Strengthen cooperation on pharmacovigilance, scientific advice, support to SMEs and the provision of information; Work within the network to establish an EU communications strategy; Work to ensure availability for the Agency of the highest-quality expertise at EU level for evaluation of medicines and for monitoring and assessing their safety; Establish an inventory of available scientific expertise in the European medicines network; identify and complement insufficient expertise and plan for succession of established expertise; Develop an EU competence-development strategy and strengthen competence development at EU level.

The company that makes Zavesca will complete the following studies to address the product’ s effectiveness and safety in type 1 Gaucher disease:  a post-marketing plan to inform doctors on how to use Zavesca and to get patients to report information on the safety of the medicine;  a study to follow up patients already in clinical trials, to continue assessment of the medicine’ s safety and effectiveness and to find out more about the neurological aspects of the disease;  a study to look at the effectiveness and safety of Zavesca in patients who switch from ERT;  a further study of the natural history of the disease, together with the European Working Group for Gaucher Disease (EWGGD).

In establishing the list of information to be recorded in the registers, account has been taken of the fact that other sets of information - such as the environmental risk assessment, the scientific studies, including studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for identification and detection, and all other information submitted by the notifier, methods and plans for monitoring the GMO(s) and for emergency response, and results of the post-market monitoring - are in principle accessible according to the relevant provisions of Directive 2001/18/EC, Regulation (EC) No 1946/2003 of the European Parliament and the Council of 15 July 2003 on transboundary movements of genetically modified organisms(2) and Regulation (EC) No 1049/2001 of the European Parliament and the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(3), and therefore need not be recorded.

Annual assessment, estimates and studies...........................................................

preparatory and feasibility studies for humanitarian operations and the assessment of humanitarian projects and plans,

At the Member States' request, and with their participation, the Commission may also assess the results of the Community's humanitarian operations and plans.

develop a plan for financing investments (directive specific), based on estimations of costs of alignment and realistic sources of public and private finance year-by-year,

to evaluate the effectiveness of action plans, programmes and measures implemented under this Protocol to eliminate to the fullest possible extent pollution of the marine environment."

Where the planned purchase of standard supplies may give rise to simultaneous contracts in separate lots, the estimated value of all those lots shall be taken as the basis for determining the applicable threshold.

In the case of multiannual operations, the financial statement shall contain the foreseeable schedule of annual requirements in terms of appropriations and posts and an evaluation of their medium-term financial impact.

providing information, to contribute towards the cost of these forms; whereas it is necessary to estimate the amount of Community funds required for this; whereas this amount must be in line with the financial perspective set out in the Interinstitutional Agreement of 29 June 1988 on Budgetary Discipline and Improvement of the Budgetary Procedure; whereas, in compliance with this Agreement, the appropriations actually available must be determined in accordance with budgetary procedure;