monitoring observation of the deadlinesfor various appeal proceedings

A. Timely pricing and reimbursement decisions compliance with the time limits

Declaration o n respect for time limits under the CO decision procedure 35 .

This covers the phase of EMEA activities from pre submission both for pre and post authorisation activities discussion with future applicants, through the evaluation by

to continue to achieve compliance with regulatory targets and deadlines for post authorisation issues under the centralised system

Finalise and implement the EMEA risk management strategy and collaborate with heads of national authorities on the development of a European risk management strategy

to continue to achieve compliance with regulatory targets and deadlines for post authorisation issues under the centralised system

3.2.4 In order for these procedures and time limits to be adhered to, the IMI system must function smoothly.

4.1.8 In order for these procedures and time limits to be adhered to, the IMI system must function smoothly.

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5.1 The Committee stresses its concerns regarding compliance with the dates laid down for the entry into force of Stage III B and Stage IV, and the respective type approval procedures.

5.1 The EESC stresses its concerns regarding compliance with the dates laid down for the entry into force of Stage III B and Stage IV, and the respective type approval procedures.

Fulfilment of these obligations during the lifetime of the agreements is ensured by the payment of sureties.

to continue to achieve compliance with regulatory targets and deadlines for scientific opinions for marketing authorisation applications under the centralised system

to process all applications submitted under the mutual recognition procedure according to the published best practice guide and in line with time requirements of the legislation

The Registrar shall, in particular, ensure that the deadlines and other formal conditions relating to the presentation of the appeal and of the statement of grounds are respected.

Calculation of time limits Duration of time limits Expiry of time limits in special cases

Adhere to regulatory timelines for the processing of type I, type II and line extension applications Keep workload evolution under review during 2002

Modification of deadlines

Extension of time limits

COMPUTATION OF TIME LIMITS

There is, on the other hand, an urgent need to press the Member States to make wider use of existing instruments for administrative cooperation and to comply with the deadlines and procedures laid down.

2.7.3 Transparency (access to data, compliance with deadlines) should be guaranteed during meetings between the European Commission and social partners, NGOs and the various civil society organisations.

A Best Practice Guide has been adopted and a list of ideal submission dates has been endorsed for applications to ensure adherence to the strict timetables.

3.2 There is, on the other hand, an urgent need to press the Member States to make wider use of existing instruments for administrative cooperation and to comply with the deadlines and procedures laid down.

4.12 Definition of time limits

1.11.2 The EESC considers that effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions.

1.11.2 The EESC considers that effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions.

1.12.2 The EESC considers that effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions.

Close cooperation between producers, Member States, the Commission and the EFSA and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme of work.

Incentive for Member States to comply with the time limits but effectiveness will depend on the willingness of economic operators to enforce their rights and on the level of sanctions decided by national judges.

Adhere to regulatory timelines for active review time by the CPMP Publication of summaries of opinion at the time of adoption by the CPMP Rapid publication of EPARs after the European Commission decision granting marketing authorisation

3.4.1 The EESC considers that effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions.

3.5.1 The EESC considers that effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions.

Upon the request of and in accordance with the timescales decided by the Executive Body, EMEP and other subsidiary bodies shall provide the Executive Body with relevant information on

Rule 70 Calculation of time limits

Summary of requirements and deadlines

Adhere to regulatory timelines for the processing of type I, type II and extension applications for marketing authorisations and for MRLs Keep workload evolution under review during 2002

Adhere to regulatory timelines for active review time by the CVMP Publication of summaries of opinion at the time of adoption by the CVMP Rapid publication of EPARs after the European Commission decision granting marketing authorisation

The Secretary also provides an action list after each AG meeting listing the tasks and deadlines that were allocated during that meeting .

(3) legal compliance means full implementation of applicable legal requirements, including permit conditions, relating to the environment

Any emission related maintenance performed on engines must be necessary to assure in use conformity with the relevant emission standards.

1.6 To ensure that the measures are complied with, the EESC suggests that the Commission publishes an appendix detailing the different deadlines and obligations for each type of vessel.

2.6 To ensure that the measures are complied with, the EESC suggests that the Commission publishes an appendix detailing the different deadlines and obligations for each type of vessel.

As a further safeguard, as noted above, the Commission s proposal includes the possibility of extending the timetable for meeting the limit value for benzene in areas where there is exceptional difficulty.