02006R1920 — GA — 23.11.2018 — 001.002

Is áis doiciméadúcháin amháin an téacs seo agus níl aon éifeacht dhlíthiúil aige. Ní ghabhann institiúidí an Aontais aon dliteanas orthu féin i leith inneachar an téacs. Is iad na leaganacha de na gníomhartha a foilsíodh in Iris Oifigiúil an Aontais Eorpaigh agus atá ar fáil ar an suíomh gréasáin EUR-Lex na leaganacha barántúla de na gníomhartha ábhartha, brollach an téacs san áireamh. Is féidir teacht ar na téacsanna oifigiúla sin ach na naisc atá leabaithe sa doiciméad seo a bhrú

►B REGULATION (EC) No 1920/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast) (IO L 376 27.12.2006, lch. 1)

Arna leasú le:









▼B

REGULATION (EC) No 1920/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 December 2006

on the European Monitoring Centre for Drugs and Drug Addiction (recast)







Article 1

Objective

1. This Regulation provides for the European Monitoring Centre for Drugs and Drug Addiction (‘the Centre’).

2. The Centre's objective is to provide, in the areas referred to in Article 3, the Community and its Member States with factual, objective, reliable and comparable information at European level concerning drugs and drug addiction and their consequences.

3. The statistical, documentary and technical information processed or produced is intended to help provide the Community and the Member States with an overall view of the drug and drug addiction situation when, in their respective areas of competence, they take measures or decide on action. The statistical element of this information shall be developed, in collaboration with the relevant statistical authorities, using as necessary the Community Statistical Programme to promote synergy and avoid duplication. Account shall be taken of further data from the World Health Organisation and the United Nations Organisation (the ‘UN’) available worldwide.

4. Without prejudice to Article 2(d)(v), the Centre may not take any measure which goes beyond the sphere of information and the processing thereof.

5. The Centre shall not collect any data making it possible to identify individuals or small groups of individuals. It shall refrain from any transmission of information relating to specific named cases.

Article 2

Tasks

In order to achieve the objective set out in Article 1, the Centre shall perform the following tasks within its areas of activity:

(a) Collection and analysis of existing data (i) collecting, registering and analysing information, including data resulting from research, communicated by Member States and data emanating from Community, non-governmental national sources and competent international organisations, including the European Police Office (Europol); providing information on best practices in the Member States and facilitating the exchange of such practices among them; this collection, registration, analysis and information work shall also cover data on emerging trends in poly-drug use, including the combined use of licit and illicit psychoactive substances; (ii) carrying out surveys, preparatory studies and feasibility studies, together with any pilot projects necessary to accomplish its tasks; organising meetings of experts and, whenever necessary, setting up ad hoc working parties for the purpose; setting up and making available open scientific documentation resources and assisting in the promotion of information activities; (iii) providing an organisational and technical system capable of supplying information on similar or complementary programmes or action pursued by the Member States; (iv) establishing and coordinating, in consultation and in cooperation with the competent authorities and organisations in the Member States, the network referred to in Article 5; (v) facilitating exchanges of information between decision-makers, researchers, specialists and those involved in drugs-related issues in governmental and non-governmental organisations;

(b) Improvement of data-comparison methods (i) ensuring improved comparability, objectivity and reliability of data at European level by establishing indicators and common criteria of a non-binding nature, compliance with which may be recommended by the Centre, with a view to ensuring greater uniformity of the measurement methods used by the Member States and the Community; in particular, the Centre shall develop tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate Union policies; (ii) facilitating and structuring information exchange in terms of both quality and quantity (databases);

(c) Dissemination of data (i) making the information produced by it available to the Community, the Member States and competent organisations; (ii) ensuring wide dissemination of work done in each Member State and by the Community itself, and, where appropriate, by third countries or international organisations; (iii) ensuring wide dissemination of reliable non-confidential data, publishing on the basis of data which it gathers, a yearly report on the state of the drugs problem, including data on emerging trends;

(d) Cooperation with European and international bodies and organisations and with third countries (i) contributing to improving coordination between national and Community action in its areas of activity; (ii) without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Conventions on drugs, promoting the incorporation of data on drugs and drug addiction gathered in the Member States or emanating from the Community into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies; (iii) cooperating actively with Europol to attain maximum efficiency in monitoring the drugs problem; (iv) cooperating actively with the organisations and bodies referred to in Article 20; (v) transferring, at the request of the Commission and with the approval of the Management Board referred to in Article 9, its know-how to certain third countries such as candidate countries or the countries of the western Balkans and assist in the creation and strengthening of structural links with the network referred to in Article 5 and the setting-up and consolidation of the national focal points referred to in that Article;

(e) Information obligations In principle, the Centre shall, if it identifies new developments and changing trends, inform the competent authorities of the Member States thereof;

▼M1

(f) Malartú faisnéise maidir le substaintí sícighníomhacha nua, córas luathrabhaidh maidir leo, agus measúnú riosca orthu (i) an fhaisnéis atá ar fáil ó na pointí comhtheagmhála náisiúnta dá dtagraítear in Airteagal 5 agus ó aonaid náisiúnta Europol maidir le substaintí sícighníomhacha nua mar a shainmhínítear iad i bpointe 4 d'Airteagal 1 de Chinneadh Réime 2004/757/CGB ón gComhairle ( 1 ) a bhailiú, a chomhthiomsú, a anailísiú agus a mheasúnú, agus an fhaisnéis sin a chur in iúl do na pointí comhtheagmhála náisiúnta, d'aonaid náisiúnta Europol agus don Choimisiún gan mhoill mhíchuí; (ii) an tuarascáil tosaigh nó an tuarascáil chomhcheangailte tosaigh a tharraingt suas i gcomhréir le hAirteagal 5b; (iii) an nós imeachta measúnaithe riosca a eagrú i gcomhréir le hAirteagal 5c agus le hAirteagal 5d; (iv) faireachán a dhéanamh, i gcomhar le Europol agus le tacaíocht ó na pointí comhtheagmhála náisiúnta dá dtagraítear in Airteagal 5 agus ó aonaid náisiúnta Europol, ar gach substaint shícighníomhach nua atá tuairiscithe ag na Ballstáit.

