ISSN 1725-2423

Official Journal

of the European Union

C 245

European flag  

English edition

Information and Notices

Volume 51
26 September 2008


Notice No

Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

 

Commission

2008/C 245/01

Euro exchange rates

1

2008/C 245/02

Guidelines on the application of Article 81 of the EC Treaty to maritime transport services ( 1 )

2

2008/C 245/03

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )

15

2008/C 245/04

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )

21

 

V   Announcements

 

ADMINISTRATIVE PROCEDURES

 

Commission

2008/C 245/05

Call for expressions of interest in membership in the scientific risk assessment Advisory Structure of Scientific Committees and database of experts

23

 

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

 

Commission

2008/C 245/06

Prior notification of a concentration (Case COMP/M.5251 — System Capital Management-Energies/Metinvest) — Candidate case for simplified procedure ( 1 )

26

2008/C 245/07

Prior notification of a concentration (Case COMP/M.5178 — OEP/Pfleiderer) — Candidate case for simplified procedure ( 1 )

27

 

Corrigenda

2008/C 245/08

Corrigendum to Commission notice pursuant to Article 4(1)(a) of Council Regulation (EEC) No 2408/92 — Modification by Italy of the public service obligation in respect of the scheduled air service between Pantelleria-Trapani (OJ C 230, 9.9.2008)

28

 

2008/C 245/09

Note to the reader(see page 3 of the cover)

s3

 


 

(1)   Text with EEA relevance

EN

 


IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

26.9.2008   

EN

Official Journal of the European Union

C 245/1


Euro exchange rates (1)

25 September 2008

(2008/C 245/01)

1 euro=

 

Currency

Exchange rate

USD

US dollar

1,47

JPY

Japanese yen

155,91

DKK

Danish krone

7,46

GBP

Pound sterling

0,792

SEK

Swedish krona

9,6829

CHF

Swiss franc

1,5944

ISK

Iceland króna

137,29

NOK

Norwegian krone

8,271

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

24,414

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

240,75

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7085

PLN

Polish zloty

3,3395

RON

Romanian leu

3,6829

SKK

Slovak koruna

30,29

TRY

Turkish lira

1,8178

AUD

Australian dollar

1,7491

CAD

Canadian dollar

1,5205

HKD

Hong Kong dollar

11,4253

NZD

New Zealand dollar

2,1372

SGD

Singapore dollar

2,0895

KRW

South Korean won

1 691,24

ZAR

South African rand

11,9893

CNY

Chinese yuan renminbi

10,021

HRK

Croatian kuna

7,122

IDR

Indonesian rupiah

13 777,58

MYR

Malaysian ringgit

5,0377

PHP

Philippine peso

68,27

RUB

Russian rouble

36,722

THB

Thai baht

49,862

BRL

Brazilian real

2,7235

MXN

Mexican peso

15,9172


(1)  

Source: reference exchange rate published by the ECB.


26.9.2008   

EN

Official Journal of the European Union

C 245/2


Guidelines on the application of Article 81 of the EC Treaty to maritime transport services

(Text with EEA relevance)

(2008/C 245/02)

1.   INTRODUCTION

1.

These Guidelines set out the principles that the Commission of the European Communities will follow when defining markets and assessing cooperation agreements in those maritime transport services directly affected by the changes brought about by Council Regulation (EC) No 1419/2006 of 25 September 2006, i.e. liner shipping services, cabotage and international tramp services (1).

2.

These Guidelines are intended to help undertakings and associations of undertakings operating those services, mainly if operated to and/or from a port or ports in the European Union, to assess whether their agreements (2) are compatible with Article 81 of the Treaty establishing the European Community (hereinafter ‘the Treaty’). The Guidelines do not apply to other sectors.

3.

Regulation (EC) No 1419/2006 extended the scope of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (3) and Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the Treaty (4) to include cabotage and tramp vessel services. Consequently, as of 18 October 2006, all maritime transport services sectors are subject to the generally applicable procedural framework.

4.

Regulation (EC) No 1419/2006 also repealed Council Regulation (EEC) No 4056/86 of 22 December 1986 on the application of Articles 85 and 86 (now 81 and 82) of the Treaty to maritime transport (5) containing the liner conference block exemption which allowed shipping lines meeting in liner conferences to fix rates and other conditions of carriage, as the conference system no longer fulfils the criteria of Article 81(3) of the Treaty. The repeal of the block exemption takes effect as of 18 October 2008. Thereafter, liner carriers operating services to and/or from one or more ports in the European Union must cease all liner conference activity contrary to Article 81 of the Treaty. This is the case regardless of whether other jurisdictions allow, explicitly or tacitly, rate fixing by liner conferences or discussion agreements. Moreover, conference members should ensure that any agreement taken under the conference system complies with Article 81 as of 18 October 2008.

5.

These Guidelines complement the guidance already issued by the Commission in other notices. As maritime transport services are characterised by extensive cooperation agreements between competing carriers, the Guidelines on the applicability of Article 81 of the Treaty to horizontal cooperation agreements (6) (the Guidelines on Horizontal Cooperation) and the Guidelines on the application of Article 81(3) of the Treaty (7) are particularly relevant.

6.

Horizontal cooperation agreements in liner shipping regarding the provision of joint services are covered by Commission Regulation (EC) No 823/2000 of 19 April 2000 on the application of Article 81(3) of the Treaty to certain categories of agreements, decisions and concerted practices between liner shipping companies (consortia) (8). It sets out the conditions, pursuant to Article 81(3) of the Treaty, under which the prohibition in Article 81(1) of the Treaty does not apply to agreements between two or more vessel operating carriers (consortia). It will be reviewed following the changes introduced by Regulation (EC) No 1419/2006 (9).

7.

