natgillin/translations-raw huggingface dataset:
Description of case
Opis primera
Involved Member States
Vpletene države članice
Outcome of the investigation and final conclusion
Rezultat preiskave in končne ugotovitve
Preventive and corrective actions taken
Sprejeti preventivni in popravni ukrepi
Conclusion/Follow-up, if required
Sklep/po potrebi nadaljnji ukrepi
Directive 2012/26/EU of the European Parliament and of the Council
Direktiva 2012/26/EU Evropskega parlamenta in Sveta
amending Directive 2001/83/EC as regards pharmacovigilance
o spremembi Direktive 2001/83/ES, kar zadeva farmakovigilanco
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 114 in člena 168(4)(c) Pogodbe,
Recent pharmacovigilance incidents in the Union have shown the need for an automatic procedure at Union level in cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised.
Nedavni incidenti na področju farmakovigilance v Uniji so pokazali na potrebo po samodejnem postopku na ravni Unije za primere posebnih varnostnih vprašanj za zagotovitev, da se zadeva oceni in obravnava v vseh državah članicah, v katerih je zdravilo odobreno.
The scope of different Union procedures concerning products authorised at national level, as laid down in 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], should be clarified.
Treba bi bilo razjasniti področje uporabe različnih postopkov Unije v zvezi z zdravili, odobrenimi na nacionalni ravni, določenih v 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 addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States.
Poleg tega prostovoljno ukrepanje imetnika dovoljenja za promet ne bi smelo povzročiti, da zadržki, povezani s tveganji ali koristmi zdravila, odobrenega v Uniji, niso ustrezno obravnavani v vseh državah članicah.
Therefore, the marketing authorisation holder should be obliged to inform the relevant competent authorities and the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation.
Zato bi moral biti imetnik dovoljenja za promet dolžan zadevne pristojne organe in Evropsko agencijo za zdravila obvestiti o razlogih za umik zdravila ali prekinitev dajanja zdravila v promet, zahtevo za ukinitev dovoljenja za promet ali nepodaljšanje dovoljenja za promet.
It is appropriate to further clarify and strengthen the Normal Procedure and the Urgent Union Procedure in order to ensure coordination, swift assessment in case of urgency and the possibility to take immediate action, where necessary to protect public health, before a decision is taken at Union level.
Primerno je bolje pojasniti ter okrepiti običajni postopek in nujni postopek Unije, da se zagotovi usklajevanje, hitro oceno v nujnih primerih ter možnost takojšnega ukrepanja, ko je to potrebno za zavarovanje javnega zdravja, še pred sprejetjem odločitve na ravni Unije.
The Normal Procedure should be initiated for matters concerning quality, safety or efficacy of medicinal products where the interests of the Union are involved.
Običajni postopek bi bilo treba začeti v zadevah v zvezi s kakovostjo, varnostjo ali učinkovitostjo zdravil, kadar so vključeni interesi Unije.
The Urgent Union Procedure should be initiated when there is a need to swiftly assess concerns resulting from the evaluation of data from pharmacovigilance activities.
Nujni postopek Unije bi bilo treba začeti, ko je potrebna hitra ocena zadržkov, ki izhajajo iz ocene podatkov, pridobljenih iz dejavnosti farmakovigilance.
Regardless of whether the Urgent Union Procedure or the Normal Procedure is applied, and regardless of the procedure by means of which the medicinal product was authorised, be it centralised or otherwise, the Pharmacovigilance Risk Assessment Committee should always give its recommendation when the reason for taking action is based on pharmacovigilance data.
Ne glede na to, ali se uporabi nujni postopek Unije ali običajni postopek in ne glede na postopek, s katerim se je zdravilo odobrilo, bodisi centraliziran ali drug postopek, bi moral Odbor za ocenjevanje tveganja na področju farmakovigilance vedno podati priporočilo, ko so farmakovigilančni podatki razlog za ukrepanje.
