natgillin/translations-raw huggingface dataset:
– 1. januarja 2007, če se noben tak sklep ne sprejme do 31. decembra 2006.“
– 1 January 2007, if no such decision has been adopted by 31 December 2006;”
Člen 68 – odstavek 3
Article 68 – paragraph 3
(10) Člen 68(3) se nadomesti z naslednjim:
(10) Article 68(3) is replaced by the following:
Komisija sprejme vsakršne spremembe seznama snovi iz odstavka 1.
The Commission shall adopt any amendments to the list of substances referred to in paragraph 1.
Člen 75 – odstavek 6
Article 75 – paragraph 6
(11) Člen 75(6) se nadomesti z naslednjim:
(11) Article 75(6) is replaced by the following:
Komisija lahko sprejme spremembe odstavka 5 ob upoštevanju izkušenj, pridobljenih med njegovim izvajanjem.
The Commission may amend paragraph 5 in the light of the experience gained from its operation.
Člen 79
Article 79
(12) Člen 79 se nadomesti z naslednjim:
(12) Article 79 is replaced by the following:
„Člen 79
“Article 79
Komisija sprejme vse spremembe, potrebne za posodobitev členov 72 do 78 zaradi upoštevanja znanstvenega in tehničnega napredka.
The Commission shall adopt any amendments which may be necessary to update Articles 72 to 78 to take account of scientific and technical progress.
Člen 88
Article 88
(13) Člen 88 se nadomesti z naslednjim:
(13) Article 88 is replaced by the following:
„Člen 88
“Article 88
Komisija sprejme vse potrebne spremembe, da se Priloga 1 prilagodi glede na tehnični napredek.
The Commission shall adopt any changes which are necessary in order to adapt Annex I to take account of technical progress
Uredba št. 2001/82/ES
Regulation 2001/82/EC
Člen 89
Article 89
(14) Člen 89 se spremeni:
(14) Article 89 is amended as follows:
(a) Vstavi se odstavek 2a:
(a) The following paragraph 2a is inserted:
Pri sklicevanju na ta odstavek se uporabljata člen 5a(1) do (4) in člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.“
Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision No 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof”.
(b) Odstavek 4 se nadomesti z:
(b) Paragraph 4 is replaced by the following:
Poslovnik stalnega odbora se objavi.“
The rules of procedure of the Standing Committee shall be made public.”
Uredba št. 2001/83/ES
Regulation 2001/83/EC
Člen 23 b – odstavka 2 a in 2 b (novo)
Article 23 b - paragraph 2 a and 2 b (new)
Države članice lahko še naprej uporabljajo nacionalne predpise o odstopanjih, ki veljajo na dan začetka veljavnosti te izvedbene uredbe, za dovoljenja za promet, odobrena pred 1. januarjem 1998 za zdravila, za katera je bilo izdano dovoljenje le v tej državi članici.
Member States may continue to apply national provisions on variations applicable at the time of entry into force of this implementing regulation to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State.
Kadar se za zdravilo, za katerega veljajo nacionalni predpisi v skladu s tem členom, naknadno odobri dovoljenje za promet v drugi članici, od tega datuma naprej za to zdravilo velja izvedbena uredba.
Where a medicinal product subject to national provisions in accordance with this A rticle is subsequently granted a marketing authorisation in another Member State , the implementing regulation shall apply to that medicinal product from that date.
Kadar se država članica odloči, da bo še naprej uporabljala predpise iz prejšnjega odstavka, o tem obvesti Komisijo.
Where a Member State decides to continue to apply national provisions pursuant to the previous paragraph, it shall notify the Commission thereof.
Če Komisije ne obvesti do [datuma prenosa direktive o spremembi], velja izvedbena direktiva.
If a notification has no t been made by [date of transposition of amending directive], the implementing regulation shall apply.
