natgillin/translations-raw huggingface dataset:
Upon reasoned request, the relevant inspection services shall forward a copy of the last inspection report of the manufacturing site or, in case analytical operations are contracted out, of the control site.
Ustrezne inšpekcijske službe na utemeljeno zahtevo posredujejo izvod zadnjega inšpekcijskega poročila o proizvodnem objektu ali, če analitične postopke izvajajo zunanji sodelavci, kontrolnem laboratoriju.
The request may concern a “full inspection report” or a “detailed report” (see item 2 below).
Zahteva se lahko nanaša na ‚celotno inšpekcijsko poročilo‘ ali ‚podrobno poročilo‘ (glej točko 2 spodaj).
Each party shall deal with these inspection reports with the degree of confidentiality requested by the providing Party.
Vsaka pogodbenica ravna s temi inšpekcijskimi poročili s stopnjo zaupnosti, ki jo zahteva pogodbenica, ki poročilo zagotovi.
Parties will ensure that inspection reports are forwarded in no more than thirty calendar days, this period being extended to sixty days should a new inspection be carried out.
Pogodbenici zagotovita, da se inšpekcijska poročila posredujejo v roku največ tridesetih koledarskih dni, ki se lahko podaljša na šestdeset dni, če je treba izvesti nov inšpekcijski pregled.
Inspection reports
Inšpekcijska poročila
A “full inspection report” comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.
‚Popolno inšpekcijsko poročilo‘ vsebuje glavno datoteko (Site Master File), ki jo sestavi proizvajalec ali inšpektorat, in opisno poročilo inšpektorata.
A “detailed report” responds to specific queries about a firm by the other Party.
‚Podrobno poročilo‘ odgovarja na specifična vprašanja o podjetju, ki jih postavi druga pogodbenica.
GMP Reference
Referenčna dobra proizvodna praksa
Manufacturers shall be inspected against the applicable GMP of the exporting party (see section I).
Pri proizvajalcih se opravi inšpekcijski pregled glede veljavne dobre proizvodne prakse pogodbenice izvoznice (glej oddelek I).
With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations shall inspect against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party.
V zvezi z zdravili, ki jih pokriva farmacevtska zakonodaja pogodbenice uvoznice, ne pa tudi izvoznice, pristojna lokalna inšpekcijska služba, ki je pripravljena izvesti pregled ustreznih proizvodnih postopkov, slednje preveri glede na svojo lastno dobro proizvodno prakso ali, če ni specifičnih zahtev dobre proizvodne prakse, glede na veljavno dobro proizvodno prakso pogodbenice uvoznice.
For specific products or classes of products (e.g. investigational medicinal products, starting materials not limited to active pharmaceutical ingredients), equivalence of GMP requirements shall be determined according to a procedure established by the Committee.
Za specifične izdelke ali razrede izdelkov (npr. zdravila v preskušanju, začetne materiale, ki niso omejeni na aktivne farmacevtske sestavine), se enakovrednost zahtev dobre proizvodne prakse ugotavlja v skladu s postopkom, ki ga določi Odbor.
Nature of inspections
Narava inšpekcij
Inspections shall routinely assess the compliance of the manufacturer with GMP.
Inšpekcije rutinsko ocenjujejo skladnost proizvajalca z dobro proizvodno prakso.
These are called general GMP inspections (also regular, periodic, or routine inspections).
Te se imenujejo splošne inšpekcije dobre proizvodne prakse (tudi redne, periodične ali rutinske inšpekcije).
“Product- or process-oriented” inspections (which may be “pre-marketing” inspections as relevant) focus on the manufacture of one or a series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation.
‚V izdelke ali postopke usmerjene‘ inšpekcije (ki so po potrebi lahko ‚inšpekcije pred začetkom trženja‘) se osredotočajo na proizvodnjo enega izdelka ali serij izdelkov ali na postopke in vključujejo oceno validacije in upoštevanja specifičnih procesnih ali nadzornih vidikov, ki so opisani v dovoljenju za trženje.
Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) shall be provided in confidence to the inspectorate.
Po potrebi se inšpektoratu zaupno predložijo ustrezne informacije o izdelku (dokumentacija o kakovosti za vlogo/izdajo dovoljenja).
The regime of inspection/establishment fees is determined by the manufacturer’s location.
Režim pristojbin za inšpekcije in obdelavo se določa na podlagi lokacije proizvajalca.
Inspection/establishment fees shall not be charged to manufacturers located on the territory of the other Party.
Proizvajalcem na ozemlju druge pogodbenice ni treba plačati nobenih inšpekcijskih pristojbin.
Safeguard clause for inspections
Zaščitna klavzula za inšpekcije
Each Party reserves the right to have its own inspection conducted for reasons identified to the other Party.
Vsaka pogodbenica si pridržuje pravico, da iz razlogov, ki jih sporoči drugi pogodbenici, izvaja svoje lastne inšpekcijske preglede.
