Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | CONT |
SARVAMAA Petri ( PPE)
|
KADENBACH Karin ( S&D),
CZARNECKI Ryszard ( ECR),
ALI Nedzhmi ( ALDE),
STAES Bart ( Verts/ALE),
KAPPEL Barbara ( ENF)
|
| Committee Opinion | ENVI |
VĂLEAN Adina-Ioana ( PPE)
|
Anneli JÄÄTTEENMÄKI ( ALDE),
Karin KADENBACH ( S&D),
Bolesław G. PIECHA ( ECR)
|
Lead committee dossier:
Subjects
Events
The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) for the financial year 2017 and to approve the closure of the accounts for the financial year in question.
Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2017 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 492 votes to 121 with 24 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the draft resolution on performance, financial management and control of EU agencies :
Agency’s financial statements
The European Medicines Agency’s final budget for the financial year 2017 was EUR 331 266 000, representing an increase of 7.41 % compared to 2016. The Agency is a fee-funded agency, with 86 % of its 2017 revenue stemming from fees paid by the pharmaceutical industry for services provided, and 12 % stemming from the Union budget.
Budget and financial management
The budget monitoring efforts during the financial year 2017 resulted in a budget implementation rate of 92.92 %, representing a decrease of 3.38 % compared to 2016. Payment appropriations execution rate was 76.62 %, representing a decrease of 5.73 % compared to 2016. Parliament regretted that the cancellations of carry-overs from 2016 to 2017 amounted to EUR 4 350 908, representing 10.11 % of the total amount carried-over, showing a notable increase of 5.65 % in comparison to 2016. It called on the Agency to report to the discharge authority on the measures taken to ensure complete use of the appropriations carried-over, in order to avoid substantial resources being de-committed.
Members also made a series of observations regarding performance, staff, procurement and internal controls.
In particular, they noted that:
- the Agency implemented a new and improved version of the EudraVigilance system, an information system used to report suspected side effects of medicines;
- a number of the Agency’s activities were delayed or postponed due to Brexit or external circumstances;
- the Agency recommended 110 new medicines for marketing authorisation (92 for human use and 18 for veterinary use), and that those included 42 new active substances (35 for human use and 7 for veterinary use);
- on 31 December 2017, the establishment plan was 97.82 % executed, with 583 temporary agents appointed out of 596 temporary agents authorised under the Union budget;
- the staff expenses increased by EUR 10 million. The Agency is asked to report comprehensively on this expenditure and urged not to replace permanent staff by more expensive contract agents;
- the Agency received 25 reports on cases of whistleblowing from an external source, 15 cases were closed and 10 cases are still ongoing;
- the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency will move to Amsterdam at the beginning of 2019 and that the Agency’s accounts include provisions for related costs amounting to EUR 18 600 000. Parliament regretted that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause. Efforts should be made to minimise the financial, administrative and operational impact of the unfavourable lease agreement.
The Committee on Budgetary Control adopted the report by Petri SARVAMAA (EPP, FI) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2017.
The committee called 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 2017.
Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2017 were reliable and that the underlying transactions were legal and regular, Members called on Parliament to approve the closure of the Agency’s accounts.
They made, however, a number of recommendations that needed to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies :
Agency’s financial statements
The European Medicines Agency’s final budget for the financial year 2017 was EUR 331 266 000, representing an increase of 7.41 % compared to 2016. The Agency is a fee-funded agency, with 86 % of its 2017 revenue stemming from fees paid by the pharmaceutical industry for services provided, and 12 % stemming from the Union budget.
Budget and financial management
The budget monitoring efforts during the financial year 2017 resulted in a budget implementation rate of 92.92 %, representing a decrease of 3.38 % compared to 2016. Payment appropriations execution rate was 76.62 %, representing a decrease of 5.73 % compared to 2016.
Members regretted that the cancellations of carry-overs from 2016 to 2017 amounted to EUR 4 350 908, representing 10.11 % of the total amount carried-over, showing a notable increase of 5.65 % in comparison to 2016. They called on the Agency to report to the discharge authority on the measures taken to ensure complete use of the appropriations carried-over, in order to avoid substantial resources being de-committed.
Members also made a series of observations regarding performance, staff, procurement and internal controls.