These Guidelines are without prejudice to the interpretation of Article 81 of the Treaty which may be given by the Court of Justice or the Court of First Instance of the European Communities. The principles in the Guidelines are to be applied in the light of the circumstances specific to each case.

8.

The Commission will apply these Guidelines for a period of five years.

2.   MARITIME TRANSPORT SERVICES

2.1.   Scope

9.

Liner shipping services, cabotage and tramp services are the maritime transport sectors directly affected by the changes brought about by Regulation (EC) No 1419/2006.

10.

Liner shipping involves the transport of cargo, chiefly by container, on a regular basis to ports of a particular geographic route, generally known as a trade. Other general characteristics of liner shipping are that timetables and sailing dates are advertised in advance and services are available to any transport user.

11.

Article 1(3)(a) of Regulation (EEC) No 4056/86 defined tramp vessel services as the transport of goods in bulk or in break bulk in a vessel chartered wholly or partly to one or more shippers on the basis of a voyage or time charter or any other form of contract for non-regularly scheduled or non-advertised sailings where the freight rates are freely negotiated case by case in accordance with the conditions of supply and demand. It is mostly the unscheduled transport of one single commodity which fills a vessel (10).

12.

Cabotage involves the provision of maritime transport services including tramp and liner shipping, linking two or more ports in the same Member State (11). Although these Guidelines do not specifically address cabotage services they nevertheless apply to these services insofar as they are provided either as liner or tramp shipping services.

2.2.   Effect on trade between Member States

13.

Article 81 of the Treaty applies to all agreements which may appreciably affect trade between Member States. In order for there to be an effect on trade it must be possible to foresee with a sufficient degree of probability on the basis of a set of objective factors of law or fact that the agreement or conduct may have an influence, direct or indirect, actual or potential, on the pattern of trade between Member States (12). The Commission has issued guidance on how it will apply the concept of affectation of trade in its Guidelines on the effect of trade concept contained in Articles 81 and 82 of the Treaty (13).

14.

Transport services offered by liner shipping and tramp operators are often international in nature linking Community ports with third countries and/or involving exports and imports between two or more Member States (i.e. intra Community trade (14)). In most cases they are likely to affect trade between Member States inter alia on account of the impact they have on the markets for the provision of transport and intermediary services (15).

15.

Effect on trade between Member States is of particular relevance to maritime cabotage services since it determines the scope of application of Article 81 of the Treaty and its interaction with national competition law under Article 3 of Regulation (EC) No 1/2003 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty. The extent to which such services may affect trade between Member States must be evaluated on a case by case basis (16).

2.3.   The relevant market

16.

In order to assess the effects on competition of an agreement for the purposes of Article 81 of the Treaty, it is necessary to define the relevant product and geographic market(s). The main purpose of market definition is to identify in a systematic way the competitive constraints faced by an undertaking. Guidance on this issue can be found in the Commission Notice on the definition of the relevant market for the purposes of Community competition law (17). This guidance is also relevant to market definition as regards maritime transport services.

17.

The relevant product market comprises all those products and/or services which are regarded as interchangeable or substitutable by the consumer, by reason of the products' characteristics, their prices and their intended use. The relevant geographic market comprises the area in which the undertakings concerned are involved in the supply and demand of products or services, in which the conditions of competition are sufficiently homogeneous and which can be distinguished from neighbouring areas because the conditions of competition are appreciably different in those areas (18). A carrier (or carriers) cannot have a significant impact on the prevailing conditions of the market if customers are in a position to switch easily to other service providers (19).

2.3.1.   Liner shipping

18.

Containerised liner shipping services have been identified as the relevant product market for liner shipping in several Commission decisions and Court judgments (20). Those decisions and judgments related to maritime transport in deep sea trades. Other modes of transport have not been included in the same service market even though in some cases these services may be, to a marginal extent, interchangeable. This was because only an insufficient proportion of the goods carried by container can easily be switched to other modes of transport, such as air transport services (21).

19.

It may be appropriate under certain circumstances to define a narrower product market limited to a particular type of product transported by sea. For example, the transport of perishable goods could be limited to reefer containers or include transport in conventional reefer vessels. While it is possible in exceptional circumstances for some substitution to take place between break bulk and container transport (22), there appears to be no lasting change over from container towards bulk. For the vast majority of categories of goods and users of containerised goods, break bulk does not offer a reasonable alternative to containerised liner shipping (23). Once cargo becomes regularly containerised it is unlikely ever to be transported again as non-containerised cargo (24). To date containerised liner shipping is therefore mainly subject to one way substitutability (25).

20.

The relevant geographic market consists of the area where the services are marketed, generally a range of ports at each end of the service, determined by ports' overlapping catchment areas. As far as the European end of the service is concerned, to date the geographical market in liner cases has been identified as a range of ports in Northern Europe or in the Mediterranean. As liner shipping services from the Mediterranean are only marginally substitutable for those from Northern European ports, these have been identified as separate markets (26).

2.3.2.   Tramp services

21.

The Commission has not yet applied Article 81 of the Treaty to tramp shipping. Undertakings may consider the following elements in their assessment inasmuch as they are relevant to the tramp shipping services they provide.

Elements to take into account when determining the relevant product market from the demand side (demand substitution)

22.

The ‘main terms’ of an individual transport request are a starting point for defining relevant service markets in tramp shipping since they generally identify the essential elements (27) of the transport requirement at issue. Depending on the transport users' specific needs, they will be made up of negotiable and non-negotiable elements. Once identified, a negotiable element of the main terms, for example the vessel type or size, may indicate, for instance, that the relevant market with respect to this specific element is wider than laid down in the initial transport requirement.

23.