Direktiva 2001/83/ES
Directive 2001/83/EC
(1a) Vstavi se naslednji člen 23c:
( 1a ) The following Article 23c shall be inserted :
„Člen 23c
“ Article 23 c
Ustrezni ukrepi, ki jih je sprejela Evropska komisija v skladu s členom 23b, morajo upoštevati naslednje elemente:
The appropriate arrangements adopted by the Commission in accordance with Article 23b must take the following considerations into account :
– zaradi praktičnosti in učinkovitosti je pomembno, da se možnost vložitve ene zahteve za eno ali več enakih sprememb različnih dovoljenj za promet razširi na druge kategorije sprememb;
- f or practical reasons of efficiency, the possibility should be extended to all the categories of change of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations ;
– v zvezi z razširitvijo dovoljenja za promet je treba na podlagi utemeljitve dati možnost, da se predloži popolno in jasno vlogo za pridobitev dovoljenja za promet z zdravilom, ki je že odobreno, vendar pod drugim imenom in z drugačnim povzetkom značilnosti proizvoda.“
- as regards extensions of marketing authorisations, the possibility should be provided, on the basis of arguments in justification, of submitting a complete, separate application for authorisation for a medicinal product that has already been authorised under another name and with a different product characteristic summary.”
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje [ 12 mesecev po začetku veljavnosti].
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 12 months after entry into force] at the latest.
Komisiji takoj sporočijo besedilo navedenih predpisov in korelacijsko tabelo med navedenimi predpisi in to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje [ 18 mesecev po začetku veljavnosti].
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 18 months after entry into force] at the latest.
Komisiji takoj sporočijo besedilo navedenih predpisov in korelacijsko razpredelnico med navedenimi predpisi in to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a table showing the correlation between those provisions and this Directive.
Različni vidiki istega zdravila se skozi njegov življenjski cikel spreminjajo.
A number of aspects of a medicine may change during its life cycle.
Tehnološki napredek in novi znanstveni podatki omogočajo izboljšavo že obstoječih zdravil.
Technological progress, as well as new scientific data, offer the possibility of improving existing medicinal products.
Te spremembe so največkrat v proizvodnem postopku, v načinu čiščenja ali zadevajo možnosti za zdravljenje novih bolezni, posodabljanje informacij, namenjenih bolnikom, v zvezi z varnostjo, potem ko je prišlo do neželenih učinkov.
These changes can relate, for example, to the manufacturing process, purification methods or the introduction of a new therapeutic indication, not to mention updating of patient information leaflets to incorporate new safety information based on reported side-effects.
Krepitev farmacevtske industrije z združevanjem ali odkupi ustvarja mnogo upravnih sprememb kot na primer spremembe imen farmacevtskih družb ali njihov naslov.
In addition, consolidation of the pharmaceutical industry via mergers and acquisitions gives rise to many administrative changes, such as changes to the names or addresses of pharmaceutical companies.
Te spremembe so "preoblikovanja", ki jih mora nosilec dovoljenja za promet z zdravili obvezno sporočiti pristojnim oblastem.
All of these changes are known as ‘variations’ and must be reported to the competent authorities by the holders of authorisations to market medicinal products.
Farmacevtska industrija posveti pomemben del svojega regulativnega dela upravljanju teh sprememb.
The pharmaceutical industry devotes a large part of its regulatory work to managing these variations.
Na primer srednje veliko podjetje, ki proizvaja generična zdravila in ima na svojem seznamu več kot 400 proizvodov (vključno z različnimi farmacevtskimi oblikami in odmerki), vsako leto preseže število 4 000 vlog za spremembe.
By way of example, in the case of a medium-sized company producing generic medicines and carrying a list of 400 products (including different pharmaceutical presentations and dosages), the total number of variations submitted would exceed 4 000 per year.
Pri velikih podjetjih je to število približno 19 000.
In the case of a large company, the number would be about 19 000.
(2) Pomanjkljivosti sedanjega sistema glede zakonskih zahtev za spremembe dovoljenj za promet z zdravili
( 2) Weakness of the current system of regulatory requirements relating to changes in marketing authorisations for medicinal products
Sedanjih sistem upravlja sprememb je čedalje bolj neučinkovit in ne zadovoljuje ne oblasti ne farmacevtske industrije.
The current way of managing variations is proving increasingly inefficient and is no longer satisfactory either for the authorities or for the pharmaceutical industry as a whole.
Ker ima 80 % vseh zdravil tako v medicini kot v veterini nacionalna dovoljenja, ima ta revizija velik vpliv na trg s farmacevtskimi proizvodi v Evropski uniji.
Given that 80% of all human and veterinary medicinal products are authorised via national procedures, this revision will have a considerable impact on the pharmaceuticals market in the European Union.