▼B

Article 3

Priority areas of activity

The objective and tasks of the Centre, as set out in Articles 1 and 2, shall be implemented following the order of priorities indicated in Annex I.

Article 4

Working method

1. The Centre shall progressively carry out its tasks in the light of the objectives adopted in the three-year and annual work programmes referred to in Article 9(4) and (5) and with due regard to the available resources.

2. In pursuing its activities, the Centre shall, in order to avoid duplication, take account of activities already carried out by other existing or future institutions and agencies, notably Europol, and shall ensure that it adds to their value.

Article 5

European Information Network on Drugs and Drug Addiction (Reitox)

1. The Centre shall have at its disposal the European Information Network on Drugs and Drug Addiction (Reitox). The network shall consist of one focal point for each Member State and each country which has concluded an agreement pursuant to Article 21 and a focal point for the Commission. The designation of the national focal points shall be the exclusive responsibility of the countries concerned.

2. The national focal points shall form an interface between the participating countries and the Centre. They shall contribute to the establishment of key indicators and data, including guidelines for their implementation with a view to obtaining reliable and comparable information at European Union level. They shall collect and analyse in an objective manner at national level, bringing together experience from different sectors – health, justice, law enforcement – in cooperation with experts and national organisations active in the field of drugs policy, all relevant information on drugs and drug addiction, as well as on policies and solutions applied. In particular, they shall provide data for the five epidemiological indicators specified by the Centre. ▼M1 ————— ▼B The national focal points may also provide the Centre with information on new trends in the use of existing psychoactive substances and/or new combinations of psychoactive substances which pose a potential risk to public health as well as information on possible measures related to public health.

3. The national authorities shall ensure the operation of their focal point for the collection and analysis of data at national level on the basis of guidelines adopted with the Centre.

4. The specific tasks allocated to the national focal points shall appear in the Centre's three-year programme as referred to in Article 9(4).

5. While fully respecting the primacy of the national focal points, and in close cooperation with them, the Centre may have recourse to additional expertise and sources of information in the field of drugs and drug addiction.

▼M1

Airteagal 5a

Malartú faisnéise maidir le substaintí sícighníomhacha nua, agus córas luathrabhaidh maidir leo

Áiritheoidh gach Ballstát go ndéanfaidh a phointe comhtheagmhála náisiúnta, faoi mar a thagraítear dó in Airteagal 5, agus a aonad náisiúnta Europol an fhaisnéis atá ar fáil maidir le substaintí sícighníomhacha nua a sholáthar don Lárionad agus do Europol, agus a sainorduithe faoi seach á gcur san áireamh, ar bhealach tráthúil agus gan mhoill mhíchuí. Bainfidh an fhaisnéis le brath agus le sainaithint na substaintí sin, lena n-úsáid agus le patrúin a n-úsáide, lena monarú, lena n-eastóscadh, lena ndáileadh agus lena modhanna dáilte, lena ngáinneáil, lena n-úsáid tráchtála, mhíochaine agus eolaíoch, agus leis na rioscaí féideartha agus sainaitheanta a ghabhann leis na substaintí sin.

Déanfaidh an Lárionad, i gcomhar le Europol, an fhaisnéis a bhailiú, a chomhthiomsú, a anailísiú agus a mheasúnú agus cuirfidh sé in iúl í ar bhealach tráthúil don phointe comhtheagmhála náisiúnta, d'aonaid náisiúnta Europol agus don Choimisiún d'fhonn aon fhaisnéis a sholáthar dóibh a cheanglaítear chun críocha luathrabhaidh agus chun ligean don Lárionad an tuarascáil tosaigh nó an tuarascáil chomhcheangailte tosaigh a tharraingt suas de bhun Airteagal 5b.

Airteagal 5b

Tuarascáil tosaigh

1. I gcás ina measann an Lárionad, an Coimisiún nó tromlach de na Ballstáit go bhfuil ábhar imní ann, mar gheall ar an bhfaisnéis a comhroinneadh ar shubstaint shícighníomhach nua a bailíodh de bhun Airteagal 5a i mBallstát amháin nó níos mó, go bhféadfaidh rioscaí don tsláinte nó rioscaí sóisialta a bheith ag gabháil leis an tsubstaint shícighníomhach nua ar leibhéal an Aontais, déanfaidh an Lárionad tuarascáil tosaigh a tharraingt suas ar an tsubstaint shícighníomhach nua.

Chun críche na míre seo, cuirfidh na Ballstáit an Coimisiún agus na Ballstáit eile ar an eolas maidir lena mian go ndéanfaí tuarascáil tosaigh a tharraingt suas. Ar shroicheadh thromlach na mBallstát, tabharfaidh an Coimisiún treoir don Lárionad dá réir agus cuirfidh sé na Ballstáit ar an eolas ina leith.