The nature of the service in tramp shipping may differ and there is a variety of transport contracts. It may be necessary, therefore, to ascertain whether the demand side considers the services provided under time charter contracts, voyage charter contracts and contracts of affreightment to be substitutable. Should this be the case they may belong to the same relevant market.

24.

Vessel types are usually subdivided into a number of standard industrial sizes (28). Due to considerable economies of scale, a service with a significant mismatch between cargo volume and vessel size may not be able to offer a competitive freight rate. Therefore, the substitutability of different vessel sizes needs to be assessed case by case so as to ascertain whether each vessel size constitutes a separate relevant market.

Elements to take into account when determining the relevant product market from the supply-side (supply substitution)

25.

The physical and technical conditions of the cargo to be carried and the vessel type provide the first indications as to the relevant market from the supply side (29). If vessels can be adjusted to transport a particular cargo at negligible cost and in a short time-frame (30), different tramp shipping service providers are able to compete for the transport of this cargo. In such circumstances, the relevant market from the supply side will comprise more than one type of vessel.

26.

However, there are a number of vessel types that are technically adapted and/or specially built to provide specialised transport services. Although specialised vessels may also carry other types of cargo, they may be at a competitive disadvantage. The ability of specialised service providers to compete for the transport of other cargo may, therefore, be limited.

27.

In tramp shipping, port calls are made in response to individual demand. Mobility of vessels may however be limited by terminal and draught restrictions or environmental standards for particular vessel types in certain ports or regions.

Additional considerations to take into account when determining the relevant product market

28.

The existence of chains of substitution between vessel sizes in tramp shipping should also be considered. In certain tramp shipping markets, vessel sizes at the extreme of the market are not directly substitutable. Chain substitution effects may nevertheless constrain pricing at the extremes and lead to their inclusion in a broader market definition.

29.

In certain tramp shipping markets, consideration must be given to whether vessels can be considered as captive capacity and should not be taken into account when assessing the relevant market on a case by case basis.

30.

Additional factors such as the reliability of the service provider, security, safety and regulatory requirements may influence supply and demand-side substitutability, for example the double hull requirement for tankers in Community waters (31).

Geographic dimension

31.

Transport requirements usually contain geographic elements such as the loading and discharging ports or regions. These ports provide the first orientation for the definition of the relevant geographic market from the demand-side, without prejudice to the final definition of the relevant geographic market.

32.

Certain geographic markets may be defined on a directional basis or may occur only temporarily for instance when climatic conditions or harvest periods periodically affect the demand for transport of particular cargos. In this context, repositioning of vessels, ballast voyages and trade imbalances should be considered for the delineation of relevant geographic markets.

2.4.   Market shares

33.

Market shares provide useful first indications of the market structure and of the competitive importance of the parties and their competitors. The Commission interprets market shares in the light of the market conditions on a case-by-case basis. In liner shipping, volume and/or capacity data have been identified as the basis for calculating market shares in several Commission decisions and Court judgments (32).

34.

In tramp shipping markets, service providers compete for the award of transport contracts, that is to say, they sell voyages or transport capacity. Depending on the specific services in question, various data may allow operators to calculate their annual market shares (33), for instance:

(a)

the number of voyages;

(b)

the parties' volume or value share in the overall transport of a specific cargo (between port pairs or port ranges);

(c)

the parties' share in the market for time charter contracts;

(d)

the parties' capacity shares in the relevant fleet (by vessel type and size).

3.   HORIZONTAL AGREEMENTS IN THE MARITIME TRANSPORT SECTOR

35.

Cooperation agreements are a common feature of maritime transport markets. Considering that these agreements may be entered into by actual or potential competitors and may adversely affect the parameters of competition, undertakings must take special care to ensure that they comply with the competition rules. In service markets, such as maritime transport, the following elements are particularly relevant for the assessment of the effect an agreement may have in the relevant market: prices, costs, quality, frequency and differentiation of the service provided, innovation, marketing and commercialisation of the service.

36.

Three issues are of particular relevance to the services covered by these guidelines: technical agreements, exchanges of information and pools.

3.1.   Technical agreements

37.

Certain types of technical agreements may not fall under the prohibition set out in Article 81 of the Treaty on the ground that they do not restrict competition. This is the case, for instance, of horizontal agreements the sole object and effect of which is to implement technical improvements or to achieve technical cooperation. Agreements relating to the implementation of environmental standards can also be considered to fall into this category. Agreements between competitors relating to price, capacity, or other parameters of competition will, in principle, not fall into this category (34).

3.2.   Information exchanges between competitors in liner shipping

38.

An information exchange system entails an arrangement on the basis of which undertakings exchange information amongst themselves or supply it to a common agency responsible for centralizing, compiling and processing it before returning it to the participants in the form and at the frequency agreed.

39.

It is common practice in many industries for aggregate statistics and general market information to be gathered, exchanged and published. This published market information is a good means to increase market transparency and customer knowledge, and thus may produce efficiencies. However, the exchange of commercially sensitive and individualised market data can, under certain circumstances, breach Article 81 of the Treaty. These guidelines are intended to assist providers of liner shipping services in assessing when such exchanges breach the competition rules.

40.

In the liner shipping sector, exchanges of information between shipping lines taking part in liner consortia which otherwise would fall under Article 81(1) of the Treaty are permitted to the extent that they are ancillary to the joint operation of liner transport services and the other forms of co-operation covered by the block exemption in Regulation (EC) No 823/2000 (35). The present Guidelines do not deal with these information exchanges.

3.2.1.   In general

41.

In assessing information exchange systems under Community competition law, the following distinctions must be made.

42.

The exchange of information may be a facilitating mechanism for the implementation of an anti-competitive practice, such as monitoring compliance with a cartel; where an exchange of information is ancillary to such an anti-competitive practice its assessment must be carried out in combination with an assessment of that practice. An exchange of information may even have in itself the object of restricting competition (36). These Guidelines do not address such exchanges of information.

