natgillin/translations-raw huggingface dataset:
ČLEN 2, TOČKA 1 (A) (I A) (novo) Člen 1, odstavek 2, točka (a), pododstavek 2 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (A) (I A) (new) Article 1, paragraph 2, point (a), subparagraph 2 (Directive 93/42/EEC)
(ia) v točki (a) se drugi pododstavek nadomesti z:
(ia) in point (a), the second subparagraph is replaced by the following:
"in ki:
"and which does not:
– glavno načrtovano delovanje v človeškem telesu ali na človeško telo se ne doseže na farmakološki, imunološki ali presnovni način, ampak mu lahko ti načini pri njegovem delovanju pomagajo;
- achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
– oblika ali način, kako ga proizvajalec predstavi ali ponudi na trgu, ustvarja splošni vtis, da gre za izdelek, namenjen zdravljenju ali preprečevanju bolezni pri ljudeh;“
- by its form or the manner in which the manufacturer presents it or places it on the market, encourage in persons generally the impression that the product has medicinal properties for the treatment or prevention of disease in humans;"
(Prvi del besedila je vzet iz izvirne direktive.)
(First part of the text has been taken from the original Directive)
Varnost pacientov je treba zagotoviti.
Patient safety has to be ensured.
Razlikovanje med medicinskimi pripomočki in zdravili mora biti jasnejše.
The distinction between medical device and medicinal products must be made clearer.
Generični izdelki morajo biti razvrščeni v isto kategorijo kot izvirni.
The copy products must fall under the same category as the original one.
ČLEN 2, TOČKA 1 (A) (I A) (novo) Člen 1, odstavek 2, točka (h a) (novo) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (A) (I A) (new) Article 1, paragraph 2, point (h a) (new) (Directive 93/42/EEC)
(ia) vstavi se točka (ha):
(ia) the following point (ha) is inserted:
"(ha) 'ponovna predelava' pomeni čiščenje, razkuževanje in steriliziranje uporabljenega medicinskega pripomočka, kar vključuje s tem povezano delo ter testiranje in obnovo funkcionalne in higienske varnosti za varno ponovno uporabo."
"(ha)'reprocessing' means the cleaning, disinfection and sterilization of a used single-use medical device, including the associated work as well as the testing and restoration of the functional and hygienic safety for a safe re-use.
Pravna ali fizična oseba in/ali njen pooblaščeni zastopnik se v skladu s tem členom šteje za proizvajalca, ko ponovno predela medicinski pripomoček in ga da v promet."
The legal or natural person and/or its authorised representative shall be deemed the manufacturer in accordance with this Article when reprocessing a medical device and placing it on the market."
Glej obrazložitev predloga spremembe člena 21 (a) (novo).
See justification on amendment on article 21 (a) new.
Ta predlog spremembe je povezan tudi z novo uvodno izjavo 2a o ponovni predelavi.
This amendment is also linked with the new recital 2a on reprocessing.
ČLEN 2, TOČKA 1 (A) (II A) (novo) Člen 1, odstavek 2, točka (l) (novo) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (A) (II A) (new) Article 1, paragraph 2, point (l) (new) (Directive 93/42/EEC)
(ii a) Doda se naslednja točka (l):
(ii a) The following point (l) is added:
"(l) "biofizični in biomehanski podatki": podatki, ki izhajajo iz biofizičnih, biomehanskih in simulacijskih del, iz modelov, ki so rezultat kliničnih poskusov, ali iz vseh znanstvenih del, ki temeljijo na dokazanih znanjih ali na tehnologijah, katerih ustreznost je dokazana.
"(l) 'biophysical and biomechanical data' means data deriving from biophysical, biomechanical, simulation or clinical test modelling studies or any scientific studies based on confirmed knowledge or technologies whose validity has been demonstrated.
Te podatke se lahko vključi zlasti v podporo kliničnim podatkom iz zgornje točke (k)."