It is appropriate that the coordination group and the Committee for Medicinal Products for Human Use rely on that recommendation when carrying out the assessment of the issue.
Primerno je, da se skupina za usklajevanje in Odbor za zdravila za uporabo v humani medicini pri ocenjevanju vprašanja opreta na to priporočilo.
It is appropriate that Member States bring cases concerning new contraindications, reductions in the recommended dose or restrictions to the indication for medicinal products authorised in accordance with the decentralised procedure and the mutual recognition procedure to the attention of the coordination group when the Urgent Union Procedure is not initiated.
Primerno je, da države članice opozorijo skupino za usklajevanje na primere novih kontraindikacij, zmanjšanja priporočenega odmerka ali omejitve indikacij za zdravila, odobrena v skladu z decentraliziranim postopkom in postopkom z medsebojnim priznavanjem, ko nujni postopek Unije ni začet.
In order to ensure harmonisation for those products, the coordination group may discuss whether any action is necessary in the event that no Member State has triggered the Normal Procedure.
V primeru, da nobena od držav članic ni sprožila običajnega postopka, lahko skupina za usklajevanje razpravlja, ali je potrebno ukrepanje za zagotavljanje harmonizacije teh zdravil.
Since the objective of this Directive, namely to harmonise the rules on pharmacovigilance across the Union, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker cilja te direktive, in sicer harmonizacije pravil o farmakovigilanci po vsej Uniji, države članice ne morejo zadovoljivo doseči in ker se ta cilj lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Directive 2001/83/EC should therefore be amended accordingly,
Direktivo 2001/83/ES bi bilo treba zato ustrezno spremeniti –
in Article 23a, the second paragraph is replaced by the following:
v členu 23a se drugi odstavek nadomesti z naslednjim: "Če zdravilo ni več dano v promet v državi članici, bodisi začasno ali stalno, imetnik dovoljenja za promet obvesti pristojni organ zadevne države članice. Razen v izjemnih okoliščinah se tako obvestilo pošlje najmanj dva meseca pred prekinitvijo dajanja zdravila v promet.
‘If the product ceases to be placed on the market of a Member State, either temporarily or permanently, the marketing authorisation holder shall notify the competent authority of that Member State. Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The marketing authorisation holder shall inform the competent authority of the reasons for such action in accordance with Article 123(2).’;
Imetnik dovoljenja za promet pristojni organ obvesti o razlogih za tako ukrepanje v skladu s členom 123(2).";
‘However, where one of the criteria listed in Article 107i(1) is met, the procedure laid down in Articles 107i to 107k shall apply.’;
"Kadar pa je izpolnjeno eno od meril iz člena 107i(1), se uporabi postopek iz členov 107i do 107k.";
Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation.
Kadar se odboru v obravnavo predloži niz zdravil ali terapevtska skupina, lahko Agencija omeji postopek na nekatere posebne dele dovoljenja za promet.
In that event, Article 35 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in this Chapter.
V tem primeru se člen 35 za ta zdravila uporabi samo, če jih zajemajo postopki izdaje dovoljenja iz tega poglavja.
Where the scope of the procedure initiated under this Article concerns a range of medicinal products or a therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure.
Kadar področje uporabe postopka, začetega na podlagi tega člena, zadeva niz zdravil ali terapevtsko skupino, so v postopek vključena tudi zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, ki sodijo v navedeni niz ali skupino.
Without prejudice to paragraph 1, a Member State may, where urgent action is necessary to protect public health at any stage of the procedure, suspend the marketing authorisation and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted.
Brez poseganja v odstavek 1 lahko država članica, če je v kateri koli fazi postopka potrebno nujno ukrepanje za zavarovanje javnega zdravja, začasno odvzame dovoljenje za promet z zdravilom in prepove uporabo zadevnega zdravila na svojem ozemlju do sprejetja dokončne odločitve.