43.

However, an exchange of information, in its own right, might constitute an infringement of Article 81 of the Treaty by reason of its effect. This situation arises when the information exchange reduces or removes the degree of uncertainty as to the operation of the market in question with the result that competition between undertakings is restricted (37). Every economic operator must determine autonomously the policy which it intends to pursue on the market. The Court further considered that undertakings are, therefore, precluded from direct or indirect contacts with other operators which influence the conduct of a competitor or reveal their own (intended) conduct if the object or effect of those contacts is to restrict competition, i.e. to give rise to conditions of competition which do not correspond to the normal conditions of the market in question, taking into account the nature of the products or the services provided, the size and number of the undertakings and the volume of the market (38). By contrast, in the wood pulp market, the Court has found that unilateral quarterly price announcements made independently by producers to users constitute in themselves market behaviour which does not lessen each undertaking's uncertainty as to the future attitude of its competitors and hence, in the absence of any preliminary concerted practice between producers, do not constitute in themselves an infringement of Article 81(1) of the Treaty (39).

44.

The case law of the Community Courts provides some general guidance in examining the likely effects of an information exchange. The Court has found that where there is a truly competitive market, transparency is likely to lead to intensification of competition between suppliers (40). However, on a highly concentrated oligopolistic market, on which competition is already greatly reduced, exchanges of precise information on individual sales at short intervals between the main competitors, to the exclusion of other suppliers and of consumers, are likely to impair substantially the competition that exists between suppliers. In such circumstances, the sharing, on a regular and frequent basis, of information concerning the operation of the market has the effect of periodically revealing to all competitors the market positions and strategies of the various individual competitors (41). The Court has also found that an information exchange system may constitute a breach of the competition rules even when the market is not highly concentrated but there is a reduction of the undertakings' decision-making autonomy resulting from pressure during subsequent discussions with competitors (42).

45.

It follows that the actual or potential effects of an information exchange must be considered on a case-by-case basis as the results of the assessment depend on a combination of factors, each specific to an individual case. The structure of the market where the exchange takes place and the characteristics of the information exchange, are two key elements that the Commission examines when assessing an information exchange. The assessment must consider the actual or potential effects of the information exchange compared to the competitive situation that would result in the absence of the information exchange agreement (43). To be caught by Article 81(1) of the Treaty, the exchange must have an appreciable adverse impact on the parameters of competition (44).

46.

The guidance below mainly relates to the analysis of a restriction of competition under Article 81(1) of the Treaty. Guidance on the application of Article 81(3) of the Treaty is to be found in paragraph 58 below and in the general notice on the subject (45).

3.2.2.   Market structure

47.

The level of concentration and the structure of supply and demand on a given market are key issues in considering whether an exchange falls within the scope of Article 81(1) of the Treaty (46).

48.

The level of concentration is particularly relevant since, on highly concentrated oligopolistic markets, restrictive effects are more likely to occur and are more likely to be sustainable than in less concentrated markets. Greater transparency in a concentrated market may strengthen the interdependence of firms and reduce the intensity of competition.

49.

The structure of supply and demand is also important, notably the number of competing operators and the symmetry and stability of their market shares and the existence of any structural links between competitors (47).The Commission may also analyse other factors such as the homogeneity of services and the overall transparency in the market.

3.2.3.   Characteristics of the information exchanged

50.

The exchange of commercially sensitive data relating to the parameters of competition, such as price, capacity or costs, between competitors, is more likely to be caught by Article 81(1) of the Treaty than other exchanges of information. The commercial sensitivity of information should be assessed taking into account the criteria set out below.

51.

The exchange of information already in the public domain does not in principle constitute an infringement of Article 81(1) of the Treaty (48). However, it is important to establish the level of transparency of the market and whether the exchange enhances information by making it more accessible and/or combines publicly available information with other information. The resulting information may become commercially sensitive and its exchange potentially restrictive of competition.

52.

Information may be individual or aggregated. Individual data relates to a designated or identifiable undertaking. Aggregate data combines the data from a sufficient number of independent undertakings so that the recognition of individual data is impossible. The exchange of individual information between competitors is more likely to be caught by Article 81(1) of the Treaty (49) than the exchange of aggregated information which, in principle, does not fall within Article 81(1) of the Treaty. The Commission will pay particular attention to the level of aggregation. It should be such that the information cannot be disaggregated so as to allow undertakings directly or indirectly to identify the competitive strategies of their competitors.

53.

However, in liner shipping caution should be used when assessing exchanges of capacity forecasts even in aggregate form, especially when they take place in concentrated markets. In liner markets, capacity data is the key parameter to coordinate competitive conduct and it has a direct effect on prices. Exchanges of aggregated capacity forecasts indicating in which trades capacity will be deployed may be anticompetitive to the extent that they may lead to the adoption of a common policy by several or all carriers and result in the provision of services at above competitive prices. Additionally, there is a risk of disaggregation of the data as it can be combined with individual announcements by liner carriers. This would enable undertakings to identify the market positions and strategies of competitors.

54.

The age of the data and the period to which it relates are also important factors. Data can be historic, recent or future. Exchange of historic information is generally not regarded as falling within Article 81(1) of the Treaty because it cannot have any real impact on the undertakings' future behaviour. In past cases, the Commission has considered information which was more than one year old as historic (50) whereas information less than one year old has been viewed as recent (51). The historic or recent nature of the information should be assessed with some flexibility taking into account the extent to which data becomes obsolete in the relevant market. The time when the data becomes historic is likely to be shorter if the data is aggregated rather than individual. Exchanges of recent data on volume and capacity are similarly unlikely to be restrictive of competition if the data is aggregated to an appropriate level such that individual shippers' or carriers' transactions cannot be identified either directly or indirectly. Future data relates to an undertaking's view of how the market will develop or to the strategy it intends to follow in that market. The exchange of future data is particularly likely to be problematic, especially when it relates to prices or output. It may reveal the commercial strategy an undertaking intends to adopt in the market. In so doing, it may appreciably reduce rivalry between the parties to the exchange and is thus potentially restrictive of competition.

