity.
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices designed and manufactured in conformity with common technical specifications drawn up for the devices in List A of Annex II and, where necessary, the devices in List B of Annex II.
(c)the special detailed technical specifications necessary when the design features of a particular aerodrome or the experience in operation render any of the certification specifications referred to in point(a) inadequate orinappropriate to ensure conformity with the essential requirements referred to in Article 29.
Where a Member State orthe Commission considers that conformity with a harmonised standard does not ensure compliance with the essential requirements referred to in Article 3 which the said standard is intended to cover, the Commission or the Member State concerned shall bring the matter before the committee.
The special detailed technical specifications necessary when the design features of a particular aerodrome or the experience in operation render any of the certification specifications referred to in point(a) of this paragraph inadequate orinappropriate to ensure conformity with the essential requirements referred to in Article 33.
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been publishes in the Official Journal of the European Communities;
Those attestations shall be issued upon application, when the applicant has demonstrated that he orshe complies with the rules established by delegated acts adopted pursuant to Article 25 to ensure compliance with the essential requirements referred to in Article 19 on theoretical knowledge, practical skill and medical fitness.
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union;
Where apparatus meets the relevant harmonised standards or parts thereof whose reference numbers have been published in the Official Journal of the European Communities,Member States shall presume compliance with those of the essential requirements referred to in Article 3 as are covered by the said harmonised standards or parts thereof.
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union;
Organisations responsible for the provision of groundhandling services and AMS at aerodromes subject to this Regulation shall declare their capability, andthe availability to them of the means, to discharge the responsibilities associated with the services provided in compliance with the essential requirements referred to in Article 33.
Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 do not entirely meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Directive►M4 98/34/EC(9)◄, giving the reasons therefor.
Member States shall presume conformity with the essential requirements referred to in Article 3 in respect of instruments which comply with the relevant national standards implementing the harmonized standards that meet the essential requirements referred to in Article 3.
Where a Member State or the Commission considers that the harmonized standards referred to in Article 5(2)do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Committee set up under Directive 83/189/EEC, giving the reasons therefor.
Member States shall presume compliance with the essential requirements referred to in Article 3 of products referred to in Article 1(1) which meet the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Communities;