2. Sa tuarascáil tosaigh beidh céadléiriú ar an méid seo a leanas: (a) cineál, líon agus scála na dteagmhas a léiríonn fadhbanna sláinte agus sóisialta ina bhféadfadh an tsubstaint shícighníomhach a bheith i gceist, agus patrúin úsáide na substainte sícighníomhaí nua; (b) cur síos ceimiceach agus fisiceach ar an tsubstaint shícighníomhach nua agus na modhanna agus na réamhtheachtaithe a úsáidtear lena monarú nó lena heastóscadh; (c) cur síos cógaseolaíoch agus tocsaineolaíoch ar an tsubstaint shícighníomhach nua; (d) rannpháirtíocht grúpaí coiriúla i monarú nó i ndáileadh na substainte sícighníomhaí nua. Beidh an fhaisnéis seo a leanas sa tuarascáil tosaigh freisin: (a) faisnéis maidir le húsáid mhíochaine na substainte sícighníomhaí nua sa duine agus sa tréidliacht, lena n-áirítear a húsáid mar shubstaint ghníomhach i dtáirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta; (b) faisnéis maidir le húsáid tráchtála agus thionsclaíoch na substainte sícighníomhaí nua, ar mhéid na húsáide sin, agus ar úsáid na substainte ar mhaithe le taighde eolaíoch agus forbairt eolaíoch; (c) faisnéis i dtaobh cé acu atá nó nach bhfuil an tsubstaint shícighníomhach nua faoi réir aon bhearta sriantacha sna Ballstáit; (d) faisnéis i dtaobh cé acu atá nó nach bhfuil an tsubstaint shícighníomhach nua á measúnú faoi láthair, nó an raibh sí á measúnú, laistigh den chóras a bunaíodh le Coinbhinsiún Aonair um Dhrugaí Támhshuanacha 1961, arna leasú le Prótacal 1972, agus le Coinbhinsiún maidir le Substaintí Síceatrópacha 1971 (‘córas na Náisiún Aontaithe’). (e) faisnéis ábhartha eile, i gcás ina bhfuil sí ar fáil.

3. Chun críche na tuarascála tosaigh, úsáidfidh an Lárionad faisnéis atá ar fáil dó.

4. I gcás ina measann an Lárionad gur gá déanamh amhlaidh, iarrfaidh sé ar na pointí comhtheagmhála náisiúnta dá dtagraítear in Airteagal 5 faisnéis bhreise a sholáthar maidir leis an tsubstaint shícighníomhach nua. Soláthróidh na pointí comhtheagmhála náisiúnta an fhaisnéis sin laistigh de 2 sheachtain tar éis dóibh an iarraidh a fháil.

5. Iarrfaidh an Lárionad, gan moill mhíchuí, ar an nGníomhaireacht Leigheasra Eorpach faisnéis a sholáthar i dtaobh cé acu atá nó nach bhfuil, ar leibhéal an Aontais nó ar an leibhéal náisiúnta, an tsubstaint shícighníomhach nua ina substaint ghníomhach i gceann amháin de na nithe seo a leanas: (a) táirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta a bhfuil údarú margaíochta faighte aige i gcomhréir le Treoir 2001/83/CE ó Pharlaimint na hEorpa agus ón gComhairle ( 2 ), Treoir 2001/82/CE ó Pharlaimint na hEorpa agus ón gComhairle ( 3 ) nó Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle ( 4 ); (b) táirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta atá ina ábhar d'iarratas ar údarú margaíochta; (c) táirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta a bhfuil a údarú margaíochta curtha ar fionraí ag an údarás inniúil; (d) táirge neamhúdaraithe íocshláinte lena úsáid ag an duine i gcomhréir le hAirteagal 5 de Threoir 2001/83/CE nó i dtáirge íocshláinte tréidliachta arna ullmhú ar an toirt ag duine ar tugadh údarú dó nó di déanamh amhlaidh faoin dlí náisiúnta i gcomhréir le pointe (c) d'Airteagal 10(1) de Threoir 2001/82/CE; (e) táirge íocshláinte imscrúdaitheach mar a shainmhínítear é i bpointe (d) d'Airteagal 2 de Threoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle ( 5 ).

I gcás ina mbaineann an fhaisnéis le húdaruithe margaíochta arna ndeonú ag na Ballstáit, cuirfidh na Ballstáit lena mbaineann faisnéis den sórt sin ar fáil don Ghníomhaireacht Leigheasra Eorpach arna iarraidh sin di.

6. Iarrfaidh an Lárionad, gan mhoill mhíchuí, ar Europol faisnéis a sholáthar maidir le rannpháirtíocht grúpaí coiriúla i monarú, i ndáileadh agus i modhanna dáilte, agus i ngáinneáil na substainte sícighníomhaí nua, agus in aon úsáid a bhaintear as an tsubstaint shícighníomhach nua.

7. Iarrfaidh an Lárionad, gan mhoill mhíchuí, ar an nGníomhaireacht Eorpach Ceimiceán, ar an Lárionad Eorpach um Ghalair a Chosc agus a Rialú agus ar an Údarás Eorpach um Shábháilteacht Bia an fhaisnéis agus na sonraí atá ar fáil acu ar an tsubstaint shícighníomhach nua a sholáthar dó.

