The Community involvement with services of general interest goes beyond developing the single market, including providing for instruments to ensure standards of quality, the coordination of regulators and the evaluation of operations.

Only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards, should marketing authorisation be granted by the Community, and this should be done by means of a rapid procedure ensuring close cooperation between the Commission and Member States.

It is thus necessary to subject such products to an environmental risk-assessment procedure similar to the procedure under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(13), to be conducted in parallel with the evaluation, under a single Community procedure, of the quality, safety and efficacy of the product concerned.

The Member States shall envisage in the plans referred to in Articles 3(3) and defined in Article 9(b) of Regulation (EC) No 1260/1999 the means necessary to undertake studies, pilot projects, demonstration projects, training measures, technical assistance, the exchange of experience and publicity connected with the preparation, implementation, monitoring, evaluation or adjustment of the operational programmes and the single programming documents.

This VAMF will allow the pooling of national expertise, and through the coordination by the EMEA, a single evaluation of the concerned vaccine antigen.

To this end the concept of a plasma master file (PMF) should be introduced, in particular in order to allow the pooling of national expertise and through the coordination by the EMEA of a single evaluation.

Consideration shall be given to a single submission/evaluation/ quality systems assessment which simultaneously satisfies the requirements of each jurisdiction.

Where more than one programme is implemented in a given Member State, a single body may be given the task of conducting the external evaluation of all the programmes in that Member State.

Whereas only after a single scientific evaluation of the highest possible standard of the quality, safety or efficacy of technologically advanced medicinal products, to be undertaken within the European Agency for the Evaluation of Medicinal Products, should a marketing authorization be granted by the Community by a rapid procedure ensuring close cooperation between the Commission and Member States.

- By derogation from the provisions of the second indent of the present point (evaluation and certification), where a Plasma Master File corresponds only to blood/plasma-derived medicinal products the marketing authorisation of which is restricted to a single Member State, the scientific and technical evaluation of the said Plasma Master File shall be carried out by the national competent authority of that Member State.

in the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken at a Community level, lead to a single decision on the area of disagreement, binding on the Member States concerned.

(18) Taking into account the Community strategy for sustainable development and the results of the framework programme evaluations, steps should be taken to strengthen Community support in those energy fields that contribute to sustainable development by grouping them in a single programme - "Intelligent Energy - Europe" - comprising four specific areas.

Community support frameworks, operational programmes and single programming documents shall be re-examined and, if necessary, adapted at the initiative of the Member State or the Commission in agreement with the Member State, in accordance with this Title following the mid-term evaluation referred to in Article 42 and the allocation of the performance reserve referred to in Article 44.

Whereas the Council, meeting in the composition of Heads of State or Government, after having made an overall evaluation for each Member State, taking into account the above reports of the Commission and the European Monetary Institute, the opinion of the European Parliament and the Council's recommendations of 1 May 1998, considers that Belgium, Germany, Spain, France, Ireland, Italy, Luxembourg, the Netherlands, Austria, Portugal and Finland fulfil the necessary conditions for the adoption of the single currency,

Single survey evaluation and interpretation

Consideration shall be given to a single submission/evaluationquality systems assessment which simultaneously satisfies the requirements of each jurisdiction.

The Parties acknowledge that one objective could be the establishment where feasible of a single submission and evaluation procedure, applicable in both Parties, for the products covered by the Agreement.

The Community involvement with services of general interest goes beyond developing the single market, including providing for instruments to ensure standards of quality, the coordination of regulators and the evaluation of operations.

Since the properties of polymers are so varied, it is impossible to describe one single method setting out precisely the conditions for separation and evaluation which cover all eventualities and specificities occurring in the separation of polymers.

By derogation from the provisions of the second indent of the present point (evaluation and certification), where a Plasma Master File corresponds only to blood/plasma-derived medicinal products the marketing authorisation of which is restricted to a single Member State, the scientific and technical evaluation of the said Plasma Master File shall be carried out by the national competent authority of that Member State.

In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Community standard, leading to a single decision on the area of disagreement binding on the Member States concerned.

The biostatistical evaluation of the existing single dose study with replicate design (but showing non- bioequivalence) could be considered suitable to evaluate intra-individual variability and to determine the influence of the biopharmaceutical performance, in relation to the different release mechanisms (reservoir versus matrix).

Taking into account the Community strategy for sustainable development and the results of the framework programme evaluations, steps should be taken to strengthen Community support in those energy fields that contribute to sustainable development by grouping them in a single programme - "Intelligent Energy - Europe" - comprising four specific areas.

Only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards, should marketing authorisation be granted by the Community, and this should be done by means of a rapid procedure ensuring close cooperation between the Commission and Member States.

It is thus necessary to subject such products to an environmental risk-assessment procedure similar to the procedure under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(13), to be conducted in parallel with the evaluation, under a single Community procedure, of the quality, safety and efficacy of the product concerned.