natgillin/translations-raw huggingface dataset:
Annex IX shall be amended as follows:
Priloga IX se spremeni:
Chapter I shall be amended as follows:
poglavje I se spremeni:
in Section 1.4, the following sentence shall be added:
v oddelku 1.4 se doda stavek:
‘Stand alone software is considered to be an active medical device.’;
„Samostojna programska oprema se obravnava kot aktivni medicinski pripomoček.“;
Section 1.7 shall be replaced by the following:
oddelek 1.7 se nadomesti z:
Central circulatory system
Osrednji žilni sistem
For the purposes of this Directive, “central circulatory system” means the following vessels:
V tej direktivi ‚osrednji žilni sistem‘ pomeni naslednja obtočila:
arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;
arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens v bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.“;
in Chapter II, Section 2, the following section shall be added:
v oddelku 2 poglavja II se doda naslednji oddelek:
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”.
Pri izračunu trajanja iz oddelka 1.1 poglavja I pomeni neprekinjena uporaba neprekinjeno dejansko uporabo pripomočka za predvideni namen.
However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;
Vseeno se to, če je uporaba pripomočka prekinjena, zato da se pripomoček takoj zamenja z istim ali identičnim pripomočkom, obravnava kot podaljšanje neprekinjene uporabe pripomočka.“;
Chapter III shall be amended as follows:
poglavje III se spremeni:
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:
uvodno besedilo prvega odstavka oddelka 2.1 se nadomesti z:
‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;
„Vsi invazivni pripomočki, ki se uporabljajo prek telesnih odprtin ter ki niso kirurško invazivni pripomočki in ki niso namenjeni priključevanju na aktivne medicinske pripomočke ali ki so namenjeni priključevanju na aktivne medicinske pripomočke v razredu I:“;
Rule 6
Pravilo 6
All surgically invasive devices intended for transient use are in Class IIa unless they are:
Vsi kirurško invazivni pripomočki, namenjeni prehodni uporabi, spadajo v razred IIa, razen če so:
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
izrecno namenjeni nadziranju, diagnosticiranju, spremljanju ali popravljanju okvar srca ali osrednjega žilnega sistema prek neposrednega stika s temi telesnimi deli; v tem primeru spadajo v razred III,
reusable surgical instruments, in which case they are in Class I,
kirurški instrumenti za ponovno uporabo; v tem primeru spadajo v razred I,
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
izrecno namenjeni uporabi v neposrednem stiku z osrednjim živčnim sistemom; v tem primeru spadajo v razred III,
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
namenjeni za dovajanje energije v obliki ionizirajočega sevanja; v tem primeru spadajo v razred IIb,
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
namenjeni doseganju biološkega učinka ali za absorbiranje v celoti ali pretežno; v tem primeru spadajo v razred IIb,
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
namenjeni dajanju zdravil s pomočjo sistema za doziranje, če se to izvaja na način, ki je potencialno nevaren ob upoštevanju načina dajanja; v tem primeru spadajo v razred IIb.“;
in Section 2.3, the first indent shall be replaced by the following:
v oddelku 2.3 se prva alinea nadomesti z:
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
izrecno nadziranju, diagnosticiranju, spremljanju ali popravljanju okvar srca ali osrednjega žilnega sistema prek neposrednega stika s temi telesnimi deli; v tem primeru spadajo v razred III,“;
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
v prvem odstavku oddelka 4.1 se sklicevanje na „65/65/EGS“ nadomesti s sklicevanjem na „2001/83/ES“;
in Section 4.1, the second paragraph shall be replaced by the following:
v oddelku 4.1 se drugi odstavek nadomesti z:
‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;
„Vsi pripomočki, ki kot svoj sestavni del vsebujejo derivat človeške krvi, spadajo v razred III.“;
in Section 4.3, second paragraph, the following phrase shall be added:
v drugi odstavek oddelka 4.3 se doda besedilo:
‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;
„razen če so izrecno namenjeni uporabi pri razkuževanju invazivnih pripomočkov; v tem primeru spadajo v razred IIb.“;
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;
v oddelku 4.4 se besedi „Neaktivni pripomočki“ nadomestita z besedo „Pripomočki“;
Annex X shall be amended as follows:
Priloga X se spremeni:
Section 1.1 shall be replaced by the following:
oddelek 1.1 se nadomesti z:
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 side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data.