55.

The frequency of the exchange should also be considered. The more frequently the data is exchanged, the more swiftly competitors can react. This facilitates retaliation and ultimately lowers the incentives to initiate competitive actions on the market. So-called hidden competition could be restricted.

56.

How data is released should also be looked into to assess the effect(s) it may have on the market(s). The more the information is shared with customers, the less likely it is to be problematic. Conversely, if market transparency is improved for the benefit of suppliers only, it may deprive customers of the possibility of getting the advantage of increased ‘hidden competition’.

57.

In liner shipping, price indexes are used to show average price movements for the transport of a sea container. A price index based on appropriately aggregated price data is unlikely to infringe Article 81(1) of the Treaty, provided that the level of aggregation is such that the information cannot be disaggregated so as to allow undertakings directly or indirectly to identify the competitive strategies of their competitors. If a price index reduces or removes the degree of uncertainty as to the operation of the market with the result that competition between undertakings is restricted, it would violate Article 81(1) of the Treaty. In assessing the likely effect of such a price index on a given relevant market, account should be given to the level of aggregation of the data and its historical or recent nature and the frequency at which the index is published. In general it is important to assess all individual elements of any information exchange scheme together, in order to take account of potential interactions, for example between exchange of capacity and volume data on the one hand and of a price index on the other.

58.

An exchange of information between carriers that restricts competition may nonetheless create efficiencies, such as better planning of investments and more efficient use of capacity. Such efficiencies will have to be substantiated and passed on to customers and weighed against the anti-competitive effects of the information exchange in the framework of Article 81(3) of the Treaty. In this context, it is important to note that one of the conditions of Article 81(3) is that consumers should receive a fair share of the benefits generated by the restrictive agreement. If all four cumulative conditions set out in Article 81(3) are fulfilled, the prohibition of Article 81(1) does not apply (52).

3.2.4.   Trade associations

59.

In liner shipping, as in any other sector, discussions and exchanges of information can take place in a trade association provided the association is not used as (a) a forum for cartel meetings (53); (b) a structure that issues anti-competitive decisions or recommendations to its members (54); or (c) a means of exchanging information that reduces or removes the degree of uncertainty as to the operation of the market with the result that competition between undertakings is restricted while not fulfilling the Article 81(3) conditions (55). This should be distinguished from the discussions that are legitimately conducted within trade associations, for example on technical and environmental standards.

3.3.   Pool agreements in tramp shipping

60.

The most recurrent form of horizontal cooperation in the tramp shipping sector is the shipping pool. There is no universal model for a pool. Some features do, however, appear to be common to most pools in the different market segments as set out below.

61.

A standard shipping pool brings together a number of similar vessels (56) under different ownership and operated under a single administration. A pool manager is normally responsible for the commercial management (for example, joint marketing (57), negotiation of freight rates and centralization of incomes and voyage costs (58)) and the commercial operation (planning vessel movements and instructing vessels, nominating agents in ports, keeping customers updated, issuing freight invoices, ordering bunkers, collecting the vessels' earnings and distributing them under a pre-arranged weighting system etc.). The pool manager often acts under the supervision of a general executive committee representing the vessel owners. The technical operation of vessels is usually the responsibility of each owner (safety, crew, repairs, maintenance etc.). Although they market their services jointly, the pool members often perform the services individually.

62.

It follows from this description that the key feature of standard shipping pools is joint selling, coupled with features of joint production. The guidance on both joint selling, as a variant of a joint commercialisation agreement, and joint production in the Commission Guidelines on the applicability of Article 81 of the Treaty to horizontal cooperation agreements (59) is therefore relevant. Given the variation in pools' characteristics, each pool must be analysed on a case-by-case basis to determine, by reference to its centre of gravity (60), whether it is caught by Article 81(1) and, in the affirmative, if it fulfils the four cumulative conditions of Article 81(3).

63.

Pools that fall within the scope of Council Regulation (EC) No 139/2004 (61) because they are created as a joint venture performing on a lasting basis all the functions of an autonomous economic entity (so called full-function joint ventures, see Article 3(4) of Regulation (EC) No 139/2004) are not directly affected by the changes brought about by Regulation (EC) No 1419/2006 and are not dealt with in these Guidelines. Guidance on full-functionality can be found, inter alia, in the Commission Consolidated Jurisdictional Notice under Regulation (EC) No 139/2004 on the control of concentrations between undertakings (62). Insofar as such pools have as their object or effect the coordination of the competitive behaviour of their parents, the coordination shall be appraised in accordance with the criteria of Article 81(1) and (3) of the EC Treaty with a view to establishing whether or not the operation is compatible with the common market (63).

3.3.1.   Pools that do not fall under Article 81(1) of the Treaty

64.

Pool agreements do not fall under the prohibition of Article 81(1) of the Treaty if the participants to the pool are not actual or potential competitors. This would be the case, for instance, when two or more ship-owners set up a shipping pool for the purpose of tendering for and performing contracts of affreightment for which as individual operators they could not bid successfully or which they could not carry out on their own. This conclusion is not invalidated in cases where such pools occasionally carry other cargo representing a small part of the overall volume.

65.

Pools whose activity does not influence the relevant parameters of competition because they are of minor importance and/or do not appreciably affect trade between Member States (64), are not caught by Article 81(1) of the Treaty.