In particular, they noted that:
- the Agency implemented a new and improved version of the EudraVigilance system, an information system used to report suspected side effects of medicines;
- a number of the Agency’s activities were delayed or postponed due to Brexit or external circumstances;
- the Agency recommended 110 new medicines for marketing authorisation (92 for human use and 18 for veterinary use), and that those included 42 new active substances (35 for human use and 7 for veterinary use);
- on 31 December 2017, the establishment plan was 97.82 % executed, with 583 temporary agents appointed out of 596 temporary agents authorised under the Union budget;
- the staff expenses increased by EUR 10 million. The Agency is asked to report comprehensively on this expenditure and urged not to replace permanent staff by more expensive contract agents;
- that in 2017 the Agency received 25 reports on cases of whistleblowing from an external source, 15 cases were closed in 2017 and 10 cases are still ongoing;
- the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency will move to Amsterdam at the beginning of 2019 and that the Agency’s accounts include provisions for related costs amounting to EUR 18 600 000. Members regretted that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause. Efforts should be made to minimise the financial, administrative and operational impact of the unfavourable lease agreement.
Having examined the revenue and expenditure accounts for the financial year 2017 and the balance sheet as at 31 December 2017 of the European Medicines Agency (EMA), as well as the Court of Auditors' report on the annual accounts of the Agency for the financial year 2017, accompanied by the Agency's replies to the Court's observations, the Council recommended the European Parliament to give a discharge to the Executive Director of the Agency in respect of the implementation of the budget for the financial year 2017.
The Council welcomed the Court's opinion that the Agency's annual accounts present fairly its financial position as at 31 December 2017 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of the Agency's Financial Regulation, and that the underlying transactions for 2017 are legal and regular in all material respects.
Nevertheless, the following observations were made:
- financial programming : the Council encouraged the Agency to continue improving its financial programming and monitoring of the budget implementation, taking into account the decision on the future location of the Agency;
- accounting : deficiencies were found by the Court in the Agency's accounting environment. The Council called on the Agency to take appropriate actions mainly to ensure the accounting officer's independence, as well as to remedy any unjustified delays in the re-validation of its accounting system;
- action plan : the Council welcomed the efforts made by the Agency to implement an action plan established with a view to address the Court's recommendations from previous years to remedy the weaknesses found by the Court in the Agency's information, communication and technology management control. The Council encourages the Agency to promptly assess the measures taken;
- staff : the Council regretted the Court's finding about the critical dependence of the Agency on the extensive use of external consultants, as well as about an inadequate control over project development and implementation. While welcoming the implementation of some measures, it encouraged the Agency to continue improving the development of a structured and systematic policy governing the use of consultants.
PURPOSE: presentation of the EU Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2017, together with the Agency’s reply.
CONTENT: the Court of Auditors carried out the audit on the annual accounts of the European Medicines Agency (EMA).
In brief, the Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use.
Statement of assurance and reliability of the accounts
The Court considered that:
- the Agency’s annual accounts present fairly, in all material respects, its financial position as at 31 December 2017 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation and the accounting rules adopted by the Commission’s accounting officer;
- the transactions underlying the annual accounts for the year ended 31 December 2017 are legal and regular in all material respects.
Emphasis of matter
Without calling into question its opinion, the Court draws attention to the fact that the United Kingdom (UK) notified the European Council on 29 March 2017 of its decision to withdraw from the European Union. An agreement setting out the arrangements for its withdrawal is currently being negotiated. The accounts and related notes of the Agency, which is located in London, were prepared using the information available at the date of signature (1 June 2018).
On 20 November 2017, the General Affairs Council of the European Union agreed to move the seat of the Agency to Amsterdam, The Netherlands. The removal to temporary premises is planned for the beginning of 2019 and the Agency’s accounts include provisions for related costs amounting to EUR 18.6 million.
Moreover, the lease agreement for the Agency’s current premises in London sets a rental period until 2039 with no exit clause. The notes to the accounts disclose an amount of EUR 489 million remaining rent until 2039, of which a maximum amount of EUR 465 million corresponding to the lease period after the Agency’s planned move to Amsterdam is disclosed as a contingent liability.
The report also makes a series of observations on the budgetary and financial management of the Agency, accompanied by the latter’s response. The main observations may be summarised as follows:
The Court’s observations
Financial management
Agencies should introduce a single solution for the electronic exchange and storage of information with third parties participating in public procurement procedures (e-procurement). As the same requirement exists for all EU Institutions, the Commission is developing a comprehensive IT solution covering all phases of public procurement procedures. The Commission launched tools for electronic invoicing (e-invoicing), for the electronic publication of documents related to contract notices (e-tendering) and for the electronic submission of tenders (e-submission). By the end of 2017, the Agency had introduced e-tendering for certain procedures, but not e-invoicing and e-submission.
On the management of consulting services, the Court noted the excessive use of consulting firms for external expertise. Control over project development and implementation was also inadequate and that projects were considerably delayed and costs were escalating.