8. Is le socruithe oibre a rialófar sonraí an chomhair idir an Lárionad agus na comhlachtaí agus na gníomhaireachtaí dá dtagraítear i mír 5, i mír 6 agus i mír 7 den Airteagal seo. Tabharfar socruithe oibre den sórt sin i gcrích i gcomhréir leis an dara mír d'Airteagal 20.

9. Urramóidh an Lárionad na coinníollacha maidir le húsáid na faisnéise, ar coinníollacha iad a chuirfear in iúl don Lárionad, lena n-áirítear coinníollacha maidir le rochtain ar dhoiciméid, maidir le slándáil faisnéise agus sonraí agus cosaint sonraí rúnda, lena n-áirítear sonraí íogaire agus faisnéis rúnda ghnó.

10. Cuirfidh an Lárionad an tuarascáil tosaigh faoi bhráid an Choimisiúin agus na mBallstát laistigh de chúig seachtaine ó na hiarrataí ar fhaisnéis dá dtagraítear i mír 5, i mír 6 agus i mír 7 a dhéanamh.

11. I gcás ina mbailíonn an Lárionad faisnéis maidir le roinnt substaintí sícighníomhacha nua a measann sé go bhfuil struchtúr ceimiceach comhchosúil acu, cuirfidh sé faoi bhráid an Choimisiúin agus na mBallstát tuarascálacha tosaigh aonair, nó tuarascálacha comhcheangailte tosaigh ina mbeidh trácht ar roinnt substaintí sícighníomhacha nua, ar choinníoll go mbeidh saintréithe gach substainte sícighníomhaí nua sainaitheanta go soiléir, agus déanfaidh sé amhlaidh laistigh de 6 seachtaine ó na hiarrataí ar fhaisnéis dá dtagraítear i mír 5, i mír 6 agus i mír 7 a dhéanamh.

Airteagal 5c

An nós imeachta measúnaithe riosca agus an tuarascáil ar an measúnú riosca

1. Laistigh de 2 sheachtain ó thuarascáil tosaigh dá dtagraítear in Airteagal 5b(10) a fháil, féadfaidh an Coimisiún iarraidh ar an Lárionad measúnú a dhéanamh ar na rioscaí a d'fhéadfadh a bheith ag gabháil leis an tsubstaint shícighníomhach nua agus tuarascáil ar an measúnú riosca a tharraingt suas ina leith, i gcás ina léirítear sa tuarascáil tosaigh creidiúintí go bhféadfaidh rioscaí tromchúiseacha don tsláinte phoiblí agus, i gcás inarb infheidhme, rioscaí tromchúiseacha sóisialta, a bheith ag gabháil leis an tsubstaint sin. Is é an Coiste Eolaíochta a dhéanfaidh an measúnú riosca.

2. Laistigh de 2 sheachtain ó thuarascáil chomhcheangailte tosaigh dá dtagraítear in Airteagal 5b(11) a fháil, féadfaidh an Coimisiún iarraidh ar an Lárionad measúnú a dhéanamh ar na rioscaí a d'fhéadfadh a bheith ag gabháil le roinnt substaintí sícighníomhacha nua a bhfuil struchtúr ceimiceach comhchosúil acu agus tuarascáil ar an measúnú comhcheangailte riosca a tharraingt suas ina leith, i gcás ina léirítear sa tuarascáil chomhcheangailte tosaigh go bhféadfaidh rioscaí tromchúiseacha don tsláinte phoiblí agus, i gcás inarb infheidhme, rioscaí tromchúiseacha sóisialta, a bheith ag gabháil leis na substaintí. Is é an Coiste Eolaíochta a dhéanfaidh an measúnú comhcheangailte riosca.

3. Beidh an méid seo a leanas sa tuarascáil ar an measúnú riosca nó sa tuarascáil ar an measúnú comhcheangailte riosca: (a) an fhaisnéis atá ar fáil maidir le hairíonna ceimiceacha agus fisiceacha na substainte sícighníomhaí nua agus leis na modhanna agus leis na réamhtheachtaithe a úsáidtear lena monarú nó lena heastóscadh; (b) an fhaisnéis atá ar fáil maidir le hairíonna cógaseolaíocha agus tocsaineolaíocha na substainte sícighníomhaí nua; (c) anailís ar na rioscaí sláinte a bhaineann leis an tsubstaint shícighníomhach nua, go háirithe maidir lena géarthocsaineacht agus lena tocsaineacht ainsealach, leis an dóchúlacht go mbainfear mí-úsáid aisti, leis an acmhainneacht go n-éireoidh duine spleách uirthi, agus leis na héifeachtaí féideartha fisiceacha, meabhracha agus iompraíochta atá aici; (d) anailís ar na rioscaí sóisialta a ghabhann leis an tsubstaint shícighníomhach nua — go háirithe a tionchar ar fheidhmiú sóisialta, ar an ord poiblí agus ar ghníomhaíochtaí coiriúla, agus rannpháirtíocht grúpaí coiriúla i monarú, i ndáileadh agus i modhanna dáilte, agus i ngáinneáil na substainte sícighníomhaí nua; (e) an fhaisnéis atá ar fáil maidir le méid agus patrúin úsáide na substainte sícighníomhaí nua, leis an bhfáil atá uirthi agus leis an bhféidearthacht go scaipfear í laistigh den Aontas; (f) an fhaisnéis atá ar fáil maidir le húsáid tráchtála agus thionsclaíoch na substainte sícighníomhaí nua, le méid na húsáide sin, agus le húsáid na substainte ar mhaithe le taighde eolaíoch agus forbairt eolaíoch. (g) faisnéis ábhartha eile, i gcás ina bhfuil sí ar fáil.