3.3.2.   Pools that generally fall under Article 81(1) of the Treaty

66.

Pool agreements between competitors limited to joint selling have as a rule the object and effect of coordinating the pricing policy of these competitors (65).

3.3.3.   Pools that may fall under Article 81(1) of the Treaty

67.

If the pool does not have as its object a restriction of competition, an analysis of its effects in the market concerned is necessary. An agreement is caught by Article 81(1) of the Treaty when it is likely to have an appreciable adverse impact on the parameters of competition on the market such as prices, costs, service differentiation, service quality, and innovation. Agreements can have this effect by appreciably reducing rivalry between the parties to the agreement or between them and third parties (66).

68.

Some tramp shipping pools do not involve joint selling but nevertheless entail some degree of coordination on the parameters of competition (e.g. joint scheduling or joint purchasing). Such cases are only subject to Article 81(1) of the Treaty if the parties to the agreement have some degree of market power (67).

69.

The pool's ability to cause appreciable negative market effects depends on the economic context, taking into account the parties' combined market power and the nature of the agreement together with other structural factors in the relevant market. It must also be considered whether the pool agreement affects the behaviour of the parties in neighbouring markets closely related to the market directly affected by the cooperation (68). This may be the case for example where the pool's market is that for the transport of forest products in specialised box shaped vessels (market A) and the pool's members also operate ships in the dry bulk market (market B).

70.

Concerning the structural factors in the relevant market, if the pool has a low market share, it is unlikely to produce restrictive effects. Market concentration, the position and number of competitors, the stability of market shares over time, multi-membership in pools, market entry barriers and the likelihood of entry, market transparency, countervailing buying power of transport users and the nature of the services (for example, homogenous versus differentiated services) should be taken into account as additional factors in assessing the impact of a given pool on the relevant market.

71.

With regard to the nature of the agreement, consideration should be given to clauses affecting the pool or its members' competitive behaviour in the market such as clauses prohibiting members from being active in the same market outside the pool (non-compete clauses), lock-in periods and notice periods (exit clauses) and exchanges of commercially sensitive information. Any links between pools, whether in terms of management or members as well as cost and revenue sharing should also be considered.

3.3.4.   Applicability of Article 81(3) of the Treaty

72.

Where pools are caught by Article 81(1) of the Treaty, the undertakings involved need to ensure that they fulfil the four cumulative conditions of Article 81(3) (69). Article 81(3) does not exclude a priori certain types of agreements from its scope. As a matter of principle all restrictive agreements that fulfil the four conditions of Article 81(3) are covered by the exception rule. This analysis incorporates a sliding scale. The greater the restriction of competition found under Article 81(1), the greater the efficiencies and the pass-on to consumers must be.

73.

It is up to the undertakings involved to demonstrate that the pool improves the transport services or promotes technical or economic progress in the form of efficiency gains. The efficiencies generated cannot be cost savings that are an inherent part of the reduction of competition but must result from the integration of economic activities.

74.

Efficiency gains of pools may for instance result from obtaining better utilisation rates and economies of scale. Tramp shipping pools typically jointly plan vessel movements in order to spread their fleets geographically. Spreading vessels may reduce the number of ballast voyages which may increase the overall capacity utilisation of the pool and eventually lead to economies of scale.

75.

Consumers must receive a fair share of the efficiencies generated. Under Article 81(3) of the Treaty, it is the beneficial effects on all consumers in the relevant market that must be taken into consideration, not the effect on each individual consumer (70). The pass-on of benefits must at least compensate consumers for any actual or potential negative impact caused to them by the restriction of competition under Article 81(1) (71). To assess the likelihood of a pass-on the structure of tramp shipping markets and the elasticity of demand should also be considered in this context.

76.

A pool must not impose restrictions that are not indispensable to the attainment of the efficiencies. In this respect it is necessary to examine whether the parties could have achieved the efficiencies on their own. In making this assessment it is relevant to consider, inter alia, what is the minimum efficient scale to provide various types of services in tramp shipping. In addition, each restrictive clause contained in a pool agreement must be reasonably necessary to attain the claimed efficiencies. Restrictive clauses may be justified for a longer period or the whole life of the pool or for a transitional period only.

77.

Lastly, the pool must not afford the parties the possibility of eliminating competition in respect of a substantial part of the services in question.


(1)  Council Regulation (EC) No 1419/2006 of 25 September 2006 repealing Regulation (EEC) No 4056/86 laying down detailed rules for the application of Articles 85 and 86 (now 81 and 82) of the Treaty to maritime transport, and amending Regulation (EC) No 1/2003 as regards the extension of its scope to include cabotage and international tramp services (OJ L 269, 28.9.2006, p. 1).

(2)  The term ‘agreement’ is used for agreements, decisions by associations of undertakings and concerted practices.

(3)  OJ L 1, 4.1.2003, p. 1.

(4)  OJ L 123, 27.4.2004, p. 18.

(5)  OJ L 378, 31.12.1986, p. 4.

(6)  OJ C 3, 6.1.2001, p. 2.

(7)  OJ C 101, 27.4.2004, p. 97.

(8)  OJ L 100, 20.4.2000, p. 24.

(9)  Recital 3 of Regulation (EC) 611/2005, cited above in footnote 8.

(10)  The Commission has identified a series of characteristics specific to specialised transport which render it distinct from liner services and tramp vessel services. They involve the provision of regular services for a particular cargo type. The service is usually provided on the basis of contracts of affreightment using specialised vessels technically adapted and/or built to transport specific cargo. Commission Decision 94/980/EC of 19 October 1994 in Case IV/34.446 — Trans-Atlantic Agreement (OJ L 376, 31.12.1994, p. 1) (hereinafter the TAA decision), paragraphs 47-49.