Podeljevanje zgolj nacionalnih dovoljenj za promet z zdravili mora upoštevati enake zakonske zahteve kot pri dovoljenjih za promet z zdravili, podeljenih na podlagi evropskih postopkov.
The granting of purely national marketing authorisations is subject to the same regulatory requirements as marketing authorisations granted under European procedures.
Vendar pa zakonske zahteve za spremembo dovoljenj za promet z zdravili niso usklajene.
The regulatory requirements for changing marketing authorisations, on the other hand, are not harmonised.
Spremembe zgolj nacionalnih dovoljenj za promet z zdravili urejajo določbe, ki so specifične za vsako državo članico in so drugačne od evropskih zakonskih zahtev.
Changes to purely national marketing authorisations take place in accordance with provisions specific to each Member State, which are different from the European regulatory requirements.
Enaka sprememba, ki se nanaša na proizvode, ki so jih odobrile nacionalne oblasti v različnih državah članicah, se obravnava drugače, ko gre za predložitev dokumentacije in postopka za ocenjevanje.
Any one change to products authorised under national procedures in different Member States is therefore treated in a number of different ways in terms of the dossier to be submitted and the evaluation procedure.
To stanje ima negativne posledice:
This situation has some undesirable repercussions:
– dodatno in neutemeljeno upravno breme za pristojne oblasti in farmacevtska podjetja;
– an unjustified additional administrative burden for the competent authorities and pharmaceutical businesses;
– težko se predvidi izvajanje sprememb;
– logistical issues for the actual implementation of changes;
– velike razlike pri rokih za uvedbo sprememb pri povzetku značilnosti proizvoda in pri obveščanju zdravstvenega osebja in bolnikov in torej pri splošnem delovanju notranjega trga farmacevtskih proizvodov.
– widely differing deadlines for introducing changes to the summary of characteristics of the product and the information leaflet for healthcare personnel and patients, with a knock-on effect on the overall working of the single market in pharmaceutical products;
– za bolnike, ker uvedba nekaterih sprememb, ki izboljšujejo učinkovitost zdravila, lahko nastopi z zamudo ali do uvedbe sploh ne pride.
– for patients, since the introduction of some changes that improve the effectiveness of a medicine may be delayed or never happen at all.
(3) Predvidene izboljšave
(3) Planned improvements
Poročevalec aktivno podpira predlog Evropske komisije za revizijo in poenostavitev sistema sprememb v korist zdravja ljudi in živali.
The rapporteur actively supports the Commission’s proposal designed to revise and simplify the variations system for the benefit of human and animal health.
Za vsa zdravila, ne glede na postopek, v skladu s katerim so bila odobrena, morajo veljati enaka merila za vrednotenje, potrditev in upravno obravnavo v primeru sprememb.
It must be made possible for all medicinal products, whatever procedure was applied in authorising their marketing, to be subject to the same evaluation, approval and administrative-processing criteria in the event of changes being made to them.
Optimizacija sistema bo dolgoročno koristila zlasti bolnikom, saj bo na eni strani omogočila izboljšavo zdravil, na drugi pa bo imela pozitivni učinek na uporabo virov s strani pristojnih oblasti, kar bo izboljšalo varovanje javnega zdravja.
An optimisation of the system will, inter alia, be of long-term benefit to patients, in that it will encourage improvement of medicines and have a favourable impact on the use of the competent authorities’ resources with a consequent improvement in public health protection.
Poenostavitev sprememb pri dovoljenjih za promet z zdravili bo omogočila, da bodo za njihovo izdajo, administrativno upravljanje in nadzor nad uvedenimi spremembami uporabljena enaka merila ne glede na pravni postopek, s katerim so bila zdravila odobrena.
Simplifying the process of changing the terms of marketing authorisations for medicinal products will mean they are subject to the same criteria with regard to the authorisation, administrative management and supervision of the changes made, whatever the legal procedure whereby the medicinal products were licensed may have been.
Zaradi uskladitve in poenostavitve morajo vse spremembe dovoljenj za promet z zdravili potekati v skladu z enakimi zakonskimi zahtevami, ne glede na to, kateri postopek je bil uporabljen pri prvi registraciji.
For reasons of harmonisation and simplification, therefore, it is important that changes to marketing authorisations should be governed by the same regulatory requirements, whatever licensing procedure was initially used.