These data may be included, in particular to back up the clinical data mentioned in point (k)."
Za nekatere kategorije medicinskih pripomočkov sta izoblikovanje protokolov in izpeljava kliničnih študij zelo težavna, če že ne nemogoča.
Establishing protocols and conducting clinical studies is difficult and sometimes impossible in the case of certain categories of medical device.
Raziskave danes omogočajo, da se pomanjkljivosti omilijo z biofizičnimi in simulacijskimi pripomočki ter s pripomočki za modeliranje.
Research now makes it possible to overcome these difficulties by establishing biophysical, simulation and modelling tools.
Ti poskusi omogočajo preverjanje zanesljivosti v predkliničnih fazah in bolj ciljno naravnane klinične študije.
This means that the preclinical stages can be made more reliable and clinical studies can be better targeted.
ČLEN 2, TOČKA 1 (E) Člen 1, odstavek 4 b (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (E) Article 1, paragraph 4b (Directive 93/42/EEC)
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za izdelek iz človeških tkiv v smislu [člena 2(2) Uredbe (ES) št. […] Evropskega parlamenta in Sveta(**) [o naprednih terapijah in spremembi Uredbe (ES) št 726/2004]] in ki ima verjetno ob tem medicinskem pripomočku na telo dopolnilni učinek , se mora ta pripomoček oceniti in odobriti v skladu s to direktivo .
Where a device incorporates, as an integral part, a substance, which, if used separately, may be considered to be a human tissue engineered product within the meaning of [Article 2 (2) of R egulation (EC) No […] of the European Parliament and of the Council (**) [on advanced Therapies and amending Regulation (EC) No 726/2004]] and which is liable to act upon the body with action that is ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive.
ČLEN 2, TOČKA 1 (F) (I) Člen 1, odstavek 5, točka (c) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (F) (I) Article 1, paragraph 5, point (c) (Directive 93/42/EEC)
(c) zdravila, ki jih ureja Direktiva 2001/83/ES.
(c) medicinal products covered by Directive 2001/83/EC.
Pri odločanju, ali izdelek ureja navedena direktiva ali ta direktiva, je treba upoštevati zlasti glavno namensko uporabo zadevnega izdelka.
In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal mode of action of the product;
Pri odločanju, ali izdelek ureja navedena direktiva ob uporabi meril iz pododstavka (b) člena 1(2) navedene direktive ali ta direktiva, je treba upoštevati zlasti glavno namensko uporabo zadevnega izdelka
In deciding whether a product falls under that Directive by virtue of the application of the criteria laid down in Article 1(2)(b) of that Directive or under the present Directive, particular account shall be taken of the principal mode of action of the product;
Natančnejša opredelitev v direktivi o ,pripomočkih‘ bo preprečila opisovanje ali potrjevanje zdravil kot medicinskih pripomočkov, z namenom da bi se izognili strogim postopkom odobritev in varnostnim ukrepom, povezanim z zdravili.
Making the definition in the 'devices' directive stricter will ensure that medicinal products are not described and certified as medical devices, with the aim of evading the strict approval procedures and safety precautions relating to medicinal products.
Direktiva o medicinskih pripomočkih se ne uporablja, kadar je izdelek skladen z opredelitvijo ‚zdravila‘ iz direktive o zdravilih.
The medical devices directive does not apply if the product complies with the definition of 'medicinal product' in the medicinal products directive.
Da bi opredelili, ali je izdelek zdravilo ali medicinski pripomoček, je torej potrebno v skladu z Direktivo 2001/83 upoštevati vsako navedeno merilo za zdravilo posamezno, namesto vseh skupaj.
For the purpose of determining whether a product is a medicinal product or a medical device, therefore, it is therefore important to consider, in accordance with Directive 2001/83, all the separate criteria stated for a medicinal product, as alternatives rather than cumulatively.