(11)  Article 1 of Council Regulation (EEC) No 3577/92 of 7 December 1992 applying the principle of freedom to provide services to maritime transport within Member States (maritime cabotage) (OJ L 364, 12.12.1992, p. 7).

(12)  Case 42/84, Remia BV and Others v Commission [1985] ECR 2545, paragraph 22. Case 319/82, Ciments et Bétons de l'Est v Kerpen & Kerpen [1983] ECR 4173, paragraph 9.

(13)  OJ C 101, 27.4.2004, p. 81.

(14)  The fact that the service is to/from a non-EU port does not in itself preclude that trade between Member States is affected. A careful analysis of the effects on customers and other operators within the Community that rely on the services needs to be carried out to determine whether they fall under Community jurisdiction. See Guidelines on the effect on trade concept contained in Articles 81 and 82 of the Treaty, cited above in footnote 13.

(15)  Commission Decision 93/82/EEC of 23 December 1992 (Cases IV/32.448 and IV/32.450, CEWAL) (OJ L 34, 10.2.1993, p. 1), paragraph 90, confirmed by the Court of First Instance in Joined Cases T-24/93 to T-26/93 and T-28/93, Compagnie Maritime Belge and Others v Commission [1996] ECR II-1201, paragraph 205. TAA decision, cited above in footnote 10, paragraphs 288-296, confirmed by the Judgment of the Court of First Instance of 28 February 2002, in Case T-395/94, Atlantic Container Line and Others v Commission (hereinafter the TAA judgment), paragraphs 72-74; Commission Decision 1999/243/EC of 16 September 1998 (Case IV/35.134 — Trans-Atlantic Conference Agreement) (hereinafter the TACA decision) (OJ L 95, 9.4.1999, p. 1), paragraphs 386-396; Commission Decision 2003/68/EC of 14 November 2002 (Case COMP/37.396 — Revised TACA) (hereinafter the Revised TACA decision) (OJ L 26, 31.1.2003, p. 53), paragraph 73.

(16)  For guidance on the application of the effect on trade, see the Commission Guidelines cited above in footnote 13.

(17)  OJ C 372, 9.12.1997, p. 5.

(18)  Notice on market definition, cited above in footnote 17, paragraph 8.

(19)  Notice on market definition, cited above in footnote 17, paragraph 13.

(20)  Commission Decision 1999/485/EC of 30 April 1999 (Case IV/34.250 — Europe Asia Trades Agreement) (OJ L 193, 26.7.1999, p. 23); TAA decision, cited above in footnote 10, and the TACA decision, cited above in footnote 15, paragraphs 60-84. The market definition in the TACA decision was confirmed by the Court of First Instance in its Judgment in Joined Cases T-191/98, T-212/98 to T-214/98, Atlantic Container Line AB and Others v Commission [2003] ECR II-3275 (hereinafter the TACA judgment), paragraphs 781-883.

(21)  Paragraph 62 of the TACA decision, cited above in footnote 15 and paragraphs 783-789 of the TACA judgment, cited above in footnote 20.

(22)  TACA decision, cited above in footnote 15, paragraph 71.

(23)  TAA judgement, cited above in footnote 15, paragraph 273 and TACA judgment, cited above in footnote 20, paragraph 809.

(24)  TAA judgment, cited above in footnote 15, paragraph 281. Commission Decision of 29 July 2005 in Case COMP/M.3829 — MAERSK/PONL, paragraph 13.

(25)  TACA decision, cited above in footnote 15, paragraphs 62-75; TACA judgment, cited above in footnote 21, paragraph 795 and Commission Decision in MAERSK/PONL, cited above in footnote 23, paragraphs 13 and 112-117.

(26)  TACA decision, cited above in footnote 15, paragraphs 76-83 and Revised TACA decision, cited above in footnote 15, paragraph 39.

(27)  For voyage charter for instance the essential elements of a transport requirement are the cargo to be carried, the cargo volume, the loading and discharging ports, the laydays or the ultimate date by which the cargo has to arrive and technical details regarding the vessel required.

(28)  It appears to be the industry's perception that vessel sizes constitute separate markets. The trade press and the Baltic Exchange publish price indexes for each standard vessel size. Consultants' reports divide the market on the basis of vessel sizes.

(29)  For example, liquid bulk cargo cannot be carried on dry bulk vessels or reefer cargo cannot be transported on car carriers. Many oil tankers are able to carry dirty and clean petroleum products. However, a tanker cannot immediately carry clean products after having transported dirty products.

(30)  Switching a dry bulk vessel from the transport of coal to grain might require only a one-day cleaning process that might be done during a ballast voyage. In other tramp shipping markets this cleaning period may be longer.

(31)  Regulation (EC) No 417/2002 of the European Parliament and of the Council of 18 February 2002 on the accelerated phasing-in of double hull or equivalent design requirements for single hull oil tankers and repealing Council Regulation (EC) No 2978/94 (OJ L 64, 7.3.2002).

(32)  TACA decision, cited above in footnote 15, paragraph 85; Revised TACA decision, cited above in footnote 15, paragraphs 85 and 86 and the TACA judgment, cited above in footnote 20, paragraphs 924, 925 and 927.

(33)  Depending on the specificities of the relevant tramp shipping market shorter periods may be envisaged, e.g. in markets where contracts of affreightment are tendered for periods of less than one year.

(34)  Commission Decision 2000/627/EC of 16 May 2000 (Case IV/34.018 — Far East Trade Tariff Charges and Surcharges Agreement (FETTCSA)) (OJ L 268, 20.10.2000, p. 1), paragraph 153. Judgment of the Court of First Instance of 21 October 1997 in Case T-229/94, Deutsche Bahn AG v Commission [1997] ECR II-1689, paragraph 37.