Such inspections are to be notified in advance to the other Party and shall, in accordance with Article 8 of this Agreement, be carried out jointly by the competent authorities of the two Parties.
O takšnih inšpekcijah je treba drugo pogodbenico obvestiti vnaprej, v skladu s členom 8 tega sporazuma pa jih skupno izvajajo pristojni organi obeh pogodbenic.
Recourse to this safeguard clause should be an exception.
Ta zaščitna klavzula se uporablja le izjemoma.
Exchange of information between authorities and approximation of quality requirements
Izmenjava informacij med organi in približevanje zahtev glede kakovosti
In accordance with the general provisions of this Agreement, the parties shall exchange any information necessary for the mutual recognition of inspections.
V skladu s splošnimi določbami tega sporazuma si pogodbenici izmenjata vse informacije, ki so potrebne za vzajemno priznavanje inšpekcij.
The relevant authorities in Switzerland and in the Community shall also keep each other informed of any new technical guidance or inspection procedure.
Tudi pristojni organi v Švici in Skupnosti se medsebojno obveščajo o vseh novih strokovnih smernicah ali inšpekcijskih postopkih.
Each party shall consult the other before their adoption and shall endeavour to proceed towards their approximation.
Pogodbenici se pred sprejetjem slednjih vzajemno posvetujeta in si prizadevata za njihovo približevanje.
Inspectors training
Usposabljanje inšpektorjev
In accordance with Article 9 of the Agreement, training sessions for inspectors, organised by the authorities, shall be accessible to inspectors of the other Party.
V skladu s členom 9 Sporazuma je usposabljanje za inšpektorje, ki ga organizirajo pristojni organi, dostopno tudi inšpektorjem druge pogodbenice.
The Parties to the Agreement shall keep each other informed on these sessions.
Pogodbenici se medsebojno obveščata o teh usposabljanjih.
Joint Inspections
Skupne inšpekcije
In accordance with Article 12 of this Agreement, and by mutual agreement between the Parties, joint inspections may be organised.
V skladu s členom 12 tega sporazuma in v vzajemnem dogovoru med pogodbenicama je mogoče organizirati skupne inšpekcije.
These inspections are intended to develop common understanding and interpretation of practice and requirements.
Te inšpekcije so namenjene razvijanju skupnega razumevanja ter razlagi prakse in zahtev.
The setting up of these inspections and their form shall be agreed through procedures approved by the Committee established under Article 10 of this Agreement.
Priprava in oblika teh pregledov se določita s postopki, ki jih odobri Odbor, ustanovljen v skladu s členom 10 tega sporazuma.
Alert system
Sistem opozarjanja
Contact points shall be agreed between both Parties to permit authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch.
Pogodbenici se dogovorita o kontaktnih točkah in tako omogočita organom in proizvajalcem ustrezno hitro obveščanje organov druge pogodbenice v primeru pomanjkljive kakovosti, razveljavitve serij, ponarejanja in drugih težav v zvezi s kakovostjo, zaradi katerih je lahko potreben dodaten nadzor ali začasni preklic distribucije serije.
A detailed alert procedure shall be agreed.
Sporazumno se pripravi podroben postopek opozarjanja.
The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could have public health implications, are communicated to each other with the appropriate degree of urgency.
Pogodbenici zagotovita, da druga drugo z ustrezno stopnjo nujnosti obvestita o vsakem začasnem preklicu ali umiku (celotnega ali dela) proizvodnega dovoljenja, ki temelji na neskladju z dobro proizvodno prakso in ki bi lahko imel posledice za javno zdravje.
For the purpose of this Agreement, the contact points for any technical question, such as exchanges of inspection reports, inspectors training sessions, technical requirements, are:
Za namene tega sporazuma so kontaktne točke za vsa strokovna vprašanja, kakor je izmenjava inšpekcijskih poročil, usposabljanje inšpektorjev, tehnične zahteve, naslednje:
For the EC
Za ES
The Director of the European Medicines Agency.
Direktor Evropske agencije za zdravila.
For Switzerland
Za Švico
The official GMP inspection services listed in Section II above.
Uradne inšpekcijske službe GMP, naštete v oddelku II zgoraj.
Divergence of views
Razlike v mnenjih
Both Parties shall use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports.
Pogodbenici po svojih najboljših močeh rešujeta vse razlike v mnenjih, ki med drugim zadevajo ustreznost proizvajalcev in sklepe inšpekcijskih poročil.
Unresolved divergences of view will be referred to the Committee as established under Article 10 of this Agreement.
Nerešene razlike v mnenjih naslovita na Odbor, ustanovljen v skladu s členom 10 tega sporazuma.
CONSTRUCTION PRODUCTS
GRADBENI Izdelki
Council Directive 89/106/EEC of 21 December 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to construction products (OJ L 40, 11.2.1989, p. 12).