Several measures were taken to improve the situation. The Agency is moving to the use of fixed price rather than time and means based consulting contracts, allowing for a better cost management.
The Agency’s reply
Financial management
The Agency stated that by the end of 2017 the Agency had introduced e-tendering for all procedures above the directive threshold and email tender procedures for procedures below the directive threshold. The Agency has not introduced e-invoicing and e-submission, but in September 2017 the Agency signed a Memorandum of Understand with the European Commission for access to and the use of e-submission and is awaiting a date from the European Commission for the same.
Lastly, the Court of Auditors’ report contains a summary of the Agency’s key figures in 2017:
Budget
EUR 331 million.
Staff
766 including officials, temporary and contract staff and seconded national experts.
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2017, as part of the 2017 discharge procedure.
Analysis of the accounts of the European Medicines Agency (EMA) .
CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.
This Commission document concerns the EU's consolidated accounts for the year 2017 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.
It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cash flows of the EU institutions and bodies with a view to granting discharge.
Discharge procedure : the final step of a budget lifecycle is the discharge . It is the decision by which the European Parliament ‘ releases ’ the Commission from its responsibility for management of a given budget by marking the end of that budget's existence. It is granted by the European Parliament on the recommendation of the Council.
The decision is based in particular on the European Court of Auditors reports, in particular its annual report, in which the Court provides a Statement of Assurance (DAS) on the legality and regularity of transactions (payments and commitments).
The procedure results in the granting, postponement or refusal of discharge.
The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.
All EU institutions and other agencies, bodies and joint undertakings are subject to their own discharge procedures.
The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.
The year 2017 was a challenging year for EMA. The impact of the UK’s decision to withdraw from the European Union left its mark. As well as continuing with its day-to-day work and successfully delivering most of its work plan, the Agency worked with the national competent authorities to prepare the network for the impact of the UK’s withdrawal.
The Agency received the long-awaited decision on its new home. On 20 November 2017, the General Affairs Council (Art. 50) decided on Amsterdam as EMA’s new location . The decision ended a long period of uncertainty and allowed the Agency to begin more concrete decision-making on how to ensure a successful move and retain majority of the existing staff.
As regards Agency’s accounts , these are presented in detail in the document on the consolidated annual accounts of the European Union for 2017:
Commitment appropriations :
available: EUR 331 million; made: EUR 302 million.
Payment appropriations :
available: EUR 347 million; made: EUR 292 million.
For further details on expenditure, please refer to the final accounts of the EMA .
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2017, as part of the 2017 discharge procedure.
Analysis of the accounts of the European Medicines Agency (EMA) .
CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.
This Commission document concerns the EU's consolidated accounts for the year 2017 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.
It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cash flows of the EU institutions and bodies with a view to granting discharge.
Discharge procedure : the final step of a budget lifecycle is the discharge . It is the decision by which the European Parliament ‘ releases ’ the Commission from its responsibility for management of a given budget by marking the end of that budget's existence. It is granted by the European Parliament on the recommendation of the Council.
The decision is based in particular on the European Court of Auditors reports, in particular its annual report, in which the Court provides a Statement of Assurance (DAS) on the legality and regularity of transactions (payments and commitments).
The procedure results in the granting, postponement or refusal of discharge.
The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.
All EU institutions and other agencies, bodies and joint undertakings are subject to their own discharge procedures.
The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.
The year 2017 was a challenging year for EMA. The impact of the UK’s decision to withdraw from the European Union left its mark. As well as continuing with its day-to-day work and successfully delivering most of its work plan, the Agency worked with the national competent authorities to prepare the network for the impact of the UK’s withdrawal.
The Agency received the long-awaited decision on its new home. On 20 November 2017, the General Affairs Council (Art. 50) decided on Amsterdam as EMA’s new location . The decision ended a long period of uncertainty and allowed the Agency to begin more concrete decision-making on how to ensure a successful move and retain majority of the existing staff.
As regards Agency’s accounts , these are presented in detail in the document on the consolidated annual accounts of the European Union for 2017:
Commitment appropriations :
available: EUR 331 million; made: EUR 302 million.
Payment appropriations :
available: EUR 347 million; made: EUR 292 million.
For further details on expenditure, please refer to the final accounts of the EMA .
