natgillin/translations-raw huggingface dataset:
any denunciation of, or amendments to, these agreements or arrangements.
vsako odpoved ali spremembo teh sporazumov ali dogovorov.
Legal aid
Pravna pomoč
This Regulation shall not affect the application of Article 23 of the Convention on civil procedure of 17 July 1905, Article 24 of the Convention on civil procedure of 1 March 1954 or Article 13 of the Convention on international access to justice of 25 October 1980 between the Member States party to those Conventions.
Ta uredba ne vpliva na uporabo člena 23 Konvencije o civilnem postopku z dne 17. julija 1905, člena 24 Konvencije o civilnem postopku z dne 1. marca 1954 ali člena 13 Konvencije o mednarodnem dostopu do sodišča z dne 25. oktobra 1980 med državami članicami, ki so pogodbenice teh konvencij.
Protection of information transmitted
Varstvo poslanih informacij
Information, including in particular personal data, transmitted under this Regulation shall be used by the receiving agency only for the purpose for which it was transmitted.
Informacije, zlasti osebne podatke, ki se pošiljajo po tej uredbi, sme organ za sprejem uporabiti samo za namen, za katerega so bili poslani.
Receiving agencies shall ensure the confidentiality of such information, in accordance with their national law.
Organi za sprejem zagotovijo zaupnost teh informacij v skladu s svojim nacionalnim pravom.
Paragraphs 1 and 2 shall not affect national laws enabling data subjects to be informed of the use made of information transmitted under this Regulation.
Odstavka 1 in 2 ne vplivata na nacionalno pravo, ki omogoča subjektom, na katere se osebni podatki nanašajo, da so obveščeni o uporabi informacij, poslanih po tej uredbi.
This Regulation shall be without prejudice to Directives 95/46/EC and 2002/58/EC.
Ta uredba ne posega v direktivi 95/46/ES in 2002/58/ES.
Communication and publication
Sporočanje in objava
Member States shall communicate to the Commission the information referred to in Articles 2, 3, 4, 10, 11, 13, 15 and 19.
Države članice sporočijo Komisiji informacije iz členov 2, 3, 4, 10, 11, 13, 15 in 19.
Member States shall communicate to the Commission if, according to their law, a document has to be served within a particular period as referred to in Articles 8(3) and 9(2).
Države članice sporočijo Komisiji, če se po njihovi zakonodaji pisanje v skladu s členoma 8(3) in 9(2) vroči v določenem roku.
The Commission shall publish the information communicated in accordance with paragraph 1 in the Official Journal of the European Union with the exception of the addresses and other contact details of the agencies and of the central bodies and the geographical areas in which they have jurisdiction.
Komisija informacije, sporočene v skladu z odstavkom 1, objavi v Uradnem listu Evropske unije, razen naslovov in drugih kontaktnih informacij organov in osrednjih organov ter geografskih območjih, za katera so ti pristojni.
The Commission shall draw up and update regularly a manual containing the information referred to in paragraph 1, which shall be available electronically, in particular through the European Judicial Network in Civil and Commercial Matters.
Komisija sestavi in redno posodablja priročnik, ki vsebuje informacije iz odstavka 1 in je na voljo v elektronski obliki, zlasti prek Evropske pravosodne mreže v civilnih in gospodarskih zadevah.
No later than 1 June 2011, and every five years thereafter, the Commission shall present to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Regulation, paying special attention to the effectiveness of the agencies designated pursuant to Article 2 and to the practical application of Article 3(c) and Article 9.
Komisija najpozneje do 1. junija 2011 in potem vsakih pet let Evropskemu parlamentu, Svetu in Evropskemu ekonomsko-socialnemu odboru predloži poročilo o izvajanju te uredbe, ob tem pa posebno pozornost nameni učinkovitosti organov, imenovanih v skladu s členom 2, in praktičnemu izvajanju člena 3(c) in člena 9.
The report shall be accompanied if need be by proposals for adaptations of this Regulation in line with the evolution of notification systems.
Poročilo po potrebi spremljajo predlogi za prilagoditve te uredbe razvoju sistemov obveščanja.
Regulation (EC) No 1348/2000 shall be repealed as from the date of application of this Regulation.
Uredba (ES) št. 1348/2000 se razveljavi z dnem začetka uporabe te uredbe.
References made to the repealed Regulation shall be construed as being made to this Regulation and should be read in accordance with the correlation table in Annex III.
Sklicevanja na razveljavljeno uredbo se štejejo za sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge III.
It shall apply from 13 November 2008 with the exception of Article 23 which shall apply from 13 August 2008.
