The Commission has proposed a new framework(29), which will ensure that public transport operators are under competitive pressure to offer passengers better services, keep costs under control and ensure the highest safety level.

To subject these substances to the same strict controls as those listed in Annex I would present an unnecessary obstacle to trade involving licences to operate and documentation of transactions.

Member States may conclude an agreement on the supervision provided for in this Article with regard to the air navigation service provider providing services in a Member State other than that in which the provider has its principal place of operation.

Member States are responsible for monitoring the safe and efficient provision of air navigation services and for the control of compliance by air navigation service providers with the common requirements established at Community level.

It is also necessary to take measures for the supervision of medicinal products authorised by the Community, and in particular for the intensive supervision of undesirable effects of these medicinal products within the framework of Community pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any medicinal product presenting a negative risk-benefit balance under normal conditions of use.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004

Certificates may be issued individually for each type of air navigation service as defined in Article 2 of the framework Regulation, or for a bundle of such services, inter alia, where a provider of air traffic services, whatever its legal status, operates and maintains its own communication, navigation and surveillance systems.

Before a system is put into service, the relevant air navigation service provider shall establish an EC declaration of verification, confirming compliance, and shall submit it to the national supervisory authority together with a technical file.

The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as "the Agency").

Where consignments of products have received veterinary clearance at the border inspection post as provided for in Article 3(1), but remain under customs supervision and are released for free circulation at a later stage, the procedure set out in paragraphs 2, 3 and 4 shall apply.

Expenditure on traffic police comprises the total expenditure of police services chargeable to their traffic supervision and control functions, including expenditure on buildings, vehicles and equipment for the special use of such services.

The supervisory authorities shall be responsible for verifying on behalf of the Community that the holder of the marketing authorisation for the veterinary medicinal product or the manufacturer or importer established within the Community satisfies the requirements laid down in Titles IV, VII and VIII of Directive 2001/82/EC.

The supervisory authorities shall be responsible for verifying on behalf of the Community that the holder of the marketing authorisation for the medicinal product for human use or the manufacturer or importer established within the Community satisfies the requirements laid down in Titles IV, IX and XI of Directive 2001/83/EC.

Whereas Article 82 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(10), as last amended by Regulation (EC) No 82/97(11), provides for customs supervision of goods released for free circulation at a reduced rate of duty on account of their end-use;

coordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose;

Furthermore, the Member State concerned may also provide for ad hoc derogations for certain quality wines psr as referred to in the second indent of Article 29(1)(b) of this Regulation and aged in bottles for a long period before sale, provided that they lay down control requirements and rules for circulation for those products.

They may also include costs incurred by national supervisory authorities and/or recognised organisations, as well as other costs incurred by the relevant Member State and service provider in relation to the provision of air navigation services;

(2) Notwithstanding the provision of the first paragraph hereunder, the Insurance Supervision Agency shall refuse to grant an authorisation to perform insurance business in the section relating to compulsory insurance in transport or supplementary health insurance if general or special policy conditions are in contravention of the act regulating compulsory insurance in transport or supplementary health insurance.

Neither the national supervisory authorities, acting in accordance with their national legislation, nor the Commission shall disclose information of a confidential nature, in particular information about air navigation service providers, their business relations or their cost components.

The provisions of this Regulation shall, in the field of transport by rail, road and inland waterway, apply both to all agreements, decisions and concerted practices which have as their object or effect the fixing of transport rates and conditions, the limitation or control of the supply of transport, the sharing of transport markets, the application of technical improvements or technical co-operation, or the joint financing or acquisition of transport equipment or supplies where such operations are directly related to the provision of transport services and are necessary for the joint operation of services by a grouping within the meaning of Article 4 of road or inland waterway transport undertakings, and to the abuse of a dominant position on the transport market.

"Furthermore, the Member State concerned may provide for ad hoc derogations for certain quality wines psr and quality sparkling wines psr as referred to in Article 29 aged in bottles for a long period before sale, provided that they lay down control requirements and rules for circulation for those products.

The chief task of the Agency should be to provide Community institutions and Member States with the best possible scientific opinions so as to enable them to exercise the powers regarding the authorisation and supervision of medicinal products conferred on them by Community legislation in the field of medicinal products.

In the public sector, calculation of the turnover of an undertaking concerned in a concentration needs, therefore, to take account of undertakings making up an economic unit with an independent power of decision, irrespective of the way in which their capital is held or of the rules of administrative supervision applicable to them.

(5) Notwithstanding the provision of the first paragraph hereunder, the Member State insurance undertaking may start to perform compulsory insurance in transport when it submits to the Insurance Supervision Agency a document, to be issued by the Slovene Insurance Association, stating that the Member State insurance undertaking in question:

Nothing in these provisions shall affect the right of Member States to take such measures as they consider necessary for the purpose of controlling immigration from third countries, and to combat terrorism, crime, the traffic in drugs and illicit trading in works of art and antiques.