Documents
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament: T8-0271/2019
- Committee report tabled for plenary: A8-0135/2019
- Supplementary non-legislative basic document: 05825/2019
- Amendments tabled in committee: PE634.505
- Committee opinion: PE627.701
- Committee draft report: PE626.799
- Court of Auditors: opinion, report: N8-0012/2019
- Court of Auditors: opinion, report: OJ C 434 30.11.2018, p. 0001
- Non-legislative basic document: COM(2018)0521
- Non-legislative basic document: EUR-Lex
- Non-legislative basic document published: COM(2018)0521
- Non-legislative basic document published: EUR-Lex
- Non-legislative basic document: COM(2018)0521 EUR-Lex
- Court of Auditors: opinion, report: N8-0012/2019 OJ C 434 30.11.2018, p. 0001
- Committee draft report: PE626.799
- Committee opinion: PE627.701
- Supplementary non-legislative basic document: 05825/2019
- Amendments tabled in committee: PE634.505
Activities
- Alex MAYER
Plenary Speeches (1)
Votes
A8-0135/2019 - Petri Sarvamaa - Résolution 26/03/2019 17:52:05.000 #
GUE/NGL
NI
EFDDA8-0135/2019 - Petri Sarvamaa - Résolution #
| Amendments | Dossier |
| 16 |
2018/2185(DEC)
2018/12/12
ENVI
4 amendments...
Amendment 1 #
Draft opinion Paragraph 5 5. Reiterates the important role
Amendment 2 #
Draft opinion Paragraph 6 6. Stresses that a number of the Agency’s activities were delayed or postponed due to
Amendment 3 #
Draft opinion Paragraph 11 11.
Amendment 4 #
Draft opinion Paragraph 13 13.
source: 630.565
2019/01/31
CONT
12 amendments...
Amendment 1 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 10 #
Motion for a resolution Paragraph 15 b (new) 15 b. Acknowledges from the Agency that Pre-submission meetings contribute to the development of medicines; notes that in the light of the pre-submission meetings, the experts of CHMP perform both the role of consultant as of evaluator of the marketing authorisation applications; calls upon the Agency to at least publish a list of pre-submission activities, once the marketing authorisation has been given;
Amendment 11 #
Motion for a resolution Paragraph 17 17. Notes that the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency will move to Amsterdam at the beginning of 2019 and that the Agency’s accounts include provisions for related costs amounting to EUR 18 600 000; regrets that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause; deeply regrets that the notes to the accounts disclose an amount of EUR 489 000 000 remaining rent until 2039, of which a maximum amount of EUR 465 000 000 corresponding to the lease period after the Agency’s planned move to Amsterdam is disclosed as a contingent liability; urges the Agency and the European Commission to do
Amendment 12 #
Motion for a resolution Paragraph 19 19.
Amendment 2 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 3 #
Motion for a resolution Paragraph 7 Amendment 4 #
Motion for a resolution Paragraph 9 9. Notes with concern that, according to the Agency and to the Court’s report, while significant new tasks were assigned to the Agency, the Agency’s staff establishment plan was not increased in 2017, leading to a critical dependence on external expertise in affected areas; welcomes that the Management Board of EMA was verbally informed by DG SANTE representative that EMA’s request to hire up to 40 time-limited contract agents in 2019 has been accepted; welcomes the measures already taken by the Agency to mitigate the risks involved and calls on the Agency to report to the discharge authority on further decisions taken in order to improve the situation;
Amendment 5 #
Motion for a resolution Paragraph 10 10. Welcomes the suggestion of the Court to publish vacancy notices also on the website of the European Personnel Selection Office in order to increase publicity; understands the Agency’s concern regarding the high translation costs triggered by such publication;
Amendment 6 #
Motion for a resolution Paragraph 12 12. Stresses that the Agency’s clients - the pharmaceutical industry - pay for the procedure, not for the outcome of the Agency’s assessments; understands that according to the Agency it considers its recommendations to be made independently and that they, therefore, do not create conflicts of interest, in respect of which any potential risks are however duly considered, prevented and mitigated; expresses, however, concern at the potential conflict of interest that can arise if the Agency have to rely on membership fees as its main source of income; emphasizes the need for a steady and predictable flow of income from the Union budget, which is crucial also to planning, rather than having to rely on fees, which are unpredictable and vary from year to year;
Amendment 7 #
Motion for a resolution Paragraph 12 a (new) 12 a. Welcomes the fact that the Agency also requests all IT consultants to sign individual declarations of interest and confidentiality undertaking at the beginning of their assignment;
Amendment 8 #
Motion for a resolution Paragraph 14 14. Notes that the Agency meets with
Amendment 9 #
Motion for a resolution Paragraph 15 a (new) 15 a. Welcomes the inquiry that the European Ombudsman opened into the arrangements that the Agency has in place for engaging with medicine producers before they apply for authorisations to market their medicines in the Union and welcomes the fact that all interested parties are invited to put forward their comments on this issue, especially since the Agency’s income on fees and charges related to marketing authorisations increased by 14 million euros;
source: 634.505
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