Uporablja se od 13. novembra 2008, razen člena 23, ki se uporablja od 13. avgusta 2008.
OJ C 88, 11.4.2006, p. 7.
UL C 88, 11.4.2006, str. 7.
Opinion of the European Parliament of 4 July 2006 (OJ C 303 E, 13.12.2006, p. 69), Council Common Position of 28 June 2007 (OJ C 193 E, 21.8.2007, p. 13) and Position of the European Parliament of 24 October 2007.
Mnenje Evropskega parlamenta z dne 4. julija 2006 (UL C 303 E, 13.12.2006, str. 69), Sklep Sveta z dne 28. junija 2007 (UL C 193 E, 21.8.2007, str. 13) in Stališče Evropskega parlamenta z dne 24. oktobra 2007.
OJ C 261, 27.8.1997, p. 1.
UL C 261, 27.8.1997, str. 1.
On the same day as the Convention was drawn up the Council took note of the explanatory report on the Convention which is set out on page 26 of the aforementioned Official Journal.
Svet se je na isti dan, kot je bila pripravljena Konvencija, seznanil z obrazložitvenim poročilom o Konvenciji, ki je objavljeno na strani 26 prej navedenega Uradnega lista.
Brussels Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (OJ L 299, 31.12.1972, p. 32; consolidated version, OJ C 27, 26.1.1998, p. 1).
Bruseljska konvencija z dne 27. septembra 1968 o sodni pristojnosti ter izvrševanju sodb v civilnih in gospodarskih zadevah (UL L 299, 31.12.1972, str. 32; prečiščena različica v UL C 27, 26.1.1998, str. 1).
Hague Convention of 15 November 1965 on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters.
Haaška konvencija z dne 15. novembra 1965 o vročitvi sodnih in zunajsodnih listin v civilnih ali gospodarskih zadevah v tujini.
REQUEST FOR SERVICE OF DOCUMENTS
ZAPROSILO ZA VROČITEV PISANJ
(Article 4(3) of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (1))
(Člen 4(3) Uredbe (ES) št. 1393/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o vročanju sodnih in izvensodnih pisanj v civilnih ali gospodarskih zadevah v državah članicah (1))
Reference No: …
Referenčna št.: …
TRANSMITTING AGENCY
ORGAN ZA POŠILJANJE
identity
Ime:
address
Naslov:
street and number/PO box
Ulica in številka/poštni predal:
place and post code
Kraj in poštna številka:
country
Država:
fax (*)
Faks (*):
e-mail (*)
Elektronska pošta (*):
RECEIVING AGENCY
ORGAN ZA SPREJEM
APPLICANT
PROSILEC
This item is optional.
Ni obvezno.
ADDRESSEE
NASLOVNIK
identification number/social security number/organisation number/or equivalent (*)
Identifikacijska številka/številka socialnega zavarovanja/številka organizacije/ali podobno (*):
METHOD OF SERVICE
NAČIN VROČITVE
in accordance with the law of the Member State addressed
V skladu s pravom zaprošene države članice
by the following particular method
Na naslednji poseben način:
if this method is incompatible with the law of the Member State addressed, the document(s) should be served in accordance with the law of that Member State.
Če ta način ni združljiv s pravom zaprošene države članice, je treba pisanje(-a) vročiti v skladu s pravom te države članice:
DOCUMENT TO BE SERVED
PISANJE ZA VROČITEV
nature of the document
Vrsta pisanja
judicial
sodno
writ of summons
pisanje, na podlagi katerega se začne postopek
judgment
sodba
appeal
pritožba
extrajudicial
izvensodno
date or time limit after which service is no longer required (*)
Datum ali rok, po katerem vročanje ni več potrebno (*):
… (day) … (month) … (year)
… (dan) … (mesec) … (leto)
language of document
Jezik pisanja:
original (BG, ES, CS, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV, other):
izvirnik (BG, ES, CS, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV, drugo):
translation (*) (BG, ES, CS, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV, other):
prevod (*) (BG, ES, CS, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV, drugo):
number of enclosures
Število prilog:
A COPY OF DOCUMENT TO BE RETURNED WITH THE CERTIFICATE OF SERVICE (Article 4(5) of Regulation (EC) No 1393/2007)
IZVOD PISANJA SE VRNE SKUPAJ S POTRDILOM O VROČITVI (člen 4(5) Uredbe (ES) št. 1393/2007)
yes (in this case send two copies of the document to be served)
Da (v tem primeru je treba poslati dva izvoda pisanja za vročitev)
You are required by Article 7(2) of Regulation (EC) No 1393/2007 to take all necessary steps to effect the service of the document as soon as possible, and in any event within one month of receipt.