It shall inform the Commission, the Agency and the other Member States, no later than the following working day, of the reasons for its action.
O razlogih za tako ukrepanje obvesti Komisijo, Agencijo in druge države članice najpozneje naslednji delovni dan.
Where the scope of the procedure initiated under this Article, as determined in accordance with paragraph 2, includes medicinal products authorised in accordance with Regulation (EC) No 726/2004, the Commission may, where urgent action is necessary to protect public health, at any stage of the procedure, suspend the marketing authorisations and prohibit the use of the medicinal products concerned until a definitive decision is adopted.
Kadar področje uporabe postopka, začetega na podlagi tega člena, kakor je določeno v skladu z odstavkom 2, vključuje zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, lahko Komisija, če je v kateri koli fazi postopka potrebno nujno ukrepanje za zavarovanje javnega zdravja, začasno odvzame dovoljenje za promet in prepove uporabo zadevnega zdravila do sprejetja dokončne odločitve.
The Commission shall inform the Agency and the Member States no later than the following working day of the reasons for its action.’;
O razlogih za tako ukrepanje Komisija obvesti Agencijo in države članice najpozneje naslednji delovni dan.";
in Article 34(3), the following subparagraph is added:
v členu 34(3) se doda naslednji pododstavek:
‘Where the scope of the procedure initiated under Article 31 includes medicinal products authorised in accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of Article 31(2) of this Directive, the Commission shall, where necessary, adopt decisions to vary, suspend or revoke the marketing authorisations or to refuse the renewal of the marketing authorisations concerned.’;
"Kadar področje uporabe postopka, začetega na podlagi člena 31, vključuje zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004 v skladu s tretjim pododstavkom člena 31(2) te direktive, Komisija po potrebi sprejme sklepe za spremembo, začasni odvzem ali ukinitev zadevnih dovoljenj za promet ali za zavrnitev podaljšanja zadevnih dovoljenj za promet.";
in Article 37, the words ‘Articles 35 and 36 shall apply’ are replaced by the words ‘Article 35 shall apply’;
v členu 37 se besede "Člena 35 in 36 se smiselno uporabljata" nadomestijo z besedami "Člen 35 se smiselno uporablja";
The particulars for labelling listed in Articles 54, 59 and 62 shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.’;
Podrobni podatki za označevanje iz členov 54, 59 in 62 so napisani v uradnem jeziku ali uradnih jezikih države članice, kjer je zdravilo v prometu, kakor za namene te direktive določa navedena država članica.";
The package leaflet must be written and designed in such a way as to be clear and understandable, enabling users to act appropriately, when necessary with the help of health professionals.
Navodilo za uporabo mora biti napisano in oblikovano na jasen ter razumljiv način, ki uporabnikom omogoča pravilno ravnanje, če je potrebno tudi s pomočjo zdravstvenega osebja.
The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.’;
Navodilo za uporabo mora biti jasno berljivo v uradnem jeziku ali uradnih jezikih države članice, kjer je zdravilo v prometu, kakor za namene te direktive določa navedena država članica.";
Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet.
Kadar zdravilo ni namenjeno neposredni dobavi bolniku ali kadar obstajajo resne težave v zvezi z dostopnostjo zdravila, lahko pristojni organi ob upoštevanju ukrepov, za katere menijo, da so potrebni za varovanje zdravja ljudi, odobrijo izjemo od obveznosti, v skladu s katero bi morali biti na ovojnini in v navodilu za uporabo navedeni nekateri podrobni podatki.
They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.’;
Odobrijo lahko tudi celotno ali delno izjemo od obveznosti, da morata biti ovojnina in navodilo za uporabo v uradnem jeziku ali uradnih jezikih države članice, kjer je zdravilo v prometu, kakor za namene te direktive določa ta država članica.";
Article 85a is replaced by the following:
člen 85a se nadomesti z naslednjim:
‘Article 85a
"Člen 85a
In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of the first paragraph of Article 80 shall not apply.
