In accordance with Articles 2 et seq. of Annex 7, authorisation shall be required for special regular services not covered, on Community territory, by a contract concluded between the organiser and the carrier.

The provisions of this Directive shall not prejudice the application of national laws which provide for special supplementary authorisations permitting credit institutions to carry on specific activities or undertake specific kinds of operations.

In the interests of clarity and in order to comply with Article 12(10) of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 19 December 1988, and with Resolution 20/4 of the 1998 Special Session on drugs of the United Nations General Assembly, the provisions on export authorisation for the scheduled substances listed in Category 1 of the Annex to Regulation (EEC) No 3677/90 should be separated from those on pre-export notification.

(2) In the interests of clarity and in order to comply with Article 12(10) of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 19 December 1988, and with Resolution 20/4 of the 1998 Special Session on drugs of the United Nations General Assembly, the provisions on export authorisation for the scheduled substances listed in Category 1 of the Annex to Regulation (EEC) No 3677/90 should be separated from those on pre-export notification.

Whereas it is appropriate that the Council should authorise the Commission, in consultation with a special committee appointed by the Council, to approve amendments on behalf of the Community where the Agreement provides for them to be adopted by the Joint Follow-up Group; whereas such authorisation must, however, be limited to the amendment of the Annexes to the Agree ment in so far as such amendment concerns substances already covered by Community legislation on drugs precursors and chemical substances,

(2) However, point D.2 of that Annex provides that, until 31 August 2003 at the latest, in the case of a traditional practice governed by special provisions of the Member State of production, that Member State may permit on certain conditions, by means of express authorisations and subject to suitable controls, that a quality sparkling wine psr be obtained by adding to the basic product from which the wine is made one or more wine-sector products which do not originate in the specified region whose name the wine bears.

(2) Taking the view that more time was needed to bring the taxes applied to manufactured tobaccos in Corsica into line with the taxes applicable on the mainland, France requested, in particular, in a memorandum dated 26 July 2000 pleading recognition of Corsica's special position as an island within the European Union ("Pour une reconnaissance de la spécificité insulaire de la Corse dans l'Union européenne"), authorisation to prolong until 31 December 2009 the application of certain tax rules derogating from the Community's requirements regarding the taxation of tobacco products.

The first subparagraph of Annex VI.D.2 to Regulation (EC) No 1493/1999 is hereby replaced by the following:"As an exception to paragraph 1(a), in the case of a traditional practice governed by special provisions of the Member State of production, that Member State may until 31 August 2005 at the latest, by means of express authorisations and subject to suitable controls, permit that a quality sparkling wine psr be obtained by adding to the basic product from which the wine is made one or more wine-sector products which do not originate in the specified region whose name the wine bears, provided that:"

Second paragraph of Article 2 of the Law of 15 February 1917, as amended and supplemented by Décret-loi of 30 October 1935, which requires that special authorisation be obtained;

Applications for authorisation of regular services and special regular services subject to authorisation shall conform to the model in Annex III.

whereas therefore no company or firm may be required, in order to obtain the benefit of such measures, to fulfil any additional condition, and in particular no company or firm may be required to obtain any special authorisation not required of a domestic company or firm wishing to pursue a particular economic activity;

the identification of those hazardous activities which require special preventive measures, which may include a licensing or authorisation system;

Whereas Article 4(4) of Regulation (EEC) No 684/92 provides that regular services and certain special regular services are to be subject to authorisation;

between the European Community and the Macao Special Administrative Region of the People's Republic of China on the readmission of persons residing without authorisation

between the European Community and the Government of the Hong Kong Special Administrative Region of the People's Republic of China on the readmission of persons residing without authorisation

The data group shall be used if an authorised consignor lodges a declaration for which his authorisation requires the use of seals or a principal is granted the use of seals of a special type.

General information on special requirements and conditions to which the hazardous activity is subject according the relevant national regulations and/or administrative provisions, including licensing or authorisation systems;

whereas Member States should be able to include in the authorisations an obligation that the authorised activities must not infringe the exclusive or special rights granted to the universal service providers for the reserved services;

The Commission has negotiated on behalf of the European Community an Agreement with the Government of the Hong Kong Special Administrative Region of the People's Republic of China on the readmission of persons residing without authorisation.

kind of entitlement, in particular set-aside entitlements, entitlements subject to special conditions in accordance with Article 48 of Regulation (EC) No 1782/2003, and entitlements with authorisation in accordance with Article 60 of that Regulation;

The Agreement between the European Community and the Government of the Hong Kong Special Administrative Region of the People's Republic of China on the readmission of persons residing without authorisation is hereby approved on behalf of the European Community.