Po splošnem pravilu morajo potrditev skladnosti z zahtevami v zvezi z lastnostmi in delovanjem iz oddelkov 1 in 3 Priloge I v normalnih pogojih uporabe pripomočka, ter ovrednotenje stranskih učinkov in sprejemljivosti razmerja med koristmi in tveganjem iz oddelka 6 Priloge I temeljiti na kliničnih podatkih.
The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:
Vrednotenje teh podatkov, v nadaljevanju klinično vrednotenje, pri katerem se ustrezno upošteva vsak ustrezno usklajen standard, mora upoštevati opredeljen in metodološko dober postopek, ki temelji na:
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:
kritičnem vrednotenju ustrezne sodobne znanstvene literature, ki je zdaj na voljo v zvezi z varnostjo, delovanjem, značilnostmi načrta in predvidenim namenom pripomočka, če:
there is demonstration of equivalence of the device to the device to which the data relates, and
obstaja dokazilo o enakovrednosti pripomočka s pripomočkom, za katerega veljajo podatki, in
the data adequately demonstrate compliance with the relevant essential requirements.
podatki ustrezno dokazujejo skladnost z ustreznimi bistvenimi zahtevami;
Or a critical evaluation of the results of all clinical investigations made.
ali kritičnem vrednotenju rezultatov vseh opravljenih kliničnih preiskav;
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’
ali kritičnem vrednotenju združenih kliničnih podatkov iz 1.1.1 in 1.1.2.“;
The following Sections shall be inserted:
vstavijo se naslednji oddelki:
‘1.1a
„1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.
V primeru pripomočkov za vsaditev in pripomočkov v razredu III se opravijo klinične preiskave, razen če se ustrezno utemelji, da temeljijo na obstoječih kliničnih podatkih.
Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;
Ustreznost dokazovanja skladnosti z bistvenimi zahtevami z vrednotenjem delovanja, laboratorijskimi preskusi in predkliničnim vrednotenjem je treba ustrezno utemeljiti.“;
in Section 2.2, the first sentence shall be replaced by the following:
v oddelku 2.2 se prvi stavek nadomesti z: „Klinične preiskave morajo biti opravljene v skladu s helsinško deklaracijo, sprejeto na 18.
‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;
Svetovni medicinski skupščini v Helsinkih na Finskem leta 1964, kakor je bila nazadnje spremenjena na Svetovni medicinski skupščini.“;
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.
Vsi resni neželeni učinki morajo biti v celoti zabeleženi in takoj posredovani vsem pristojnim organom držav članic, kjer potekajo klinične preiskave.“
Regulation as last amended by Regulation (EC) No 1901/2006.’
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1901/2006.“;
OJ 196, 16.8.1967, p. 1.
UL L 196, 16.8.1967, str. 1.
Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2006/121/ES Evropskega parlamenta in Sveta (UL L 396, 30.12.2006, str. 850).“;
Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’
Direktiva Komisije 2003/32/ES z dne 23. aprila 2003 o uvedbi podrobnih tehničnih zahtev v zvezi z zahtevami, določenimi v Direktivi Sveta 93/42/EGS o medicinskih pripomočkih, izdelanih z uporabo tkiv živalskega izvora (UL L 105, 26.4.2003, str. 18).“;
The Commission shall inform all the Member States and the consulted interested Parties thereof.
Komisija o tem obvesti vse države članice in zainteresirane strani, s katerimi se je posvetovala.