To bo koristilo vsem, bolnikom, oblastem in farmacevtskim podjetjem.
This will bring benefits for all concerned: patients, authorities and pharmaceutical companies.
Poleg te uskladitve za vsa zdravila je treba poenostaviti regulativni sistem za spremembe dovoljenj za promet z zdravili, zlasti za manjše spremembe, pri katerih je vpliv na kakovost, varnost ali učinkovitost zdravila zelo majhen ali ničen.
Over and above this harmonisation of all medicinal products, it is also desirable to simplify the regulatory system for handling changes to marketing authorisations, particularly in the case of minor changes whose effects on the quality, safety and effectiveness of the medicine concerned are minimal or non-existent.
Uredba Komisije o pregledu sprememb dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, sprejeta 10. junija 2008, uvaja pomembno poenostavitev sistema.
The Commission Regulation concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products adopted unanimously on 10 June 2008 significantly simplifies the system.
Za uvedbo najboljšega regulativnega sistema za upravljanje sprememb pri dovoljenjih za promet z zdravili je treba natančno določiti različne kategorije sprememb.
In order to put in place an optimal regulatory system for managing changes to marketing authorisations, it is important to define precisely the different categories of change.
Komisija predvideva oblikovanje natančnega seznama za vsako kategorijo sprememb.
The Commission provides for detailed lists to be drawn up for each category of change.
Treba je izkoristiti vse pridobljene izkušnje veljavnih nacionalnih sistemov.
It is important to capitalise on the experience acquired by the existing national systems.
Za spremembe pri nekaterih zdravilih, ki so bila odobrena z nacionalnimi postopki, nekatere države članice kot na primer Nemčija uporabljajo preprost sistem obveščanja za veliko število sprememb, za katere menijo, da so manjše.
In the case of changes relating to medicinal products licensed under national procedures, some Member States have already applied a simple notification system to a large number of changes that they regard as minor, following Germany’s example.
Ti nacionalni seznami različnih kategorij sprememb so služili kot osnova za oblikovanje evropskih seznamov.
These national lists of different types of change have been used as a basis for drawing up the European lists.
Komisija predlaga določeno število pomembnih izboljšav regulativnega sistema za upravljanje sprememb dovoljenj za promet z zdravili ter se je pri oblikovanju svoje uredbe zgledovala po nemškem primeru.
The Commission proposes a number of significant improvements to the regulatory system for managing changes to marketing authorisations, also following the German example closely in the regulation.
Zaradi razlogov, ki se nanašajo na sorazmerje, so homeopatska zdravila in tradicionalna zdravila na podlagi zelišč, ki niso dobila dovoljenj za promet, vendar spadajo v poenostavljen postopek za registracijo, izključena s področja izvajanja uredbe.
For reasons of proportionality, homeopathic medicines and traditional herbal medicines which have not received a marketing authorisation, but are subject to a simplified registration procedure, continue to be excluded from the regulation’s scope.
Poročevalka izraža zadovoljstvo zaradi te določbe, ker se je tako mogoče izogniti zapletenosti postopka registracije, ki je v nekaterih državah članicah bolj preprost.
The rapporteur welcomes this, because it avoids complicating a registration procedure which was simpler in some Member States.
Vendar bi se dalo še izboljšati predlagani sistem, če bi ena zahteva za spremembo lahko pokrivala več dovoljenj za promet z zdravili.
Nonetheless, an additional improvement could be made to the system proposed in cases where a change relates to a number of marketing authorisations, with the possibility of a single submission covering all the marketing authorisations.
V svoji uredbi Komisija predvideva omejitev te možnosti na manjše spremembe vrste IA, vendar zato, da tak ukrep prinese korist (zmanjšanje upravnega bremena ter lažja ocena spremembe in njeno izvajanje za vse zadevne proizvode) je treba razširiti to možnost na druge kategorije sprememb: manjše spremembe vrste IB ter večje spremembe vrste II.
However, in order to obtain the full benefit of such a measure (lighter administrative burden and greater ease in considering and simultaneously applying the change to all the products concerned), it is important that this possibility should be extended to the other categories of change: minor Type‑IB changes and major Type-II changes.
To predlaga Komisija v okviru postopka za delitev nalog iz člena 20.
This is only proposed by the Commission in the context of the worksharing procedure described in Article 20.