ČLEN 2, TOČKA 1 (F) (I A) (novo)
ARTICLE 2, POINT 1 (F) (I A) (new)
Člen 1, odstavek 5, točka (d) (Direktiva 93/42/EGS)
Article 1, paragraph 5, point (d) (Directive 93/42/EEC)
(ia) točka (d) se nadomesti z:
(ia) point (d) is replaced by the following:
"(d) kozmetični izdelki, ki jih ureja Direktiva 76/768/EGS.
"(d) cosmetic products covered by Directive 76/768/EEC.
Pri odločanju, ali izdelek ureja Direktiva 76/768/EC ali sedanja direktiva, je treba upoštevati zlasti glavni predvideni namen in mehanizem delovanja izdelka.“
In deciding whether a product falls under Directive 76/768/EEC or this Directive, particular account shall be taken of the principal intended purpose of the product and the relevant mechanism of action;"
V nekaterih primerih imajo kozmetični izdelki medicinski namen (npr. zdravljenje bolezni) in bi jih bilo zato treba uvrstiti med medicinske pripomočke.
In some cases cosmetic products have a medical intention (i.e. treatment of a disease) and should therefore be classified as medical devices.
Zato bi bilo treba odločitev o tem, katera direktiva se uporablja, sprejeti za vsak primer posebej na podlagi predvidenega namena.
The decision which directive applies should thus be taken case by case on the basis of the intended purpose.
ČLEN 2, TOČKA 1 (G) Člen 1, odstavek 6 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (G) Article 1, paragraph 6 (Directive 93/42/EEC)
(g) Odstavek 6 se črta .
(g) Paragraph 6 is deleted.
(g) Odstavek 6 se nadomesti z:
(g) Paragraph 6 is replaced by the following:
Če se namerava izdelek uporabiti v skladu z Direktivo Sveta 89/686/EGS z dne 21. decembra 1989 o približevanju zakonodaj držav članic v zvezi z osebno zaščitno opremo 1 in to direktivo, morajo biti izpolnjene tudi ustrezne osnovne zahteve za zdravje in varnost iz Direktive 89/686/EGS.
Where a product is intended to be used in accordance with Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment 1 and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.
1 UL L 399, 30.12.1989, str.
1 OJ L 399, 30.12.1989, p.
Direktiva, kakor je bila nazadnje spremenjena z Uredbo 1882/2003/ES Evropskega parlamenta in Sveta (UL L 284, 31.10.2003, str.
Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p.
Obstaja nekaj izdelkov za osebno zaščito, ki spadajo na področje uporabe Direktive 93/42/EGS.
There are some personal protection items which fall within the scope of Directive 93/42/EEC.
To velja zlasti za izdelke, ki so v neposrednem stiku z notranjimi deli telesa, npr. rokavice.
This applies in particular to items which come into direct contact with internal parts of the body, such as gloves.
ČLEN 2, ODSTAVEK 1 A (novo)
ARTICLE 2, POINT 1 A (new)
Člen 2, odstavek 1 a (novo) (Direktiva 93/42/EGS)
Article 2, paragraph 1 a (new) (Directive 93/42/EEC)
(1a) V členu 2 se doda odstavek:
(1a) In Article 2, the following paragraph is added:
Države članice prav tako sprejmejo vse potrebne ukrepe za zagotovitev, da prodaja medicinskih pripomočkov prek interneta, po pošti in prek drugih distribucijskih kanalov ne ogroža zdravja in varnosti potrošnikov ter da je v skladu z vsemi določbami iz te direktive.“
"Member States shall also take all necessary steps to ensure that sales of medical devices via the Internet, by mail order and other alternative distribution channels do not put the health and safety of consumers at risk, and that such sales comply with all the provisions of this Directive."
Upoštevati je treba zlasti prodajo medicinskih pripomočkov prek interneta.
The sale of medical devices on the internet in particular should be subject to monitoring.
Preprečiti je treba, da takšni in drugačni načini trženja ne ogrožajo zdravja potrošnikov.
