Withdrawal by a member from the Agency shall not affect its contractual obligations entered into pursuant to Article V or its financial obligations for the year in which it withdraws.

Withdrawal by a Member from the Agency shall not affect its contractual obligations entered into pursuant to Article V paragraph B or its financial obligations for the year in which it withdraws.

The Agency will strive that companies will provide to all shareholders the possibility of informed and unhampered decision-making, not only with regard to matters for which this is urgently required by the law but also in all other matters which might significantly influence their interests.

The Republic of Slovenia shall designate a Managing Authority which, without prejudice to Section A, shall be responsible for the efficiency and correctness of co-ordination and reporting on the monitoring and evaluation of the Programme. The Managing Authority shall consult the SAPARD Agency on all issues relating to implementation.

The European Food Safety Authority can make an important contribution to underpinning proposed actions on nutrition (e. g. on recommended nutrient intakes, or on communication strategies aimed at health professionals, food chain operators and the general public on the impact of nutrition on health) with scientific advice and assistance ( on the role of EFSA in the establishment of food-based dietary guidelines, cf section V.9 below).

and which accept this Agreement in accordance with the provisions of Article XIII below, it being understood that these provisions shall not affect the membership status in the Commission of such States that are not members of the United Nations, any of its Specialized Agencies or the International Atomic Energy Agency as may have become parties to this Agreement prior to 22 May 1963. As regards Associate Members, this Agreement shall, in accordance with the provisions of Article XIV.5 of the Constitution and Rule XXI.3 of the General Rules of the Organization, be submitted by the Organization to the authority having responsibility for the international relations of such Associate Members.

(b) in the case of sabotage of nuclear material or a nuclear facility in a State Party and if in its view other States are likely to be radiologically affected, the former, without prejudice to its other obligations under international law, shall take appropriate steps to inform as soon as possible the State or the States which are likely to be radiologically affected and to inform, where appropriate, the International Atomic Energy Agency and other relevant international organizations, with a view to minimizing or mitigating the radiological consequences thereof;

This Regulation shall not affect the competences vested in the European Food Safety Authority created by Regulation (EC) No 178/2002(23).

To mitigate the effects of harvest fluctuations on the balance between supply and demand and in this way to stabilise consumer prices, the Council, acting in accordance with the voting procedure laid down in Article 43 (2) of the Treaty on a proposal from the Commission, may require intervention agencies to form a buffer stock of olive oil.

In particular, he shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product for human use concerned.

It is appropriate to provide for a simplified and rapid notification procedure to enable the introduction of certain minor changes, which do not affect the approved quality, safety or efficacy of the product, without prior evaluation by the European Agency for the evaluation of medicinal products (hereinafter referred to as "the Agency").

(4) It is appropriate to provide for a simplified and rapid notification procedure to enable the introduction of certain minor changes, which do not affect the approved quality, safety or efficacy of the product, without prior evaluation by the European Agency for the evaluation of medicinal products (hereinafter referred to as "the Agency").

In particular the aforementioned person shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the veterinary medicinal product concerned.

further develop the National Development Plan and the Rural Development Plan; adopt the legal, administrative and budgetary framework (audit manual and audit trail) to programme and manage ISPA and Sapard, including the introduction of environmental impact assessments and European Union compatible public procurement rules for projects co-financed by Community Funds; establish a functioning paying agency for Sapard,

further develop the National Development Plan and the Rural Development Plan; adopt the legal, administrative and budgetary framework (audit manual and audit trail) to programme and manage ISPA and Sapard, including a mechanism for systematic environmental impact assessment and European Union-compatible public procurement rules for projects co-financed by Community Funds; and the establishment of a functioning paying agency for Sapard,

Each area, system, part or appliance that the Agency finds is not affected by the change.

This Regulation shall not affect the competences vested in the European Food Safety Authority created by Regulation (EC) No 178/2002(23).

It establishes the European Food Safety Authority. It lays down procedures for matters with a direct or indirect impact on food and feed safety.