4. Déanfaidh an Coiste Eolaíochta measúnú ar na rioscaí a ghabhann leis an tsubstaint shícighníomhach nua nó leis an ngrúpa substaintí sícighníomhacha nua. Féadfaidh an Stiúrthóir an Coiste Eolaíochta a leathnú, ag gníomhú dó ar bhonn comhairle ó chathaoirleach an Choiste Eolaíochta, a mhéid a mheasann sé a bheith riachtanach, trí shaineolaithe a chur leis atá ionadaíoch do na réimsí eolaíochta is ábhartha chun a áirithiú go ndéanfar measúnú cothrom ar na rioscaí a ghabhann leis an tsubstaint shícighníomhach nua. Déanfaidh an Stiúrthóir na saineolaithe sin a cheapadh as liosta saineolaithe. Formheasfaidh an Bord Bainistíochta an liosta saineolaithe gach 3 bliana.

Beidh sé de cheart ag an gCoimisiún, ag an Lárionad, ag Europol agus ag an nGníomhaireacht Leigheasra Eorpach 2 bhreathnóir an ceann a ainmniú.

5. Déanfaidh an Coiste Eolaíochta an measúnú riosca ar bhonn na faisnéise atá ar fáil agus ar bhonn aon fhianaise eolaíche ábhartha eile. Cuirfidh sé tuairimí uile chomhaltaí a choiste san áireamh. Eagróidh an Lárionad an nós imeachta measúnaithe riosca, lena n-áirítear riachtanais thodhchaíocha faisnéise agus staidéir thodhchaíocha ábhartha a shainaithint.

6. Cuirfidh an Lárionad an tuarascáil ar an measúnú riosca nó an tuarascáil ar an measúnú comhcheangailte riosca faoi bhráid an Choimisiúin agus na mBallstát laistigh de 6 seachtaine ón iarraidh a fháil ón gCoimisiún tuarascáil ar an measúnú riosca a tharraingt suas.

7. Ar iarraidh chuí-réasúnaithe ón Lárionad a fháil dó, féadfaidh an Coimisiún síneadh a chur leis an tréimhse ar lena linn atá an measúnú riosca nó an measúnú comhcheangailte riosca le críochnú ar mhaithe le taighde breise agus bailiú sonraí breise a cheadú. Beidh faisnéis maidir leis an tréimhse ama a theastaíonn chun an measúnú riosca nó an measúnú comhcheangailte riosca a chríochnú san iarraidh sin.

Airteagal 5d

Eisiamh ón measúnú riosca

1. Ní dhéanfar aon mheasúnú riosca sa chás go bhfuil céim i bhfad amach sroichte sa mheasúnú ar an tsubstaint shícighníomhach nua laistigh de chóras na Náisiún Aontaithe, eadhon a luaithe a bheidh Coiste Saineolaithe na hEagraíochta Domhanda Sláinte ar Spleáchas ar Dhrugaí tar éis a athbhreithniú criticiúil, mar aon le moladh i scríbhinn, a fhoilsiú, ach amháin sa chás go bhfuil sonraí leordhóthanacha agus faisnéis leordhóthanach ann chun a thabhairt le tuiscint go bhfuil gá le tuarascáil ar an measúnú riosca ar leibhéal an Aontais, a luafar na cúiseanna atá léi sa tuarascáil tosaigh.

2. Ní dhéanfar aon mheasúnú riosca i gcás inarb amhlaidh, tar éis measúnú laistigh de chóras na Náisiún Aontaithe, gur cinneadh gan an tsubstaint shícighníomhach nua a sceidealú faoi Choinbhinsiún Aonair um Dhrugaí Támhshuanacha 1961, arna leasú le Prótacal 1972, nó faoi Choinbhinsiún maidir le Substaintí Síceatrópacha 1971, ach amháin sa chás go bhfuil sonraí leordhóthanacha agus faisnéis leordhóthanach ann chun a thabhairt le tuiscint go bhfuil gá le tuarascáil ar an measúnú riosca ar leibhéal an Aontais, a luafar na cúiseanna atá léi sa tuarascáil tosaigh.

3. Ní dhéanfar aon mheasúnú riosca sa chás go bhfuil an tsubstaint shícighníomhach nua ina substaint ghníomhach i gceann amháin de na nithe seo a leanas: (a) táirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta a bhfuil údarú margaíochta faighte aige; (b) táirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta atá ina ábhar d'iarratas ar údarú margaíochta; (c) táirge íocshláinte lena úsáid ag an duine nó i dtáirge íocshláinte tréidliachta a bhfuil a údarú margaíochta curtha ar fionraí ag an údarás inniúil; (d) táirge íocshláinte imscrúdaitheach mar a shainmhínítear é i bpointe (d) d'Airteagal 2 de Threoir 2001/20/CE.

▼B

Article 6

Protection and confidentiality of data

1. Data on drugs and drug addiction provided to or by the Centre may be published subject to compliance with Community and national rules on the dissemination and confidentiality of information. Personal data may not be published or made accessible to the public. Member States and the national focal points shall be under no obligation to provide information classified as confidential under their national law.

2. Regulation (EC) No 45/2001 shall apply to the Centre.

Article 7

Access to documents

1. Regulation (EC) No 1049/2001 shall apply to documents held by the Centre.

2. The Management Board referred to in Article 9 shall adopt the arrangements for implementing Regulation (EC) No 1049/2001.