Owing to the particular sensitivity of information concerning air navigation service providers, national supervisory authorities should not disclose information covered by the obligation of professional secrecy, without prejudice to the organisation of a system for monitoring and publishing the performance of those providers,

(6) Notwithstanding the provision of the first paragraph hereunder, the Member State insurance undertaking may only start to perform compulsory insurance in transport or supplementary health insurance if it obtains an approval from the Insurance Supervision Agency concerning the general and special policy conditions with regard to these insurances.

To ensure an appropriate level of transparency, the Management Board, on the basis of a proposal by the Executive Director and in agreement with the Commission, shall adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature.

a proposal for post-market monitoring regarding the use of the food for human consumption or the feed for animal consumption, as provided for in Article 5(3)(k) and Article 17(3)(k) of Regulation (EC) No 1829/2003, and according to the characteristics of the products concerned, or a verifiable justification to the effect that a post-market monitoring is not necessary. 2. Points (a), (b) and (c) of paragraph 1 shall not apply to applications concerning only food and feed produced from GMOs or containing ingredients produced from GMOs. Article 4 1.

Paragraph 1 shall be without prejudice to the right of disclosure by national supervisory authorities where it is essential for the purposes of fulfilling their duties, in which case such disclosure shall be proportionate and shall have regard to the legitimate interests of air navigation service providers in the protection of their business secrets.

The national supervisory authorities referred to in Article 4 of the framework Regulation shall ensure the appropriate supervision of the application of this Regulation, in particular with regard to the safe and efficient operation of air navigation service providers which provide services relating to the airspace falling under the responsibility of the Member State which nominated or established the relevant authority.

Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions.

With regard to the placing on the market and export of animal by-products intended for a technical use produced in the Community, the rules laid down in Regulation (EC) No 1774/2002 should be generally sufficient, subject to complementing the rules for collection and transport to ensure the strict channelling, identification, and control objectives being pursued;

the first group of TSIs shall cover control/command and signalling; telematic applications for freight services; traffic operation and management (including staff qualifications for cross-border services respecting the criteria defined in Annexes II and III); freight wagons; noise problems deriving from rolling stock and infrastructure.

Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions.

for the surveillance of airspace that is under its responsibility in accordance with ICAO Regional Air Navigation agreements, including the capability to detect, identify and evaluate all aircraft using such airspace, with a view to seeking to safeguard safety of flights and to take action to ensure security and defence needs,

Where independent audits are required relating to providers of air navigation services, inspections by the official auditing authorities of the Member States where those services are provided by the administration, or by a public body subject to the supervision of the abovementioned authorities, should be recognised as independent audits, whether the audit reports drawn up are made public or not.

In the future, periodic verification of the correct functioning of the speed limiter will be facilitated for the vehicles that are fitted with the new recording equipment (digital tachograph) according to Council Regulation (EC) No 2135/98 of 24 September 1998 amending Regulation (EEC) No 3821/85 on recording equipment in road transport and Directive 88/599/EEC concerning the application of Regulations (EEC) No 3820/85 and (EEC) No 3821/85(4).

Surveillance systems shall be designed, built, maintained and operated using appropriate and validated procedures in such a way as to provide the required performance applicable in a given environment (surface, TMA, en-route) with known traffic characteristics and exploited under an agreed and validated operational concept, in particular in terms of accuracy, coverage, range and quality of service.

Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(4) provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.

At the competent authority's request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(12).

Whereas Council Regulation No 141 3 exempting transport from the application of Regulation No 17 provides that the said Regulation No 17 4 shall not apply to agreements, decisions and concerted practices in the transport sector the effect of which is to fix transport rates and conditions, to limit or control the supply of transport or to share transport markets, nor to dominant positions, within the meaning of Article 86 of the Treaty, on the transport market;

In order to limit the time and expense involved in complying with various merger control procedures in several individual countries, the European Union has put in place a system of merger control by which concentrations having a Community dimension (normally, where the parties to the concentration fulfil certain turnover thresholds)(2) are assessed by the European Commission in a single procedure (the "one stop shop" principle).

The release for free circulation in one of the 10 new Member States acceding to the European Union on 1 May 2004, namely Czech Republic, Estonia, Cyprus, Lithuania, Latvia, Hungary, Malta, Poland, Slovenia and Slovakia, of textile products which are subject to quantitative limits or to surveillance in the Community and which have been shipped before 1 May 2004 and enter the 10 new Member States on or after 1 May 2004 shall be subject to presentation of an import authorisation.

Surveillance data processing systems shall be designed, built, maintained and operated using the appropriate and validated procedures, in such a way as to provide the required performance and quality of service within a given environment (surface, TMA, en-route) with known traffic characteristics, in particular in terms of accuracy and reliability of computed results, correctness, integrity, availability, continuity and timeliness of information at the control position.

For reasons of legal certainty, it should be specified that this entity, which is not designed to fulfil an economic purpose and is responsible for managing a public research programme of European interest, must be considered as an international organisation within the meaning of the second indent of Article 15(10) of the Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes(9) and the second indent of Article 23(1) of Council Directive 92/12/EEC of 25 February 1992 on the general arrangements for products subject to excise duty and on the holding, movement and monitoring of such products(10).

MONITORING OF PLACING ON THE MARKET

Traffic - control services

Surveillance systems

surveillance systems,