Za promet z zdravili na debelo v tretje države se ne uporabljata člen 76 in točka (c) prvega odstavka člena 80.
Moreover, points (b) and (ca) of the first paragraph of Article 80 shall not apply where a product is directly received from a third country but not imported.
Poleg tega se ne uporabljata točki (b) in (ca) prvega odstavka člena 80, kadar se izdelek prejme neposredno iz tretje države, vendar se ne uvozi.
However, in that case wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned.
Vendar v tem primeru trgovci na debelo zagotovijo, da zdravila pridobijo samo od oseb, ki imajo dovoljenje ali so pooblaščene za dobavljanje zdravil v skladu z veljavnimi pravnimi in upravnimi določbami zadevne tretje države.
Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned.
Če trgovci na debelo zdravila dobavljajo osebam tretjih držav, zagotovijo, da jih dobavljajo samo osebam, ki imajo dovoljenje ali so pooblaščene za prejemanje zdravil za namen prodaje na debelo ali izdajanja zdravil javnosti v skladu z veljavnimi pravnimi in upravnimi določbami zadevne tretje države.
The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.’;
Zahteve iz člena 82 se uporabljajo za dobavo zdravil osebam v tretjih državah, ki imajo dovoljenje ali pravico do izdajanja zdravil javnosti.";
in Article 107i, paragraph 1 is replaced by the following:
v členu 107i se odstavek 1 nadomesti z naslednjim:
A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, initiate the procedure provided for in this section by informing the other Member States, the Agency and the Commission where:
Država članica ali Komisija, kakor je ustrezno, na osnovi zadržkov, ki izhajajo iz ocene podatkov, pridobljenih iz dejavnosti farmakovigilance, začne postopek iz tega oddelka tako, da druge države članice, Agencijo in Komisijo obvesti, kadar:
it considers suspending or revoking a marketing authorisation;
obravnava možnost začasnega odvzema ali ukinitve dovoljenja za promet;
it considers refusing the renewal of a marketing authorisation; or
obravnava možnost zavrnitve podaljšanja dovoljenja za promet; ali
it is informed by the marketing authorisation holder that, on the basis of safety concerns, the holder has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or intends to take such action or has not applied for the renewal of a marketing authorisation.
jo imetnik dovoljenja za promet obvesti, da je imetnik dovoljenja zaradi varnostnih zadržkov prekinil dajanje zdravila v promet ali ukrepal za umik dovoljenja za promet ali to namerava storiti ali pa ni zaprosil za podaljšanje dovoljenja za promet.
A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, inform the other Member States, the Agency and the Commission where it considers that a new contraindication, a reduction in the recommended dose or a restriction to the indications of a medicinal product is necessary.
Država članica ali Komisija, kakor je ustrezno, na osnovi zadržkov, ki izhajajo iz ocene podatkov, pridobljenih iz dejavnosti farmakovigilance, obvesti druge države članice, Agencijo in Komisijo, kadar meni, da so potrebne nove kontraindikacije, zmanjšanje priporočenega odmerka ali omejitev indikacij zdravila.
The information shall outline the action considered and the reasons therefor.
V obvestilu so opisani obravnavani ukrepi in razlogi zanje.
Any Member State or the Commission, as appropriate, shall, when urgent action is considered necessary, initiate the procedure provided for in this section in any of the cases referred to in this paragraph.
Vsaka država članica ali Komisija, kakor je ustrezno, v katerem koli od primerov iz tega odstavka začne postopek iz tega oddelka, ko meni, da so potrebni nujni ukrepi.
Where the procedure provided for in this section is not initiated, for medicinal products authorised in accordance with the procedures laid down in Chapter 4 of Title III, the case shall be brought to the attention of the coordination group.
Če postopek iz tega oddelka ni začet, se v primeru, ko so zdravila odobrena v skladu s postopki iz poglavja 4 naslova III, zadeva posreduje skupini za usklajevanje.