3. Decisions taken by the Centre pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to the lodging of a complaint to the Ombudsman or form the subject of an action before the Court of Justice of the European Communities, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.

Article 8

Legal capacity and location

1. The Centre shall have legal personality. In each of the Member States, it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings.

2. The seat of the Centre shall be located in Lisbon.

Article 9

Management Board

1. The Centre shall have a Management Board consisting of one representative from each Member State, two representatives from the Commission, two independent experts particularly knowledgeable in the field of drugs designated by the European Parliament and one representative from each country which has concluded an agreement pursuant to Article 21. Each member of the Management Board shall have one vote, except for the representatives of the countries which have concluded agreements pursuant to Article 21, who shall not have the right to vote. The decisions of the Management Board shall be taken by a two-thirds majority of the members with a right to vote, except in the cases provided for in paragraph 6 of this Article and in Article 20. Each member of the Management Board may be assisted or represented by a substitute. Where a full member who has the right to vote is absent, his or her substitute may exercise that right. The Management Board may invite as non-voting observers representatives of international organisations with which the Centre cooperates in accordance with Article 20.

2. The Chairperson and Vice-Chairperson of the Management Board shall be elected from amongst and by its members for a three-year period. Their terms of office shall be renewable once. The Chairperson and Vice-Chairperson shall have the right to take part in the voting. The Management Board shall draw up its own rules of procedure.

3. The meetings of the Management Board shall be convened by its Chairperson. It shall hold an ordinary meeting at least once a year. The Centre's Director, as referred to in Article 11, shall take part in the meetings of the Management Board, without voting rights, and shall, under Article 11(3), provide for the Board's Secretariat.

4. The Management Board shall adopt a three-year work programme on the basis of a draft submitted by the Director, after consulting the Scientific Committee referred to in Article 13 and obtaining the opinion of the Commission, and shall forward it to the European Parliament, the Council and the Commission.

5. Under the three-year work programme, the Management Board shall adopt each year the Centre's annual work programme on the basis of a draft submitted by the Director, after consulting the Scientific Committee and obtaining the opinion of the Commission. The work programme shall be forwarded to the European Parliament, the Council and the Commission. It may be adjusted in the course of the year in accordance with the same procedure.

6. Where the Commission expresses its disagreement with the three-year or annual work programme, those programmes shall be adopted by the Management Board by a three-fourths majority of the members with a right to vote.

7. The Management Board shall adopt the annual report on the Centre's activities and forward it by 15 June to the European Parliament, the Council, the Commission, the Court of Auditors and the Member States.

8. The Centre shall forward annually to the budgetary authority any information relevant to the outcome of the evaluation procedures.

Article 10

Executive Committee

1. The Management Board shall be assisted by an Executive Committee. The Executive Committee shall be made up of the Chairperson and the Vice-Chairperson of the Management Board, two other members of the Management Board representing the Member States and appointed by the Management Board and two Commission representatives. The Director shall take part in meetings of the Executive Committee.

2. The Executive Committee shall meet at least twice a year and whenever necessary to prepare the decisions of the Management Board and to assist and advise the Director. It shall decide on behalf of the Management Board on those matters provided for in the financial rules adopted pursuant to Article 15(10) that are not reserved to the Management Board by this Regulation. Decisions shall be adopted by consensus.

Article 11

Director

1. The Centre shall be headed by a Director appointed by the Management Board on a proposal from the Commission for a five-year term, which shall be renewable.

2. Before appointment to a first term, out of a maximum of two terms, the candidate selected by the Management Board for the post of Director shall be invited without delay to make a statement before the European Parliament and answer questions put by members of that institution.

3. The Director shall be responsible for: (a) preparing and implementing the decisions and programmes adopted by the Management Board, (b) day-to-day administration, (c) preparing the Centre's work programmes, (d) the preparation of the draft estimate of the Centre's revenue and expenditure and the implementation of the budget, (e) the preparation and publication of the reports provided for in this Regulation, (f) managing all staff-related matters, and in particular exercising the powers which are devolved on the appointing authority, (g) defining the Centre's organisational structure and submitting it to the Management Board for approval, (h) the performance of the tasks referred to in Articles 1 and 2, (i) carrying out a regular assessment of the Centre's work.

4. The Director shall be accountable for his activities to the Management Board.

5. The Director shall be the Centre's legal representative.

Article 12

Hearing of the Director and of the Chairperson of the Management Board before the European Parliament

Each year the Director shall submit to the European Parliament the general report on the Centre's activities. The European Parliament may also ask for a hearing with the Director and the Chairperson of the Management Board on any subject related to the Centre's activities.

Article 13

Scientific Committee

1. The Management Board and the Director shall be assisted by a Scientific Committee which shall deliver an opinion where provided for in this Regulation on any scientific matter concerning the Centre's activities which the Management Board or the Director may submit to it. The opinions of the Scientific Committee shall be published.

2. The Scientific Committee shall consist of at most fifteen well-known scientists appointed in view of their scientific excellence and their independence by the Management Board, following the publication of a call for expressions of interest in the Official Journal of the European Union. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant scientific fields linked to the problems of drugs and drug addiction. The members of the Scientific Committee shall be appointed in a personal capacity and shall give their opinions completely independently of the Member States and the Community Institutions. The Scientific Committee shall take into account the various positions expressed in national expert opinions, if available, before delivering any opinion. ▼M1 Chun críche measúnú a dhéanamh ar na rioscaí a ghabhann leis an tsubstaint shícighníomhach nua nó leis an ngrúpa substaintí sícighníomhacha nua, féadfar an Coiste Eolaíochta a leathnú tríd an nós imeachta a leagtar síos in Airteagal 5c(4) a chomhlíonadh. ▼B

3. Members shall serve on the Scientific Committee for a three-year period, which shall be renewable.

4. The Scientific Committee shall elect its chairperson for a three-year period. It shall be convened by its chairperson at least once a year.