When appropriate, the necessary measures designed to amend non-essential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Po potrebi se v skladu z regulativnim postopkom s pregledom iz člena 7(3) sprejmejo ustrezni ukrepi za spreminjanje nebistvenih določb te direktive v zvezi z umikom določenih izdelkov ali skupin izdelkov s trga, prepovedjo njihovega dajanja na trg in dajanja v uporabo ali omejevanjem oziroma uvedbo posebnih zahtev za začetek njihovega dajanja na trg.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4).’;
Zaradi nujnih razlogov lahko Komisija uporabi nujni postopek iz člena 7(4).“;
In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;
Proizvajalec ali njegov pooblaščeni zastopnik morata hraniti to dokumentacijo, skupaj z izjavo o skladnosti, na voljo nacionalnim organom za namene inšpekcije za obdobje najmanj petih let od izdelave zadnjega izdelka, v primeru pripomočkov za vsaditev pa za najmanj 15 let po proizvodnji zadnjega pripomočka.“;
In the case of implantable devices the period shall be at least 15 years.’;
Informacije iz izjav, ki jih ureja ta priloga, se hranijo najmanj pet let, v primeru pripomočkov za vsaditev pa za najmanj 15 let.“;
The introductory phrase shall be replaced by the following:
uvodni stavek se nadomesti z:
‘This Directive shall not apply to:’;
„Ta direktiva se ne uporablja za:“;
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured.
Proizvajalec mora pripraviti tehnično dokumentacijo, opisano v oddelku 3.
Section 4 shall be replaced by the following: ‘4.
oddelek 4 se nadomesti z:
Commission Directive 2007/48/EC
Direktiva Komisije 2007/48/ES
amending Directive 2003/90/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species
o spremembi Direktive 2003/90/ES o določitvi izvedbenih ukrepov za namene člena 7 Direktive Sveta 2002/55/ES glede lastnosti, ki morajo biti zajete kot minimum pri preskušanju, in minimalnih pogojev za preskušanje nekaterih sort zelenjadnic
Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species [1], and in particular Article 7(2)(a) and (b) thereof,
ob upoštevanju Direktive Sveta 2002/53/ES z dne 13. junija 2002 o skupnem katalogu sort poljščin [1] in zlasti člena 7(2)(a) in (b) Direktive,
Commission Directive 2003/90/EC [2] was adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining the varieties, as far as such guidelines had been established.
Direktiva Komisije 2003/90/ES [2] je bila sprejeta za zagotovitev, da sorte iz nacionalnih katalogov držav članic izpolnjujejo smernice, ki jih je določil Urad skupnosti za rastlinske sorte (USRS) glede lastnosti, ki morajo biti zajete kot minimum pri preskušanju, in minimalnih pogojev za preskušanje sort, če so bile takšne smernice oblikovane.
For other varieties that Directive provides that the guidelines of the International Union for the Protection of new Varieties of Plants (UPOV) are to apply.
Za druge sorte Direktiva določa uporabo smernic Mednarodne konvencije za varstvo novih rastlinskih sort (UPOV).
The CPVO and UPOV have since established further guidelines for a number of other species or have updated existing ones.
USRS in UPOV sta od takrat določila nadaljnje smernice za več drugih vrst ali posodobila že obstoječe.
Directive 2003/90/EC should therefore be amended accordingly.
Direktivo 2003/90/ES bi bilo zato treba ustrezno spremeniti.
Annexes I and II to Directive 2003/90/EC are replaced by the text in the Annex to this Directive.
Prilogi I in II k Direktivi 2003/90/ES se nadomestita z besedilom iz Priloge k tej direktivi.
For examinations started before 1 November 2007 Member States may apply Directive 2003/90/EC in the version applying before its amendment by this Directive.
Za preskušanja, ki se začnejo pred 1. novembrom 2007, države članice lahko uporabljajo Direktivo 2003/90/ES v različici, ki se je uporabljala, preden je bila spremenjena s to direktivo.
Directive as amended by Directive 2005/91/EC (OJ L 331, 17.12.2005, p. 24).
Direktiva, kakor je bila spremenjena z Direktivo 2005/91/ES (UL L 331, 17.12.2005, str. 24).