V skladu s členom 7(2) Uredbe (ES) št. 1393/2007 morate sprejeti vse ukrepe za vročitev pisanja čim prej in v vsakem primeru v enem mesecu po prejemu.
If it has not been possible for you to effect service within one month of receipt, you must inform this agency by indicating this in point 13 of the certificate of service or non-service of documents.
Če vročitev v enem mesecu po prejemu ni bila mogoča, morate o tem z navedbo v točki 13 potrdila o vročitvi ali nevročitvi pisanj obvestiti ta organ.
If you cannot fulfil this request for service on the basis of the information or documents transmitted, you are required by Article 6(2) of Regulation (EC) No 1393/2007 to contact this agency by the swiftest possible means in order to secure the missing information or document.
Če na podlagi poslanih informacij ali pisanj tega zaprosila za vročitev ne morete izpolniti, morate v skladu s členom 6(2) Uredbe (ES) št. 1393/2007 po najhitrejši možni poti stopiti v stik s tem organom, da se zagotovijo manjkajoče informacije ali pisanja.
Signature and/or stamp …
Podpis in/ali žig: …
Reference No of the transmitting agency …
Referenčna številka organa za pošiljanje: …
Reference No of the receiving agency …
Referenčna številka organa za sprejem: …
(Article 6(1) of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters)
(Člen 6(1) Uredbe (ES) št. 1393/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o vročanju sodnih in izvensodnih pisanj v civilnih ali gospodarskih zadevah v državah članicah)
This acknowledgement must be sent by the swiftest possible means of transmission as soon as possible after receipt of the document and in any event within seven days of receipt.
To potrdilo je treba poslati po najhitrejši možni poti čim prej po prejemu pisanja, v vsakem primeru pa v sedmih dneh po prejemu.
DATE OF RECEIPT
DATUM PREJEMA:
NOTICE OF RETURN OF REQUEST AND DOCUMENT
OBVESTILO O VRAČILU ZAPROSILA IN PISANJA
(Article 6(3) of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (1))
(Člen 6(3) Uredbe (ES) št. 1393/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o vročanju sodnih in izvensodnih pisanj v civilnih ali gospodarskih zadevah v državah članicah (1))
The request and document must be returned on receipt.
Zaprosilo in pisanje je treba vrniti takoj po prejemu.
REASON FOR RETURN
RAZLOG VRAČILA:
the request is manifestly outside the scope of the Regulation
Zaprosilo je očitno izven področja uporabe uredbe:
the document is not civil or commercial
pisanje se ne nanaša na civilno ali gospodarsko zadevo
the service is not from one Member State to another Member State
ne gre za vročitev iz ene države članice v drugo državo članico
non-compliance with the formal conditions required makes service impossible
Neizpolnjevanje zahtevanih formalnih pogojev onemogoča vročitev:
the document is not easily legible
pisanje je slabo čitljivo
the language used to complete the form is incorrect
obrazec je izpolnjen v nesprejemljivem jeziku
the document received is not a true and faithful copy
prejeto pisanje ni istovetno z izvirnikom
other (please give details)
drugo (prosimo, navedite podrobnosti):
the method of service is incompatible with the law of the Member State addressed (Article 7(1) of Regulation (EC) No 1393/2007)
Način vročitve je v nasprotju s pravom zaprošene države članice (člen 7(1) Uredbe (ES) št. 1393/2007)
Reference No of the transmitting agency: …
Referenčna številka organa za pošiljanje: …
Reference No of the receiving agency: …
Referenčna številka organa za sprejem: …
NOTICE OF RETRANSMISSION OF REQUEST AND DOCUMENT TO THE APPROPRIATE RECEIVING AGENCY
OBVESTILO O POSREDOVANJU ZAPROSILA IN PISANJA PRISTOJNEMU ORGANU ZA SPREJEM
(Article 6(4) of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (1))
(Člen 6(4) Uredbe (ES) št. 1393/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o vročanju sodnih in izvensodnih pisanj v civilnih ali gospodarskih zadevah v državah članicah (1))
The request and document were forwarded to the following receiving agency, which has territorial jurisdiction to serve it:
Zaprosilo in pisanje sta bili posredovani naslednjemu organu za sprejem, ki je krajevno pristojen za vročitev:
APPROPRIATE RECEIVING AGENCY
PRISTOJNI ORGAN ZA SPREJEM
Reference No of the appropriate receiving agency: …
Referenčna številka pristojnega organa za sprejem: …
NOTICE OF RECEIPT BY THE APPROPRIATE RECEIVING AGENCY HAVING TERRITORIAL JURISDICTION TO THE TRANSMITTING AGENCY
POTRDILO O PREJEMU KRAJEVNO PRISTOJNEGA ORGANA ZA SPREJEM ORGANU ZA POŠILJANJE
This notice must be sent by the swiftest possible means of transmission as soon as possible after receipt of the document and in any event within seven days of receipt.