Če je dovoljenja za promet z zdravili odobrila sama država članica z nacionalnim postopkom, ni upravičena zahteva, da se delijo naloge, saj bi se to moralo omejiti le na spremembe dovoljenj za promet z zdravili, ki jih je odobrilo več držav članic ali z različnimi postopki pri začetni registraciji.
Where the marketing authorisations concerned were granted under a national procedure by the same Member State, there is no justification for using this worksharing procedure, which should be reserved for changes relating to marketing authorisations granted by different Member States or under different initial registration procedures.
Le v takem kontekstu je vidna korist od odprave različnih ocen, ki jih različne pristojne oblasti opravijo za eno samo ali za skupino sprememb.
It is only in this context that there is a benefit in terms of dealing with the plethora of evaluations by different competent authorities of the same change or group of changes.
Pri razširitvi dovoljenj za promet z zdravili Komisija predlaga, naj ime zdravila ostane enako kot pri izdaji prvega dovoljenja (člen 19).
As regards extensions of marketing authorisations, the Commission proposes that the medicinal product should retain the same name as in the initial marketing authorisation (Article 19).
V sedanjem sistemu uredbi (ES) št. 1084/2003 (uvodna izjava 8) in št. 1085/2003 (uvodna izjava 6) predvidevata, da se za razširitev dovoljenja za promet z zdravilom predloži popolno in jasno vlogo za zdravilo, ki je že odobreno, vendar pod drugim imenom in z drugačnim povzetkom glavnih značilnosti proizvoda.
Under the current system, Regulations (EC) No 1084/2003 (recital 8) and No 1085/2003 (recital 6) provide for the possibility, in the case of an extension of a marketing authorisation, of filing a complete, separate request for authorisation of a medicinal product that has already been authorised, but under another name and with a different product characteristic summary.
To možnost, ki jo nudi sedanji sistem, je treba ohraniti.
It is essential that this possibility available under the present system should be retained.
V nekaterih primerih je lahko pomembno, da se razširitev dovoljenja za promet z zdravili, ki se nanaša na drugačno indikacijo, kot je bila začetna, registrira z drugačnim imenom, kot je bilo navedeno za prvo dovoljenje za promet.
In some cases it can be important to register an extension of a marketing authorisation under a different name where it concerns an indication different from that initially registered in the original marketing authorisation.
Nekatera imena zdravil so zelo povezana z določeno boleznijo, zato bi lahko bilo škodljivo za bolnika, če bi bilo treba ohraniti isto ime za drugačno bolezen.
Some medicine names have strong associations to a certain pathology, and it could have a damaging effect on patients if the same name were kept when the pathology treated by the medicine had changed completely.
Za sedaj velja usklajena evropska zakonodaja zgolj za majhen odstotek zdravil (približno 20 %, in sicer gre za zdravila, za katera se je dovoljenje izdalo v skladu z dvema sprejetima postopkoma, „centraliziranim postopkom“ in „vzajemnim priznanjem“).
So far, only a small proportion of the medicinal products are subject to harmonized European legislation (around 20 %, i.e. those products that had received their authorisation in accordance with two accepted procedures, "centralised" and "mutual recognition").
Za proizvode, ki imajo izključno nacionalna dovoljenja, veljavna evropska zakonodaja o spremembah ne velja, zato jih obravnavajo posebna in med seboj razlikujoča se nacionalna pravila.
Those products that have a purely national authorisation are not regulated by the current European legislation on variations and subsequently are dealt with through specific and varying national rules.
To je neučinkovito, povzroča precejšnje gospodarske stroške, poleg tega pa vpliva na pravilno delovanje notranjega trga.
This is both inefficient and lead to significant economic costs, in addition to affecting the proper functioning of the internal market.
Ta direktiva bi zagotovila pravno podlago za usklajevanje in pri vseh vrstah sprememb omogočila sprejetje izvedbenih ukrepov s komitologijo.
The present directive would grant legal basis for harmonisation and would permit for the adoption of implementing measures through comitology with regards to all types of variations.
Pripravljavka mnenja podpira usklajevanje, ki bo potrošnikom in industriji zelo koristilo ter bo v državah članicah pospešilo dostop do najnovejših zdravil.
The rapporteur is in favour of harmonisation, which will bring great benefits to both consumers and industry and would speed up the access to the latest medicines across the Member States.