List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols
Seznam vrst iz člena 1(2)(a), ki morajo biti skladne s protokoli za preskušanje USRS
Triticale, TP 121/2 of 22.1.2007
Tritikala, TP 121/2 z dne 22.1.2007
Durum wheat, TP 120/2 of 6.11.2003
Trda pšenica, TP 120/2 z dne 6.11.2003
Potato, TP 23/2 of 1.12.2005
Krompir, TP 23/2 z dne 1.12.2005
Flax/Linseed
Lan/Laneno seme
Flax/Linseed, TP 57/1 of 21.3.2007
Lan/Laneno seme, TP 57/1 z dne 21.3.2007
List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines
Seznam vrst iz člena 1(2)(b), ki morajo biti skladne s smernicami za preskušanje USRS
Cocksfoot
Pasja trava
Cocksfoot, guideline TG/31/8 of 17.4.2002
Pasja trava, smernica TG/31/8 z dne 17.4.2002
Sheep's fescue, guideline TG/67/5 of 5.4.2006
Ovčja bilnica, smernica TG/67/5 z dne 5.4.2006
Red fescue, guideline TG/67/5 of 5.4.2006
Rdeča bilnica, smernica TG/67/5 z dne 5.4.2006
Ryegrass, guideline TG/4/8 of 5.4.2006
Ljuljka, smernica TG/4/8 z dne 5.4.2006
Timothy
Mačji rep
Timothy, guideline TG/34/6 of 7.11.1984
Mačji rep, smernica TG/34/6 z dne 7.11.1984
Swede, guideline TG 89/6 of 4.4.2001
Podzemna koleraba, smernica TG/89/6 z dne 4.4.2001
Soya bean, guideline TG/80/6 of 1.4.1998
Soja, smernica TG/80/6 z dne 1.4.1998
Commission Directive 2007/49/EC
Direktiva Komisije 2007/49/ES
amending Directive 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/55/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of vegetable species
o spremembi Direktive 2003/91/ES o določitvi izvedbenih ukrepov za člen 7 Direktive Sveta 2002/55/ES glede lastnosti, ki morajo biti zajete kot minimum pri preskušanju, in minimalnih pogojev za preskušanje nekaterih sort zelenjadnic
Commission Directive 2003/91/EC [2] was adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining the varieties, as far as such guidelines had been established.
Direktiva Komisije 2003/91/ES [2] je bila sprejeta za zagotovitev, da sorte iz nacionalnih sortnih list držav članic izpolnjujejo smernice, ki jih je določil Urad skupnosti za rastlinske sorte (USRS) glede lastnosti, ki morajo biti zajete kot minimum pri preskušanju, in minimalnih pogojev za preskušanje sort, če so bile takšne smernice oblikovane.
The CPVO and UPOV have since issued further guidelines for a number of other species, or have updated existing ones.
USRS in UPOV sta od takrat izdala nadaljnje smernice za več drugih vrst ali posodobila že obstoječe.
Directive 2003/91/EC should therefore be amended accordingly.
Direktivo 2003/91/ES je zato treba ustrezno spremeniti.
Annexes I and II to Directive 2003/91/EC are replaced by the text in the Annex to this Directive.
Prilogi I in II k Direktivi 2003/91/ES se nadomestita z besedilom iz Priloge k tej direktivi.
For examinations started before 1 November 2007, Member States may apply Directive 2003/91/EC in the version applying before its amendment by this Directive.
Za preskušanja, ki se začnejo pred 1. novembrom 2007, države članice lahko uporabljajo Direktivo 2003/91/ES v različici, ki se je uporabljala, preden je bila spremenjena s to direktivo.
Member States shall adopt and publish, by 31 October 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 31. oktobra 2007 sprejmejo in objavijo zakone, uredbe in upravne predpise, potrebne za uskladitev s to direktivo.
Directive as amended by Directive 2006/127/EC (OJ L 343, 8.12.2006, p. 82).