To potrdilo je treba poslati po najhitrejši možni poti čim prej po prejemu pisanja, v vsakem primeru pa v sedmih dneh po prejemu.
CERTIFICATE OF SERVICE OR NON-SERVICE OF DOCUMENTS
POTRDILO O VROČITVI ALI NEVROČITVI PISANJ
(Article 10 of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (1))
(Člen 10 Uredbe (ES) št. 1393/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o vročanju sodnih in izvensodnih pisanj v civilnih ali gospodarskih zadevah v državah članicah (1))
The service shall be effected as soon as possible.
Vročitev je treba opraviti čim prej.
If it has not been possible to effect service within one month of receipt, the receiving agency shall inform the transmitting agency (Article 7(2) of Regulation (EC) No 1393/2007)
Če vročitve ni bilo mogoče opraviti v enem mesecu po prejemu, organ za sprejem o tem obvesti organ za pošiljanje (v skladu s členom 7(2) Uredbe (ES) št. 1393/2007)
COMPLETION OF SERVICE
IZVEDBA VROČITVE
date and address of service
Datum in naslov vročitve:
the document was
Pisanje je bilo
served in accordance with the law of the Member State addressed, namely
vročeno v skladu s pravom zaprošene države članice, in sicer
handed to
izročeno
the addressee in person
naslovniku osebno
another person
drugi osebi
name
Ime:
relation to the addressee
Razmerje do naslovnika:
family … employee … other …
družinski član … uslužbenec … drugo …
the addressee’s address
na naslovu naslovnika
served by postal services
vročeno z uporabo poštnih storitev
without acknowledgement of receipt
brez potrdila o prejemu
with the enclosed acknowledgement of receipt
s priloženim potrdilom o prejemu
from the addressee
s strani naslovnika
from another person
s strani druge osebe
served by another method (please state how)
vročeno na drug način (prosimo, pojasnite kako):
served by the following particular method (please state how)
vročeno na naslednji način (prosimo, pojasnite kako):
The addressee of the document was informed in writing that he may refuse to accept the document if it is not written in or accompanied by a translation into either a language which he understands or the official language or one of the official languages of the place of service.
Naslovnik pisanja je bil pisno poučen, da lahko zavrne sprejem pisanja, če ni sestavljeno v jeziku, ki ga naslovnik razume, ali v uradnem jeziku ali v enem od uradnih jezikov kraja vročitve, oziroma če ji ni priložen prevod v enega od teh jezikov.
INFORMATION IN ACCORDANCE WITH ARTICLE 7(2) of Regulation (EC) No 1393/2007
OBVESTILO V SKLADU S ČLENOM 7(2) Uredbe (ES) št. 1393/2007
It was not possible to effect service within one month of receipt.
Vročitve ni bilo mogoče opraviti v enem mesecu po prejemu.
REFUSAL OF DOCUMENT
ZAVRNITEV PISANJA
The addressee refused to accept the document on account of the language used.
Naslovnik je zavrnil sprejem pisanja zaradi uporabljenega jezika.
The document is annexed to this certificate.
Pisanje je priloženo temu potrdilu.
REASON FOR NON-SERVICE OF DOCUMENT
RAZLOG ZA NEVROČITEV PISANJA
address unknown
Naslov neznan
addressee cannot be located
Naslovnika ni mogoče najti
document could not be served before the date or time limit stated in point 6.2.
Pisanja ni bilo mogoče vročiti pred datumom ali v roku iz točke 6.2.