Article 31 shall be applicable where the interests of the Union are involved.
Člen 31 se uporabi, kadar so vključeni interesi Unije.
Where the procedure provided for in this section is initiated, the Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class.
Če je postopek iz tega oddelka začet, Agencija preveri, ali je varnostni zadržek povezan z drugimi zdravili, ki niso zajeta v obvestilu, in ali je skupen vsem zdravilom, ki pripadajo istemu nizu ali terapevtski skupini.
Otherwise, the safety concern shall be addressed by the Member State concerned.
Sicer pa varnostni zadržek obravnava zadevna država članica.
The Agency or the Member State, as applicable, shall make the information that the procedure has been initiated available to marketing authorisation holders.’;
Agencija ali država članica, kakor je primerno, obvesti imetnike dovoljenja za promet o začetku postopka.";
in Article 107i(2) the words ‘paragraph 1 of this Article’ are replaced by the words ‘paragraphs 1 and 1a of this Article’;
v členu 107i(2) se besede "odstavka 1 tega člena" nadomestijo z besedami "odstavkov 1 in 1a tega člena";
in the second subparagraph of Article 107i(3) the words ‘in accordance with paragraph 1’ are replaced by the words ‘in accordance with paragraphs 1 and 1a’;
v drugem pododstavku člena 107i(3) se besede "v skladu z odstavkom 1" nadomestijo z besedami "v skladu z odstavkoma 1 in 1a";
in Article 107i(5) the words ‘in paragraph 1’ are replaced by the words ‘in paragraphs 1 and 1a’;
v členu 107i(5) se besede "iz odstavka 1" nadomestijo z besedami "iz odstavkov 1 in 1a";
in the first subparagraph of Article 107j(1) the words ‘in Article 107i(1)’ are replaced by the words ‘in paragraphs 1 and 1a of Article 107i’;
v prvem pododstavku člena 107j(1) se besede "iz člena 107i(1)" nadomestijo z besedami "iz odstavkov 1 in 1a člena 107i";
Article 123 is amended as follows:
člen 123 se spremeni:
The marketing authorisation holder shall be obliged to notify the Member States concerned forthwith of any action taken by the holder to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action.
Imetnik dovoljenja za promet je dolžan zadevne države članice takoj obvestiti o vseh ukrepih, ki jih je sprejel za začasen umik zdravila iz prometa, umik zdravila iz prometa, za zahtevo za umik dovoljenja za promet ali za nepodaljšanje dovoljenja za promet, skupaj z razlogi za tako ukrepanje.
The marketing authorisation holder shall in particular declare if such action is based on any of the grounds set out in Article 116 or Article 117(1).
Imetnik dovoljenja za promet zlasti navede, ali tako ukrepanje temelji na katerem koli od razlogov iz člena 116 ali člena 117(1).
The marketing authorisation holder shall also make the notification pursuant to paragraph 2 of this Article in cases where the action is taken in a third country and where such action is based on any of the grounds set out in Article 116 or Article 117(1).
Imetnik dovoljenja za promet pošlje obvestilo v skladu z odstavkom 2 tega člena tudi, kadar ukrepa v tretji državi in kadar ukrep temelji na razlogih iz člena 116 ali člena 117(1).
The marketing authorisation holder shall furthermore notify the Agency where the action referred to in paragraph 2 or 2a of this Article is based on any of the grounds referred to in Article 116 or Article 117(1).
Imetnik dovoljenja za promet poleg tega obvesti Agencijo, kadar ukrep iz odstavka 2 ali 2a tega člena temelji na katerem koli od razlogov iz člena 116 ali člena 117(1).
The Agency shall forward notifications received in accordance with paragraph 2b to all Member States without undue delay.’;
Agencija v skladu z odstavkom 2b informacije nemudoma posreduje vsem državam članicam.";