Care must be taken to ensure that this and other sales channels do not endanger consumers' health.
ČLEN 2, TOČKA 2 Člen 4, odstavek 2, alinea 2 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 2 Article 4, paragraph 2, indent 2 (Directive 93/42/EEC)
– dajanja na trg ali v uporabo uporabniku prilagojenih pripomočkov, če izpolnjujejo pogoje iz člena 11 v kombinaciji s Prilogo VIII; pripomočke v razredih IIa, IIb in III mora spremljati izjava iz Priloge VIII, ki bo posredovana imenovanemu pacientu.
— custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be provided to the named patient.
– dajanja na trg ali v uporabo uporabniku prilagojenih pripomočkov, če izpolnjujejo pogoje iz člena 11 v kombinaciji s Prilogo VIII; pripomočke v razredih IIa, IIb in III mora spremljati izjava iz Priloge VIII, ki bo posredovana imenovanemu pacientu ali pacientu, identificiranemu z akronimom ali numerično kodo .
— custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be provided to the named patient or the patient identified by an acronym or a numerical code .
Obstoheča direktiva že navaja izraz "imenovani pacient".
The term 'named patient' is already contained in the current Directive.
Zaradi varovanja podatkov in zdravniške zaupnosti je treba omogočiti tudi identifikacijo pacienta z akronimom ali numerično kodo.
It might also be possible, for the purposes of data protection and medical confidentiality, to provide for identification of the patient through an acronym or numerical code.
Za čim boljšo obveščenost pacienta mora biti originalna izjava še naprej shranjena v pacientovi kartoteki pri zobozdravniku, pacient pa dobi kopijo.
With a view to the best possible provision of information to the patient, the original statement should continue to be kept in the patient's records held by the dentist and a copy supplied to the patient.
Glede na to, da pacient ni dolžan hraniti izjave, je to praktična in primerna ureditev, ki ne ogroža pacientovih pravic.
Given that there is no obligation on the patient to keep the statement, this is a practical and appropriate arrangement which does not undermine the patient's rights.
ČLEN 2, TOČKA 2 A (novo) Člen 7 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 2 A (new) Article 7 (Directive 93/42/EEC)
(2a) Člen 7 se spremeni:
(2a) Article 7 is amended as follows:
(a) prvi pododstavek odstavka 2 se nadomesti z naslednjim:
(a) The first subparagraph of paragraph 2 is replaced by the following:
"Pri sklicevanju na ta odstavek se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določb iz člena 8 tega sklepa."
"Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof."
(b) Vstavi se odstavek 2a:
(b) The following paragraph 2a is inserted:
"Pri sklicevanju na ta odstavek se uporabljata člena 5a in 7 Sklepa 1999/468/ES."
"Where reference is made to this paragraph, Articles 5a and 7 of Decision 1999/468/EC shall apply."
Predlog spremembe je potreben, da bi besedilo uskladili z določbami iz novega "komitološkega" sklepa in zlasti da bi vključili postopek "regulativnega odbora z nadzorom", ker so nekateri zadevni ukrepi splošnega obsega, namenjeni spreminjanju nebistvenih elementov osnutka zakonodaje.
The amendment is needed to align the text to the provisions of the new "commitology" Decision, and in particular to include the "regulatory committee with scrutiny", since some the measures concerned are measures of general scope designed to amend non-essential elements of the draft legislation.
ČLEN 2, TOČKA 2 B (novo) Člen 8, odstavek 2, alinea 2 a (novo) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 2 B (new) Article 8, paragraph 2, indent 2a (new) (Directive 93/42/EEC)
(2b) V člen 8(2) se doda alinea:
(2b) In Article 8(2), the following indent is added:
"- so ukrepi upravičeni, sprejme, ko je to potrebno v interesu javnega zdravja, ustrezne ukrepe Skupnosti v skladu s postopkom iz člena 7(2a)."