The Agency’ s mandate to provide opinions on medicinal products intended for use exclusively in markets outside the EU (cooperation with the WHO) will have an impact on the scope of the certification scheme. Similarly, the provision of certificates free

The revenue of the Agency shall, without prejudice to other resources, consist of a subsidy from the Community entered in the general budget of the European Communities and payments for services rendered.

A decision of the European Environment Agency which may adversely affect the rights or interests of a private person shall contain an indication of the appeal possibilities available for challenging the decision.

Without prejudice to Article 17(4), storage contracts to be concluded prior to buying in between parties making offers and the intervention agency shall be concluded for an indefinite period.

The activities of the European Maritime Safety Agency may affect the level of maritime safety and prevention of pollution by ships within the European Economic Area.

The provision of scientific advice is one of the most important ways in which the Agency can support innovation and research: analysis of the impact of scientific advice provided by the Agency shows that the procedure significantly increases the chances of obtaining a marketing authorisation.

Without prejudice to the provisions of this Regulation or of Regulation (EEC) No 2309/93, the Agency's Management Board may, on a proposal from the Executive Director, specify any other provision proving necessary for the application of this Regulation.

The preceding Articles do not prejudice the question of ships employed on the official service of the United Nations, its specialised agencies or the International Atomic Energy Agency, flying the flag of the organisation.

Every decision of the European Environment Agency which may adversely affect the rights or interests of a private person shall state the grounds on which it is based by indicating clearly the relevant facts and the legal basis of the decision.

• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached

Each area, system, part or appliance that is affected by the change, for which the Agency finds that compliance with an airworthiness code described in paragraph (a) would not contribute materially to the level of safety of the changed product or would be impractical.

The Commission shall consult the European Food Safety Authority on any matter within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing Community targets in accordance with Article 4 or specific control methods in accordance with Article 8.

• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.

Whereas it is therefore appropriate to establish a European Agency for Safety and Health at Work responsible for assisting, inter alia, the Commission in carrying out tasks in the field of safety and health at work and, in that context, for contributing to the development of future Community action programmes relating to the protection of safety and health at work, without prejudice to the Commission's sphere of competence;

In addition, an updated RMP should be submitted: − When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities. − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached. − At the request of the EMEA.

The Commission shall consult the European Food Safety Authority on any matter within the scope of this Directive that could have a significant impact on public health, in particular before proposing any amendment to Annexes I or II or before establishing any coordinated monitoring programme in accordance with Article 5.

In accordance with the approach followed for the reform of the common organisation of the markets in connection with Agenda 2000 and in order to enable producers to work out longer-term production plans, the basic price should be fixed without any limit in time, without prejudice to any revisions that may be called for in the future.

Without prejudice to the other provisions of this Regulation or of Regulation (EEC) No 2309/93, implementing rules adopted by the Agency's Management Board shall lay down the due date for fees to paid under Article 1, the methods of their payment, the consequences of belated payment or non-payment and any other measure needed to apply this Regulation.

In particular, he shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product for human use concerned.

In accordance with the approach followed for the reform of the common organisation of the markets in connection with Agenda 2000 and in order to enable producers to organise their production over several years, the number and amount of the monthly increases should be fixed without any limit in time, without prejudice to any revisions that may be called for in the future.

In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA

In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.

22 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA

• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA

In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached

In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 says of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.

and which accept this Agreement in accordance with the provisions of Article XI below, it being understood that these provisions shall not affect the membership status in the Commission of such States that are not members of the United Nations, any of its Specialised Agencies or the International Atomic Energy Agency as may have become parties to this Agreement prior to 22 May 1963.

32 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA

In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA

To this end, the Agency will: conduct self-assessment activities as part of the EU benchmarking system, alongside its European partners; review the level of implementation of the internal control standards; conduct annual management-review activities; assess its achievements in the area of risk management; and assess the impact of improvements following audits.

In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached, At the request of the EMEA.

In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.