Direktiva Sveta 89/106/EGS z dne 21. decembra 1988 o približevanju zakonov in drugih predpisov držav članic, ki se nanašajo na gradbene proizvode (UL L 40, 11.2.1989, str. 12).
Implementing measures
Izvedbeni ukrepi:
Commission Decision 94/23/EC of 17 January 1994 on common procedural rules for European technical approval (OJ L 17, 20.1.1994, p. 34).
Sklep Komisije 94/23/ES z dne 17. januarja 1994 o skupnih pravilih postopka za podelitev evropskega tehničnega soglasja (UL L 17, 20.1.1994, str. 34).
Commission Decision 94/611/EC of 9 September 1994 implementing Article 20 of Directive 89/106/EEC on construction products (OJ L 241, 16.9.1994, p. 25).
Odločba Komisije 94/611/ES z dne 9. septembra 1994 o izvajanju člena 20 Direktive 89/106/EGS o gradbenih proizvodih (UL L 241, 16.9.1994, str. 25).
Commission Decision 95/204/EC of 31 May 1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 129, 14.6.1995, p. 23).
Odločba Komisije 95/204/ES z dne 31. maja 1995 o izvajanju člena 20(2) Direktive Sveta 89/106/EGS o gradbenih proizvodih (UL L 129, 14.6.1995, str. 23).
Commission Decision 95/467/EC of 24 October 1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 268, 10.11.1995, p. 29).
Odločba Komisije 95/467/ES z dne 24. oktobra 1995 o izvajanju člena 20(2) Direktive Sveta 89/106/EGS o gradbenih proizvodih (UL L 268, 10.11.1995, str. 29).
Commission Decision 96/577/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fixed firefighting systems (OJ L 254, 8.10.1996, p. 44).
Odločba Komisije 96/577/ES z dne 24. junija 1996 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z vgrajenimi protipožarnimi sistemi (UL L 254, 8.10.1996, str. 44).
Commission Decision 96/578/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards sanitary appliances (OJ L 254, 8.10.1996, p. 49).
Odločba Komisije 96/578/ES z dne 24. junija 1996 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s sanitarnimi napravami (UL L 254, 8.10.1996, str. 49).
Commission Decision 96/579/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards circulation fixtures (OJ L 254, 8.10.1996, p. 52).
Odločba Komisije 96/579/ES z dne 24. junija 1996 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s proizvodi za prometno ureditev (UL L 254, 8.10.1996, str. 52).
Commission Decision 96/580/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards curtain walling (OJ L 254, 8.10.1996, p. 56).
Odločba Komisije 96/580/ES z dne 24. junija 1996 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s predelnimi stenami (UL L 254, 8.10.1996, str. 56).
Commission Decision 96/581/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards geotextiles (OJ L 254, 8.10.1996, p. 59).
Odločba Komisije 96/581/ES z dne 24. junija 1996 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z geotekstilom (UL L 254, 8.10.1996, str. 59).
Commission Decision 96/582/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural sealant glazing systems and metal anchors for concrete (OJ L 254, 8.10.1996, p. 62).
Odločba Komisije 96/582/ES z dne 24. junija 1996 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s strukturnimi tesnjenimi zasteklitvenimi sistemi in kovinskimi sidri za beton (UL L 254, 8.10.1996, str. 62).
Commission Decision 96/603/EC of 4 October 1996 establishing the list of products belonging to classes A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 267, 19.10.1996, p. 23).
Odločba Komisije 96/603/ES z dne 4. oktobra 1996 o uvedbi seznama proizvodov, ki sodijo v razrede A Ne vplivajo na požar, predvidene v Odločbi 94/611/ES o izvajanju člena 20 Direktive Sveta 89/106/EGS o gradbenih proizvodih (UL L 267, 19.10.1996, str. 23).
Commission Decision 97/161/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal anchors for use in concrete for fixing lightweight systems (OJ L 62, 4.3.1997, p. 41).
Odločba Komisije 97/161/ES z dne 17. februarja 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov po členu 20(2) Direktive Sveta 89/106/EGS glede kovinskih sider za uporabo v betonu za pritrjevanje nenosilnih sistemov (UL L 62, 4.3.1997, str. 41).
Commission Decision 97/176/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural timber products and ancillaries (OJ L 73, 14.3.1997, p. 19).
Odločba Komisije 97/176/ES z dne 17. februarja 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z lesenimi nosilnimi in veznimi konstrukcijskimi elementi (UL L 73, 14.3.1997, str. 19).
Commission Decision 97/177/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal injection anchors for use in masonry (OJ L 73, 14.3.1997, p. 24).
Odločba Komisije 97/177/ES z dne 17. februarja 1997 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s kovinskimi injiciranimi sidri za uporabo v zidarstvu (UL L 73, 14.3.1997, str. 24).