other (please specify)
Drugo (prosimo, navedite podrobnosti):
INFORMATION TO THE ADDRESSEE ABOUT THE RIGHT TO REFUSE TO ACCEPT A DOCUMENT
OBVESTILO NASLOVNIKA GLEDE PRAVICE DO ZAVRNITVE SPREJEMA PISANJA
(Article 8(1) of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (1))
(Člen 8(1) Uredbe (ES) št. 1393/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o vročanju sodnih in izvensodnih pisanj v civilnih ali gospodarskih zadevah v državah članicah (1))
The information contained in this Annex would have read as follows in Danish if the Regulation had applied in Denmark:
Obvestilo iz te priloge bi se v primeru, da bi se uredba uporabljala na Danskem, v danščini glasilo:
Regulation (EC) No 1348/2000
Uredba (ES) št. 1348/2000
Article 1(1) second sentence
člen 1(1), drugi stavek
Article 7(2) first sentence
člen 7(2), prvi stavek
Article 7(2) second sentence
člen 7(2), drugi stavek
Article 7(2) second sentence (introductory phrase) and Article 7(2)(a)
člen 7(2), drugi stavek (uvodni stavek) in člen 7(2)(a)
Article 7(2)(b)
člen 7(2)(b)
Article 7(2) third sentence
člen 7(2), tretji stavek
Article 8(1) introductory phrase
člen 8(1), uvodni stavek
Article 8(3) to (5)
člen 8(3) do (5)
Article 11(2) first subparagraph
člen 11(2), prvi pododstavek
Article 11(2) second subparagraph
člen 11(2), drugi pododstavek
Article 17, introductory phrase
člen 17, uvodni stavek
Article 17(a) to (c)
člen 17(a) do (c)
Article 18(1) and (2)
člen 18(1) in (2)
Article 23(1) first sentence
člen 23(1), prvi stavek
Article 23(1) second sentence
člen 23(1), drugi stavek
Regulation (EC) No 1394/2007 of the European Parliament and of the Council
Uredba (ES) št. 1394/2007 Evropskega parlamenta in Sveta
on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
New scientific progress in cellular and molecular biotechnology has led to the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering.
Nov znanstveni napredek v celični in molekularni biotehnologiji je povzročil razvoj naprednih oblik zdravljenja, kot so gensko zdravljenje, somatsko celično zdravljenje in tkivno inženirstvo.
This nascent field of biomedicine offers new opportunities for the treatment of diseases and dysfunctions of the human body.
To razvijajoče se področje biomedicine nudi nove možnosti zdravljenja bolezni in motenj človeškega telesa.
Insofar as advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [3], read in conjunction with the definition of medicinal products in Article 1(2) thereof.
Če imajo izdelki za napredno zdravljenje lastnosti za zdravljenje ali preprečevanje bolezni ljudi ali za uporabo pri ljudeh ali dajanje ljudem za ponovno vzpostavitev, izboljšanje ali spreminjanje fizioloških funkcij prek predvsem farmakološkega, imunološkega ali presnovnega delovanja, se štejejo za biološka zdravila v smislu Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [3], in v povezavi z opredelitvijo zdravila iz člena 1(2) navedene direktive.
Thus, the essential aim of any rules governing their production, distribution and use must be to safeguard public health.
Zato mora biti osnovni cilj kakršnih koli predpisov, ki urejajo njihovo izdelavo, promet in uporabo, varovanje javnega zdravja.
For reasons of clarity, complex therapeutic products require precise legal definitions.
Zaradi jasnosti je treba kompleksne izdelke za zdravljenje natančno pravno opredeliti.
Gene therapy medicinal products and somatic cell therapy medicinal products have been defined in Annex I to Directive 2001/83/EC, but a legal definition of tissue engineered products remains to be laid down.
Zdravila za gensko zdravljenje in zdravila za somatsko celično zdravljenje so opredeljena v Prilogi I k Direktivi 2001/83/ES, potrebna pa je še pravna opredelitev izdelkov tkivnega inženirstva.
When products are based on viable cells or tissues, the pharmacological, immunological or metabolic action should be considered as the principal mode of action.
Če so izdelki narejeni na osnovi živih celic ali tkiv, se farmakološko, imunološko ali presnovno delovanje teh celic ali tkiv upošteva kot glavni način delovanja.
It should also be clarified that products which do not meet the definition of a medicinal product, such as products made exclusively of non-viable materials which act primarily by physical means, cannot by definition be advanced therapy medicinal products.
Treba bi bilo tudi pojasniti, da izdelki, ki niso opredeljeni kot zdravila, kot so izdelki, narejeni izključno iz neživih snovi in katerih način delovanja je predvsem fizikalen, ne morejo biti opredeljeni kot zdravila za napredno zdravljenje.
According to Directive 2001/83/EC and the Medical Device Directives the basis for deciding which regulatory regime is applicable to combinations of medicinal products and medical devices is the principal mode of action of the combination product.
V skladu z Direktivo 2001/83/ES in direktivami o medicinskih pripomočkih se za kombinacije zdravil in medicinskih pripomočkov določi, katera zakonodajna ureditev se bo uporabljala, na podlagi tega, kateri je glavni način delovanja kombiniranega izdelka.
However, the complexity of combined advanced therapy medicinal products containing viable cells or tissues requires a specific approach.
Vendar pa je zaradi kompleksnosti kombiniranih zdravil za napredno zdravljenje, ki vsebujejo živa tkiva ali celice, potreben poseben pristop.