"- the measures are justified, it shall adopt, when necessary in the interests of public health, the appropriate Community measures in accordance with the procedure laid down in Article 7(2a)."
Sklicevanje na zaščitno klavzulo bi moralo omogočati, da upravičeni začasni nacionalni ukrepi (v tem okviru) obvezno veljajo na celotnem trgu EU.
Invoking the safeguard clause should allow to have the justified national interim measures (taken in this context) mandatory applicable throughout the EU market.
Poleg tega je postopek zaščitne klavzule iz člena 8 direktive o medicinskih pripomočkih smiselno uskladiti s postopkom posebnih ukrepov za spremljanje zdravja iz člena 14b direktive o medicinskih pripomočkih.
In addition it is useful to align the safeguard clause procedure in Article 8 MDD with the particular health monitoring measures procedure in Article 14b MDD.
ČLEN 2, TOČKA 3 Člen 9, odstavek 3 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 3 Article 9, paragraph 3 (Directive 93/42/EEC)
Če država članica meni, da je treba klasifikacijska pravila iz Priloge IX prilagoditi glede na tehnični napredek in vse informacije, dostopne v okviru informacijskega sistema iz člena 10, predloži Komisiji ustrezno utemeljeno prošnjo in jo zaprosi za ustrezne ukrepe.
Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Komisija sprejme te ukrepe v skladu s postopkom iz člena 7(2) .
The Commission shall adopt these measures in accordance with the procedure referred to in Article 7 (2).
Komisija sprejme te ukrepe v skladu s postopkom iz člena 7(2a) .
The Commission shall adopt these measures in accordance with the procedure referred to in Article 7(2a).
ČLEN 2, TOČKA 3 A (novo) Člen 10, odstavek 3 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 3 A (new) Article 10, paragraph 3 (Directive 93/42/EEC)
(3a) Člen 10(3) se nadomesti z:
(3a) In Article 10(3) is replaced by the following:
"Po izpeljani oceni, po možnosti skupaj s proizvajalcem, države članice brez poseganja v določbe člena 8 nemudoma obvestijo Komisijo in druge države članice o zapletih iz odstavka 1, za katere so bili uvedeni ali načrtovani ustrezni ukrepi.
After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which relevant measures are contemplated or have been taken.
Države članice navedejo točne razloge za preučitev načrtovanih ukrepov ali za sprejete ukrepe.
The Member States shall state the exact grounds underlying the measures that are contemplated or that have been taken.
Države članice zlasti navedejo točne razloge, če je to primerno, za odklon od načrtovanih ukrepov v sprejetih ukrepih.
In particular, the Member States shall give the exact grounds, when appropriate, for deviating from the contemplated measure in the measure taken."
Ker je postopek nadzora povezan z obveščanjem o zapletih, je izredno pomembno, da ga usklajuje Komisija ter da imajo Komisija in države članice popoln pregled nad trgom EU.
As the vigilance procedure relates to the notification of incidents it is of utmost importance that this is coordinated through the Commission and that the Commission and the Member States to have a complete overview of the EU market.
ČLEN 2, TOČKA 3 B (novo) Člen 10, odstavek 4 (novo) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 3 B (new) Article 10, paragraph 4 (new) (Directive 93/42/EEC)
(3b) V členu 10 se doda odstavek:
(3b) In Article 10, the following paragraph is added:
Komisija v skladu s postopkom iz člena 7(2) sprejme vse ustrezne ukrepe za sprejetje postopkov za izvajanje tega člena."
The Commission, acting in accordance with the procedure referred to in Article 7(2), shall take any appropriate measures to adopt procedures to implement this Article."
Predlog spremembe, ki zagotavlja, da sistem nadzora deluje bolj zavezujoče.
Amendment ensuring that the vigilance system functions in more binding detail.