Commission Decision 97/462/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards wood-based panels (OJ L 198, 25.7.1997, p. 27).
Odločba Komisije 97/462/ES z dne 27. junija 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z lesnimi ploščami (UL L 198, 25.7.1997, str. 27).
Commission Decision 97/463/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards plastic anchors for use in concrete and masonry (OJ L 198, 25.7.1997, p. 31).
Odločba Komisije 97/463/ES z dne 27. junija 1997 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s plastičnimi sidri za uporabo v betonu in opečnih zidovih (UL L 198, 25.7.1997, str. 31).
Commission Decision 97/464/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards waste water engineering products (OJ L 198, 25.7.1997, p. 33).
Odločba Komisije 97/464/ES z dne 27. junija 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s proizvodi za kanalizacijske sisteme (UL L 198, 25.7.1997, str. 31).
Commission Decision 97/555/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cements, building limes and other hydraulic binders (OJ L 229, 20.8.1997, p. 9).
Odločba Komisije 97/555/ES z dne 14. julija 1997 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s cementom, gradbenim apnom in drugimi hidravličnimi vezivi (UL L 229, 20.8.1997, str. 9).
Commission Decision 97/556/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards external thermal insulation composite systems/kits with rendering (ETICS) (OJ L 229, 20.8.1997, p. 14).
Odločba Komisije 97/556/ES z dne 14. julija 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z zunanjimi toplotnoizolacijskimi sestavljenimi sistemi/sklopi z ometom (UL L 229, 20.8.1997, str. 14).
Commission Decision 97/571/EC of 22 July 1997 on the general format of European Technical Approval for construction products (OJ L 236, 27.8.1997, p. 7).
Sklep Komisije 97/571/EC z dne 22. julija 1997 o splošni obliki evropskega tehničnega soglasja za gradbene proizvode (UL L 236, 27.8.1997, str. 7).
Commission Decision 97/597/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards reinforcing and prestressing steel for concrete (OJ L 240, 2.9.1997, p. 4).
Odločba Komisije 97/597/ES z dne 14. julija 1997 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z jeklom za armiranje in prednapenjanje betona (UL L 240, 2.9.1997, str. 4).
Commission Decision 97/638/EC of 19 September 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fasteners for structural timber (OJ L 268, 1.10.1997, p. 36).
Odločba Komisije 97/638/ES z dne 19. septembra 1997 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z veznimi sredstvi za stavbni les (UL L 268, 1.10.1997, str. 36).
Commission Decision 97/740/EC of 14 October 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards masonry and related products (OJ L 299, 4.11.1997, p. 42).
Odločba Komisije 97/740/ES z dne 14. oktobra 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov po členu 20(2) Direktive Sveta 89/106/EGS glede zidarskih in sorodnih proizvodov (UL L 299, 4.11.1997, str. 42).
Commission Decision 97/808/EC of 20 November 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards floorings (OJ L 331, 3.12.1997, p. 18).
Odločba Komisije 97/808/ES z dne 20. novembra 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s tlaki (UL L 331, 3.12.1997, str. 18).
Commission Decision 98/143/EC of 3 February 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards systems of mechanically fastened flexible roof waterproofing membranes (OJ L 42, 14.2.1998, p. 58).
Odločba Komisije 98/143/ES z dne 3. februarja 1998 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s sistemi mehansko pritrjenih elastičnih folij za zagotavljanje neprepustnosti streh za vodo (UL L 42, 14.2.1998, str. 58).
Commission Decision 98/213/EC of 9 March 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal partition kits (OJ L 80, 18.3.1998, p. 41).
Odločba Komisije 98/213/ES z dne 9. marca 1998 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s sklopi za predelne stene (UL L 80, 18.3.1998, str. 41).
Commission Decision 98/214/EC of 9 March 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural metallic products and ancillaries (OJ L 80, 18.3.1998, p. 46).
Odločba Komisije 98/214/ES z dne 9. marca 1998 o postopku potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi s konstrukcijskimi kovinskimi elementi in pomožnimi proizvodi (UL L 80, 18.3.1998, str. 46).
Commission Decision 98/279/EC of 5 December 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards non-load-bearing permanent shuttering kits/systems based on hollow blocks or panels of insulating materials and, sometimes, concrete (OJ L 127, 29.4.1998, p. 26).
Odločba Komisije 98/279/ES z dne 5. decembra 1997 o postopkih potrjevanja skladnosti gradbenih proizvodov v skladu s členom 20(2) Direktive Sveta 89/106/EGS v zvezi z nenosilnimi trajnimi opažnimi sklopi/sistemi, ki temeljijo na votlih blokih ali opažnih elementih iz izolacijskega materiala in včasih betona (UL L 127, 29.4.1998, str. 26).