Direktiva, kakor je bila spremenjena z Direktivo 2006/127/ES (UL L 343, 8.12.2006, str. 82).
Allium cepa L. (Cepa group)
Allium cepa L. (skupina čebul)
TP 151/2 of 21.3.2007
TP 151/2 z dne 21.3.2007
Chilli or Pepper
Čili ali poper
TP 76/2 of 21.3.2007
TP 76/2 z dne 21.3.2007
TP 142/1 of 21.3.2007
TP 142/1 z dne 21.3.2007
TP 104/2 of 21.3.2007
TP 104/2 z dne 21.3.2007
TP 13/3 of 21.3.2007
TP 13/3 z dne 21.3.2007
TP 44/3 of 21.3.2007
TP 44/3 z dne 21.3.2007
TP 136/1 of 21.3.2007
TP 136/1 z dne 21.3.2007
Runner bean
Turški (laški) fižol
TP 9/1 of 21.3.2007
TP 9/1 z dne 21.3.2007
Dwarf French bean and Climbing French bean
Navadni fižol in visoki fižol
TP 7/1 of 6.11.2003
TP 7/1 z dne 6.11.2003
Radish
Redkev
TP 75/2 of 21.3.2007
TP 75/2 z dne 21.3.2007
Sweet corn and Popcorn
Sladka koruza in pokovka
TG/74/4 corr. of 17.4.2002 + 5.4.2006
TG/74/4 popravek z dne 17.4.2002 in 5.4.2006
Beetroot including Cheltenham beet
Rdeča pesa, vključno z cheltenhamsko peso
Turnip
Repa
TG/155/4 of 14.3.2007
TG/155/4 z dne 14.3.2007
Scorzonera or Black salsify
Črni koren (navadni gadnjak)
List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines
Seznam vrst iz člena 1(2)(b), ki morajo biti skladne s smernicami za preskušanje UPOV
Commission Directive 2007/50/EC
Direktiva Komisije 2007/50/ES
amending Council Directive 91/414/EEC to include beflubutamid and Spodoptera exigua nuclear polyhedrosis virus as active substances
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve beflubutamida in virusa jedrne poliedričnosti Spodoptera exigua kot aktivne snovi
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [1], and in particular Article 6(1) thereof,
ob upoštevanju Direktive Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [1] in zlasti člena 6(1) te direktive,
In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 27 June 2000 an application from a Task Force consisting of UBE Europe GmbH and Stähler Agrochemie GmbH & Co. KG (UBE Europe GmbH having later left the Task Force) for the inclusion of the active substance beflubutamid in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Nemčija 27. junija 2000 prejela prošnjo projektne skupine, ki sta jo sestavljala UBE Europe GmbH in Stähler Agrochemie GmbH & Co. KG (UBE Europe GmbH je projektno skupino pozneje zapustil), za vključitev aktivne snovi beflubutamid v Prilogo I k Direktivi 91/414/EGS.
Commission Decision 2000/784/EC [2] confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Komisija je z Odločbo 2000/784/ES [2] potrdila, da je dokumentacija popolna v smislu načelnega izpolnjevanja zahtev po podatkih in informacijah iz prilog II in III k Direktivi 91/414/EGS.
In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 12 July 1996 an application from Biosys (now: Certis USA) for the inclusion of the active substance Spodoptera exigua nuclear polyhedrosis virus (hereinafter Spodoptera exigua NPV) in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Nizozemska 12. julija 1996 prejela prošnjo družbe Biosys (zdaj Certis ZDA) za vključitev aktivne snovi virus jedrne poliedričnosti Spodoptera exigua (v nadaljevanju „VJP Spodoptera exigua“) v Prilogo I k Direktivi 91/414/EGS.
Commission Decision 97/865/EC [3] confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Komisija je z Odločbo 97/865/ES [3] potrdila, da je dokumentacija popolna v smislu načelnega izpolnjevanja zahtev po podatkih in informacijah iz prilog II in III k Direktivi 91/414/EGS.