Article 14

Drawing up of the budget

1. Estimates of all the revenue and expenditure of the Centre shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the budget of the Centre.

2. The revenue and expenditure shown in the budget shall be in balance.

3. The Centre's revenue shall, without prejudice to other resources, consist of a subsidy from the Community entered in the general budget of the European Union (Commission Section), payments for services rendered and any financial contributions from the organisations and bodies and third countries referred to in Articles 20 and 21 respectively.

4. The Centre's expenditure shall include: (a) staff remuneration, administrative and infrastructure expenses, and operating costs; (b) expenditure in support of the Reitox focal points.

5. Each year the Management Board, on the basis of a draft drawn up by the Director, shall produce an estimate of revenue and expenditure for the Centre for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March, together with the Centre's work programme. The estimate shall be forwarded by the Commission to the European Parliament and the Council (hereinafter referred to as the ‘budgetary authority’) together with the preliminary draft general budget of the European Union.

6. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

7. The budgetary authority shall authorise the appropriations for the subsidy to the Centre and shall adopt the establishment plan for the Centre.

8. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly.

9. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.

Article 15

Implementation of the budget

1. The Director shall implement the Centre's budget.

2. By 1 March following each financial year, the Centre's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities ( 6 ) (hereinafter referred to as ‘the general Financial Regulation’).

3. By 31 March following each financial year, the Commission's accounting officer shall forward the Centre's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and to the Council.

4. On receipt of the Court of Auditors' observations on the Centre's provisional accounts, pursuant to Article 129 of the general Financial Regulation, the Director shall draw up the Centre's final accounts under his own responsibility and submit them to the Management Board for an opinion.

5. The Management Board shall deliver an opinion on the Centre's final accounts.

6. The Director shall, by 1 July following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion. The final accounts shall be published.

7. The Director shall send the Court of Auditors a reply to its observations by 30 September. He shall also send this reply to the Management Board.

8. The Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation.

9. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Director in respect of the implementation of the budget for year N.

10. The financial rules applicable to the Centre shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 ( 7 ) on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 unless specifically required for the Centre's operation and with the Commission's prior consent.

Article 16

Combating fraud

1. In order to combat fraud, corruption and any other illegal activities affecting the Communities' financial interests, the provisions of Regulation (EC) No 1073/1999 shall apply without restriction to the Centre.

2. The decisions concerning funding and the implementing agreements and instruments resulting from them shall explicitly stipulate that the Court of Auditors and OLAF may carry out, if necessary, on-the-spot checks at the premises of the recipients of the Centre's funding.

Article 17

Privileges and immunities

The Protocol on the Privileges and Immunities of the European Communities shall apply to the Centre.

Article 18

Staff Regulations

The Staff Regulations of officials of the European Communities and the Conditions of Employment of other servants of the European Communities and the rules adopted jointly by the Community Institutions for the purpose of applying those Staff Regulations and Conditions of Employment shall apply to the staff of the Centre.

Where it engages staff from third countries following the conclusion of the agreements referred to in Article 21, the Centre shall, in any event, comply with the Staff Regulations and Conditions of Employment referred to in paragraph 1 of this Article.

The Centre shall exercise in respect of its staff the powers devolved to the appointing authority.

The Management Board shall, in agreement with the Commission, adopt the appropriate implementing rules in accordance with the Staff Regulations, Article 110, and the Conditions of Employment referred to in paragraph 1.

The Management Board may adopt provisions to allow national experts from other Member States to be employed on secondment at the Centre.

Article 19

Liability

1. The contractual liability of the Centre shall be governed by the law applicable to the contract in question. The Court of Justice shall have jurisdiction pursuant to an arbitration clause contained in a contract concluded by the Centre.

2. In the case of non-contractual liability, the Centre shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by the Centre or its staff in the performance of their duties. The Court of Justice shall have jurisdiction in disputes relating to the compensation of any such damage.

3. The personal liability of its staff towards the Centre shall be governed by the provisions applying to the staff of the Centre.

Article 20

Cooperation with other organisations and bodies

Without prejudice to relations which the Commission may maintain pursuant to Article 302 of the Treaty, the Centre shall actively seek to cooperate with international organisations and other, particularly European, governmental and non-governmental bodies competent in the sector of drugs.

Such cooperation shall be based on working arrangements concluded with the organisations and bodies referred to in the first paragraph. Those arrangements shall be adopted by the Management Board on the basis of a draft submitted by the Director and after the Commission has delivered an opinion. Where the Commission expresses its disagreement with these arrangements, the Management Board shall adopt them by a three-fourths majority of the members with a right to vote.

Article 21

Participation of third countries

The Centre shall be open to the participation of any third country that shares the interest of the Community and of its Member States in the Centre's objectives and work, on the basis of agreements entered into between such third countries and the Community on the basis of Article 300 of the Treaty.

Article 22

Jurisdiction of the Court of Justice

The Court of Justice shall have jurisdiction in actions brought against the Centre under Article 230 of the Treaty.