ČLEN 2, TOČKA 4 (B) Člen 11, odstavek 14 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 4 (B) Article 11, paragraph 14 (Directive 93/42/EEC)
(b) Doda se naslednji odstavek:
(b) The following paragraph is added:
Komisija lahko, v skladu s postopkom iz člena 7(2), sprejme ukrepe, s katerimi se navodila za uporabo zagotovijo z drugimi sredstvi.“
The Commission may, in accordance with the procedure referred to in Article 7 (2), adopt measures allowing instructions for use to be provided by other means."
Ta člen je bil vključen v poročilo brez glasovanja na podlagi člena 47 Poslovnika.
This amendment was incorporated in the report without vote on the basis of Rule 47 of Rules of Procedure.
Omogočiti je treba, da strokovnjaki informacije o varni in pravilni uporabi medicinskih pripomočkov posredujejo prek sodobnih sredstev komuniciranja (npr. elektronskega označevanja).
There should be the possibility of providing information for the safe and correct use of medical devices by professionals through modern means of communication (e.g. e-labelling).
ČLEN 2, TOČKA 5 (-A) (novo) Člen 12, odstavek 2, pododstavek 2 a (novo) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 5 (-A) (new) Article 12, paragraph 2, subparagraph 2 a (new) (Directive 93/42/EEC)
(-a) V odstavku 2 se doda pododstavek:
(-a) In paragraph 2, the following subparagraph is added:
"V primeru omrežnih zdravstvenih IT sistemov se ta člen ne uporablja za celoten omrežni sistem.
"In the case of networked medical information technology systems, this Article shall not apply for the overall network system.
Ugotavljanje skladnosti je treba izvesti za vsak medicinski pripomoček v omrežju posebej in ne za celoten omrežni sistem."
The conformity assessment must be performed separately for each medical device in the network, and not for the overall network system."
Izmenjava posameznih delov velikega IT omrežja mora biti možna npr. brez ponovnega potrjevanja celotnega omrežja.
It must be possible to exchange individual parts of a large IT network, for example, without having to recertify the entire network.
Posamezne sestavne dele takšnih sistemov je zato treba potrditi ločeno.
The individual components of such systems must therefore be certified separately.
ČLEN 2, TOČKA 5 (A)
ARTICLE 2, POINT 5 (A)
Člen 12, odstavek 3 (Direktiva 93/42/EGS)
Article 12, paragraph 3 (Directive 93/42/EEC)
(a) V odstavku 3 se besede „Prilog IV, V in VI“ nadomestijo s „Prilog II, IV, V in VI“.
(a) In paragraph 3, the words “Annex IV, V or VI” are replaced by “Annex II, IV, V or VI”.
(a) V odstavku 3 se besede „Priloga IV, V ali VI“ nadomestijo s „Priloga II, IV, V ali VI“ in besede "postopka za doseganje sterilnosti" s "postopka za doseganje in vzdrževanje sterilnosti v trajanju roka uporabnosti pripomočka ali do odprtja oziroma poškodbe sterilne ovojnine ".
(a) In paragraph 3, the words “Annex IV, V or VI” are replaced by “Annex II, IV, V or VI” and the words "the obtaining of sterility" are replaced by "the obtaining and maintaining of sterility for the shelf life of the device or until the sterile package is opened or damaged" .
ČLEN 2, TOČKA 6 Člen 13, odstavek 1 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 6 Article 13, paragraph 1 (Directive 93/42/EEC)
(6) V členu 13(1) se doda točka (d) :
(6) In Article 13(1) the following point (d) is inserted:
(d) uveljavljanje klasifikacijskih pravil iz Priloge IX zahteva odločitev, ali je izdelek opredeljen v členu 1(2)(a) do (e) ;“
(d) application of the classification rules set out in Annex IX requires a decision as to whether a product falls within one of the definitions in Article 1 paragraph 2, points (a) to (e) ,”;
(6) Člen 13(1) se nadomesti z:
(6) Article 13(1) is replaced by the following:
Če država članica meni, da:
Where a Member State considers that: