2012-02-09T17:02:56

type	change in	new
added	activities	date 2009-07-23 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=JOINT-TEXT&mode=XML&reference=C7-2009-0189&language=EN text PURPOSE: to present the final accounts of the European Medicines Agency for the financial year 2008. CONTENT: this document sets out a detailed account of the implementation of the European Medicines Agency's budget for the financial year 2008. It notes that the final budget amounts to EUR 182.9 million in 2008 (compared to EUR 163.1 million in 2007), representing a 21.9% Community subsidy (excluding subsidy for orphan medicines). As regards the staffing policy, the Agency, whose head office is in London (United Kingdom), officially set out 481 posts in its establishment plan. 469 of these posts are currently occupied with 118 other posts (auxiliary agents, contract agents seconded national experts, employment agency staff) totalling 587 posts assigned to operational and administrative tasks. Throughout 2008, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Medicinal Products for Human Use · replied to 103 applications for marketing authorisations and delivered 68 favourable opinions. The average evaluation time dedicated was 184 days · delivered 2 122 opinions after authorisation · drafted 193 587 Pharmacovigilance reports and 391 periodic safety update reports · delivered 263 scientific advice finalised: 263 and 14 522 procedures for mutual recognition · made 271 applications for paediatric investigation plans and relating to 395 indication(new task). Medicinal Products for Veterinary Use · replied to 13 new applications and 100 applications in respect of variants · carried out 253 inspections. Orphan Medicinal Products · made 119 applications and gave 86 favourable opinions. SMEs · replied to 242 requests for SME status · replied to 84 applications for fee reduction or deferrals. The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/htms/general/manage/ar.htm type Non-legislative basic document published title SEC(2009)1089 body type Non-legislative basic document published body EP date 2009-07-23 type Date date 2009-07-23 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=JOINT-TEXT&mode=XML&reference=C7-2009-0189&language=EN text PURPOSE: to present the final accounts of the European Medicines Agency for the financial year 2008. CONTENT: this document sets out a detailed account of the implementation of the European Medicines Agency's budget for the financial year 2008. It notes that the final budget amounts to EUR 182.9 million in 2008 (compared to EUR 163.1 million in 2007), representing a 21.9% Community subsidy (excluding subsidy for orphan medicines). As regards the staffing policy, the Agency, whose head office is in London (United Kingdom), officially set out 481 posts in its establishment plan. 469 of these posts are currently occupied with 118 other posts (auxiliary agents, contract agents seconded national experts, employment agency staff) totalling 587 posts assigned to operational and administrative tasks. Throughout 2008, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Medicinal Products for Human Use · replied to 103 applications for marketing authorisations and delivered 68 favourable opinions. The average evaluation time dedicated was 184 days · delivered 2 122 opinions after authorisation · drafted 193 587 Pharmacovigilance reports and 391 periodic safety update reports · delivered 263 scientific advice finalised: 263 and 14 522 procedures for mutual recognition · made 271 applications for paediatric investigation plans and relating to 395 indication(new task). Medicinal Products for Veterinary Use · replied to 13 new applications and 100 applications in respect of variants · carried out 253 inspections. Orphan Medicinal Products · made 119 applications and gave 86 favourable opinions. SMEs · replied to 242 requests for SME status · replied to 84 applications for fee reduction or deferrals. The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/htms/general/manage/ar.htm type Non-legislative basic document title SEC(2009)1089 body EC commission DG Budget Commissioner ŠEMETA Algirdas type Non-legislative basic document date 2009-10-07 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP responsible True committee CONT date 2009-10-01 committee_full Budgetary Control rapporteur group EPP name MATHIEU Véronique body EP responsible False committee ENVI date 2009-10-06 committee_full Environment, Public Health and Food Safety rapporteur group S&D name HAUG Jutta date 2010-02-03 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE430.483 type Committee draft report title PE430.483 body EP type Committee draft report date 2010-02-16 body CSL type Council Meeting council Economic and Financial Affairs ECOFIN meeting_id 2994 date 2010-03-23 text The Committee on Budgetary Control adopted the report by Véronique MATHIEU (EPP, FR) on discharge to be granted to the European Medicines Agency, calling on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the Agency's budget for the financial year 2008. Noting that the Agency's annual accounts for the financial year 2008 are reliable, and the underlying transactions are legal and regular, MEPs approve the closure of the Agency's accounts. However, they make a number of recommendations that need to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on financial management and control of EU agencies (see 2010/2007(INI): carry over of appropriations: Members are concerned that the Court of Auditors has pointed out that the budget appropriations carried over and cancelled have amounted respectively to EUR 36 million (19.7% of the budget). They point out, as noted in previous financial years, that the high level of carry-overs for administrative expenditure was mainly due to IT expenditure. They are consequently concerned as this situation has existed for a number of years and is at odds with the annuality principle; procurement procedures: Members called on the Agency to improve the quality of its procurement procedures so as to put an end to the shortcomings identified by the Court of Auditors. They take note of the Agency's longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the exchange rate of sterling. MEPs expect the Agency to manage such transactions prudently and recommend that a working group be set up to observe and closely monitor the hedging strategy; revenue from fees: Members point out that the fees charged for evaluation services are the main source of the Agency's revenue, accounting for 70.2% of its total revenue in 2008. They note that the Agency reported EUR 2 046 000 in income from interest in 2008. They conclude from the financial statements and from the level of the interest payments that the Agency has a permanently extremely high level of cash holdings (on 31 December 2008 the Agency's cash holdings amounted to EUR 41.887 million). They ask the Commission to examine what scope there is for helping to ensure that the cash holdings are managed entirely on a needs-orientated basis and what changes of approach are necessary in order to keep the Agency's cash holdings permanently as low as possible; internal audit: lastly, Members ask the Agency to implement the recommendations from the Internal Audit Service (IAS) in particular as regards the conflicts of interest. body EP committees body EP responsible True committee CONT date 2009-10-01 committee_full Budgetary Control rapporteur group EPP name MATHIEU Véronique body EP responsible False committee ENVI date 2009-10-06 committee_full Environment, Public Health and Food Safety rapporteur group S&D name HAUG Jutta type Vote in committee, 1st reading/single reading date 2010-03-26 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2010-0078&language=EN type Committee report tabled for plenary, single reading title A7-0078/2010 body type Committee report tabled for plenary, single reading date 2010-03-26 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2010-0078&language=EN type Committee report tabled for plenary, single reading title A7-0078/2010 body EP type Committee report tabled for plenary, single reading date 2010-04-21 body EP type Debate in Parliament date 2010-05-05 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2010-0108 text The European Parliament adopted by 553 votes to 30, with 57 abstentions, a decision on discharge to be granted to the Executive Director of the European Medicines Agency in respect of the implementation of its budget for the financial year 2008. The decision to grant discharge is also an approval of the closure of the accounts of this EU agency. Furthermore, Parliament adopted a resolution with observations which are an integral part of the decision to grant discharge to this Agency. The main points are as follows: carry over of appropriations: Parliament is concerned that the Court of Auditors has pointed out that the budget appropriations carried over and cancelled have amounted respectively to EUR 36 million (19.7% of the budget). It points out, as noted in previous financial years, that the high level of carry-overs for administrative expenditure was mainly due to IT expenditure. It is, consequently, concerned as this situation has existed for a number of years and is at odds with the annuality principle; procurement procedures: Parliament calls on the Agency to improve the quality of its procurement procedures so as to put an end to the shortcomings identified by the Court of Auditors. It takes note of the Agency's longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the exchange rate of sterling. Parliament expects the Agency to manage such transactions prudently and recommends that a working group be set up to observe and closely monitor the hedging strategy; revenue from fees: Parliament points out that the fees charged for evaluation services are the main source of the Agency's revenue, accounting for 70.2% of its total revenue in 2008. It notes that the Agency reported EUR 2 046 000 in income from interest in 2008. It concludes from the financial statements and from the level of the interest payments that the Agency has a permanently extremely high level of cash holdings (on 31 December 2008, the Agency's cash holdings amounted to EUR 41.887 million). It asks the Commission to examine what scope there is for helping to ensure that the cash holdings are managed entirely on a needs-orientated basis and what changes of approach are necessary in order to keep the Agency's cash holdings permanently as low as possible; internal audit: lastly, Parliament asks the Agency to implement the recommendations from the Internal Audit Service (IAS) in particular as regards the conflicts of interest. Noting that the Agency's annual accounts for the financial year 2008 are reliable, and the underlying transactions are legal and regular, Parliament approves the closure of its accounts and refers to the general recommendations that appear in the draft resolution on financial management and control of EU agencies (see 2010/2007(INI) adopted in parallel). type Decision by Parliament, 1st reading/single reading title T7-0108/2010 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=18219&l=en type Results of vote in Parliament title Results of vote in Parliament body EP type Text adopted by Parliament, single reading date 2010-09-25 text PURPOSE: to grant discharge to the European Medicines Agency for the financial year 2008. LEGISLATIVE ACT: Decision 2010/528/EU of the European Parliament on the discharge for the implementation of the budget of the European Medicines Agency for the financial year 2008. CONTENT: with the present decision, the European Parliament grants discharge to the Executive Director of the European Medicines Agency for the financial year 2008. This decision is in line with the European Parliament's resolution adopted on 5 May 2010 and comprises a series of observations that form an integral part of the discharge decision (please refer to the summary of the opinion of 5 May 2010). A parallel Decision, adopted on the same day, approves the closure of the accounts of this EU agency. type Final act published in Official Journal docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32010D0528 title Decision 2010/528 url http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2010:252:SOM:EN:HTML title OJ L 252 25.09.2010, p. 0164
added	committees	body EP responsible True committee CONT date 2009-10-01 committee_full Budgetary Control rapporteur group EPP name MATHIEU Véronique body EP responsible False committee ENVI date 2009-10-06 committee_full Environment, Public Health and Food Safety rapporteur group S&D name HAUG Jutta
added	links
added	other	body EC dg Budget commissioner ŠEMETA Algirdas
added	procedure	dossier_of_the_committee CONT/7/01104 reference 2009/2118(DEC) title 2008 discharge: European Medicines Agency EMEA stage_reached Procedure completed type DEC - Discharge procedure final url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32010D0528 title Decision 2010/528 subject 8.70.03.03 2008 discharge

Parltrack watcher Feed - /dossier/2009/2118(DEC) changes

2012-02-09T17:02:56