Article 23

Evaluation report

The Commission shall initiate an external evaluation of the Centre every six years to coincide with the completion of two of the Centre's three-year work programmes. Such evaluations shall also include the Reitox system. The Commission shall forward the evaluation report to the European Parliament, the Council and the Management Board.

In that context, the Commission shall, if appropriate, present a proposal for revision of the provisions of this Regulation in the light of developments in respect of regulatory agencies, in accordance with the procedure laid down in Article 251 of the Treaty.

Article 24

Repeal

Regulation (EEC) No 302/93 is hereby repealed.

References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III.

Article 25

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

A. The work of the Centre shall be carried out with due regard to the respective powers of the Community and its Member States in the area of drugs, as those powers are defined by the Treaty. It shall cover the various facets of the drugs and drug addiction phenomenon, and the solutions applied. In doing so, the Centre shall be guided by the Drugs Strategies and Action Plans adopted by the European Union. The Centre shall focus on the following priority areas: 1) monitoring the state of the drugs problem, in particular using epidemiological or other indicators, and monitoring emerging trends, in particular those involving poly-drug use; 2) monitoring the solutions applied to drug-related problems; providing information on best practices in the Member States and facilitating the exchange of such practices among them; 3) assessing the risks of new psychoactive substances and maintaining a rapid information system with regard to their use and also regarding new methods of using existing psychoactive substances; 4) developing tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate European Union policies.

B. The Commission shall make available to the Centre, for dissemination, the information and statistical data which it possesses pursuant to its powers.









ANNEX II

REPEALED REGULATION AND SUCCESSIVE AMENDMENTS







Council Regulation (EEC) No 302/93 OJ L 36, 12.2.1993, p. 1. Council Regulation (EC) No 3294/94 OJ L 341, 30.12.1994, p. 7. Council Regulation (EC) No 2220/2000 OJ L 253, 7.10.2000, p. 1. Council Regulation (EC) No 1651/2003 OJ L 245, 29.9.2003, p. 30.









ANNEX III

CORRELATION TABLE







Council Regulation (EEC) No 302/93 This Regulation Article 1 Article 1 — Article 1(3), second and third sentences Article 2(A), sub-heading Article 2(a), sub-heading Article 2(A)(1) Article 2(a)(i), first phrase — Article 2(a)(i), second and third phrases Article 2(A)(2) to (5) Article 2(a)(ii) to (v) Article 2(B), sub-heading Article 2(b), sub-heading Article 2(B)(6), first phrase Article 2(b)(i), first phrase — Article 2(b)(i), second phrase Article 2(B)(7) Article 2(b)(ii) Article 2(C), sub-heading Article 2(c), sub-heading Article 2(C)(8) to (10) Article 2(c)(i) to (iii) Article 2(D), sub-heading Article 2(d), sub-heading Article 2(D)(11) to (13) Article 2(d)(i), (ii) and (iv) — Article 2(d)(iii) and (v) — Article 2(e) Article 3 Article 4 Article 4 Article 3 Article 5(1) Article 5(1) — Article 5(2), (3) and (4) Article 5(4) Article 5(5) Article 6(2) and (3) Article 6(1) — Article 6(2) Article 6a Article 7 Article 7 Article 8 — Article 8, heading — Article 8 (2) Article 8(1) Article 9(1), first, fourth and fifth subparagraphs Article 8(2) Article 9(1), second and third subparagraphs; Article 9(2); Article 9(3), second sentence — Article 9(3), first and third sentences Article 8(3) Article 9(4) Article 8(4) Article 9(5), first and third sentences — Article 9(5), second sentence — Article 9(6) Article 8(5) and (6) Article 9(7) and (8) — Article 10 Article 9(1), first subparagraph Article 11(1) — Article 11(2) Article 9(1), second subparagraph Article 11(3) Article 9(1), second subparagraph, first to sixth indent Article 11(3)(a) to (f), first phrase — Article 11(3)(f), second phrase — Article 11(3)(g) Article 9(1), second subparagraph, seventh indent Article 11(3)(h) — Article 11(3)(i) Article 9(2) and (3) Article 11(4) and (5) — Article 12 Article 10(1) Article 13(1) Article 10(2) Article 13(2), first and fourth subparagraphs — Article 13(2), second and third subparagraphs Article 10(3), (4) and (5) Article 13(3) and (4) Article 11(1) to (6) Article 14(1) to (5) Article 11(7) to (10) Article 14(6) to (9) Article 11a(1) to (5) Article 15(1) to (5) Article 11a(6) and (7) Article 15(6) Article 11a(8) to (11) Article 15(7) to (10) — Article 16 Article 12 Article 20 — Article 20, second subparagraph Article 13(1) Article 21 Article 13(2) — Article 14 Article 17 Article 15 Article 18, first, third and fourth subparagraphs — Article 18, second and fifth subparagraphs Article 16 Article 19 Article 17 Article 22 Article 18 Article 23, first subparagraph, first and third sentences — Article 23, first subparagraph, second sentence — Article 23, second subparagraph — Article 24 Article 19 Article 25 Annex, paragraph A, first subparagraph Annex I, paragraph A, first subparagraph, first sentence — Annex I, paragraph A, first subparagraph, second and third sentences — Annex I, paragraph A, second subparagraph, points (1) to (4) Annex, paragraph A, second subparagraph, points 1 to 5 — Annex, paragraph B Annex I, paragraph B Annex, paragraph C — — Annex II — Annex III