Council Decision of 17 December 2003 concerning the conclusion of the Agreement between the European Community and the Government of the Hong Kong Special Administrative Region of the People's Republic of China on the readmission of persons residing without authorisation

Such authorisation shall be subject to the condition that the authorised consignor has previously given those authorities a written undertaking acknowledging his liability for the legal consequences arising from all T2L documents or commercial documents issued bearing the special stamp.

The CVMP concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided that the product is used under the conditions agreed, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

The Directive should therefore take account of the special position of trials whose planning does not require particular manufacturing or packaging processes, if these trials are carried out with medicinal products with a marketing authorisation within the meaning of Directive 65/65/EEC, manufactured or imported in accordance with the provisions of Directives 75/319/EEC and 91/356/EEC, and on patients with the same characteristics as those covered by the indication specified in this marketing authorisation.

With a view to taking into account further developments in the financial markets the Commission should submit reports to the European Parliament and the Council on the application of the provisions concerning professional indemnity insurance, the scope of the transparency rules and the possible authorisation of specialised dealers in commodity derivatives as investment firms.

It was therefore concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

It is concluded from the above evaluation that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

Without prejudice to paragraph 6, written authorisation may be required before the commencement of clinical trials for such trials on medicinal products which do not have a marketing authorisation within the meaning of Directive 65/65/EEC and are referred to in Part A of the Annex to Regulation (EEC) No 2309/93, and other medicinal products with special characteristics, such as medicinal products the active ingredient or active ingredients of which is or are a biological product or biological products of human or animal origin, or contains biological components of human or animal origin, or the manufacturing of which requires such components.

Implement and strengthen the European risk-management strategy in close cooperation with the Member States; Fully apply tools provided by the new legislation, including risk-management plans and specialised studies on safety profiles of medicinal products post authorisation; Work to establish a network for intensive monitoring of targeted medicines; Full integration of the pharmacovigilance network between EU regulatory bodies.

For species of special importance in the region defined in Annex II which are biologically sensitive by reason of their exploitation characteristics, fishing activity by Community fishing vessels of a length between the perpendiculars of not less than 26 metres, for demersal species other than Norway pout and blue whiting, shall be governed by a system of prior authorisation in accordance with the conditions laid down in this Regulation and, in particular, in Annex II.

However, point D.2 of that Annex provides that, until 31 August 2003 at the latest, in the case of a traditional practice governed by special provisions of the Member State of production, that Member State may permit on certain conditions, by means of express authorisations and subject to suitable controls, that a quality sparkling wine psr be obtained by adding to the basic product from which the wine is made one or more wine-sector products which do not originate in the specified region whose name the wine bears.

The marketing authorisation may require the holder to indicate on the immediate packaging and/or the outer wrapping and the package leaflet, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Article 12(3)(j) and in Articles 13 to 13d or from experience gained during the use of the veterinary medicinal product once it has been marketed.".

The assessment of the risk presented by toltrazuril sulfone to terrestrial plants and to groundwater demonstrated that the use of products containing toltrazuril is acceptable and the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

Taking the view that more time was needed to bring the taxes applied to manufactured tobaccos in Corsica into line with the taxes applicable on the mainland, France requested, in particular, in a memorandum dated 26 July 2000 pleading recognition of Corsica's special position as an island within the European Union ("Pour une reconnaissance de la spécificité insulaire de la Corse dans l'Union européenne"), authorisation to prolong until 31 December 2009 the application of certain tax rules derogating from the Community's requirements regarding the taxation of tobacco products.

To forestall the proliferation of specific arrangements applicable to certain sectors only, the current special arrangements created by Article 3 of Directive 93/38/EEC and Article 12 of Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons(13) governing entities exploiting a geographical area for the purpose of exploring for or extracting oil, gas, coal or other solid fuels should be replaced by the general procedure allowing for exemption of sectors directly exposed to competition.

it is therefore necessary to include in national law appropriate effective and systematic financial or equivalent administrative penalties - such as injunctions combined with administrative fines, reporting to supervisory authorities on a regular basis, on-the-spot checks, publications in the national official journal and in the press, suspension of the activities of the company (prohibition on the conclusion of new contracts for a certain period), designation of a special representative of the supervisory authorities responsible for monitoring that the business is run in line with insurance laws, withdrawal of the authorisation for this business line, sanctions to be imposed on directors and management staff - in the event that the insurance undertaking or its representative fails to fulfil its obligation to make an offer of compensation within a reasonable time-limit;