(35)  Regulation (EC) No 823/2000, cited above in footnote 8, applies to international liner transport services from or to one or more Community ports exclusively for the carriage of cargo chiefly by container — see Articles 1, 2 and Article 3(2)(g) thereof.

(36)  Judgment of the Court of Justice in Case C-49/92 P, Commission v Anic Partecipazioni [1999] ECR I-4125, paragraphs 121 to 126.

(37)  Judgment of the Court of Justice in Case C-7/95 P, John Deere v Commission [1998] ECR I-3111, paragraph 90 and Judgment of the Court of Justice in Case C-194/99 P, Thyssen Stahl v Commission [2003] ECR I-10821, paragraph 81.

(38)  Judgment of the Court of Justice of 23 November 2006 in Case C-238/05, Asnef-Equifax v Asociación de Usuarios de Servicios Bancarios (Ausbanc) [2006] ECR I-11125, paragraph 52 and Judgment of the Court of Justice in Case C-49/92 P, Commission v Anic Partecipazioni, [1999] ECR I-4125, cited above in footnote 36, paragraphs 116 and 117.

(39)  Judgment of the Court of Justice in Joined Cases C-89/85, C-104/85, C-114/85, C-116/85, C-117/85 and C-125/85 to C-129/85, A. Ahlström Osakeyhtiö and Others v Commission [1993] ECR I-1307, paragraphs 59 to 65.

(40)  Judgment in John Deere v Commission, Case C-7/95 P, cited above in footnote 37, paragraph 88.

(41)  Judgment of the Court of First Instance in Case T-35/92, John Deere Ltd v Commission [1994] ECR II-957, paragraph 51, upheld on appeal by the Judgment in Case C-7/95 P, John Deere Ltd v Commission, cited above in footnote 37, paragraph 89; and more recently, the Judgment in Asnef-Equifax v Ausbanc, cited above in footnote 38.

(42)  Judgment of the Court of First Instance in Case T-141/94, Thyssen Stahl AG v Commission [1999] ECR II-347, paragraphs 402 and 403.

(43)  Judgment in Case C-7/95 P, John Deere Ltd v Commission, cited above in footnote 37, paragraphs 75-77.

(44)  Guidelines on the application of Article 81(3), cited above in footnote 7, paragraph 16.

(45)  Guidelines on the application of Article 81(3), cited above in footnote 7.

(46)  Guidelines on the application of Article 81(3), cited above in footnote 7, paragraph 25.

(47)  In liner shipping there are operational and/or structural links between competitors, for example membership of consortia agreements that allow shipping lines to share information for the purposes of providing a joint service. The existence of any such link, will have to be taken into account on a case by case basis when assessing the impact an additional exchange of information has in the market in question.

(48)  TACA judgment, cited above in footnote 20, paragraph 1154.

(49)  Commission Decision 78/252/EEC of 23 December 1977 in Case IV/29.176 — Vegetable Parchment (OJ L 70, 13.3.1978, p. 54).

(50)  Commission Decision 92/157/EEC of 17 February 1992 in Case IV/31.370 — UK Agricultural Tractor Registration Exchange (OJ L 68, 13.3.1992, p. 19), paragraph 50.

(51)  Commission Decision 98/4/ECSC of 26 November 1997 in Case IV/36.069 — Wirtschaftsvereinigung Stahl (OJ L 1, 3.1.1998, p. 10), paragraph 17.

(52)  Guidelines on the application of Article 81(3) of the Treaty, cited above in footnote 7.

(53)  Commission Decision 2004/421/EC of 16 December 2003 in Case COMP/38.240 — Industrial tubes (OJ L 125, 28.4.2004, p. 50).

(54)  Commission Decision 82/896/EEC of 15 December 1982 in Case IV/29.883 — AROW/BNIC (OJ L 379, 31.12.1982, p. 1); Commission Decision 96/438/EC of 5 June 1996 in Case IV/34.983 — Fenex (OJ L 181, 20.7.1996, p. 28).

(55)  Decision 92/157/EEC (UK Agricultural Tractor Registration Exchange), cited above in footnote 50.

(56)  This results in the pool being able to attract large contracts of affeightment, combine various contracts of affeightment and reduce the number of ballast legs by careful fleet planning.

(57)  For example, the pool's vessels are marketed as one commercial unit offering transport solutions regardless of which ship performs the actual voyage.

(58)  For example, the pool's income is collected by the central administration and revenue is distributed to the participants based on a complex weighting system.

(59)  Respectively in Section 5 and Section 3 of the Guidelines, cited above in footnote 6.

(60)  Guidelines on Horizontal Cooperation Agreements, cited above in footnote 6, paragraph 12.

(61)  Council Regulation (EC) No 139/2004 on the control of concentrations between undertakings (the EC Merger Regulation) (OJ L 24, 29.1.2004, p. 1).

(62)  OJ C 95, 16.4.2008, p. 1.

(63)  Article 2(4) of Council Regulation (EC) No 139/2004.

(64)  Commission Notice on agreements of minor importance which do not appreciably restrict competition under Article 81(1) of the Treaty (OJ C 368, 22.12.2001, p. 13) and Guidelines on the effect on trade concept, cited above in footnote 13.

(65)  Guidelines on Horizontal Cooperation Agreements, cited above in footnote 6, Section 5. The activities of an independent ship-broker when ‘fixing a vessel’ do not fall under this category.

(66)  Guidelines on the application of Article 81(3), cited above in footnote 7.

(67)  Guidelines on Horizontal Cooperation Agreements, cited above in footnote 6, paragraph 149.

(68)  Guidelines on Horizontal Cooperation Agreements, cited above in footnote 6, paragraph 142.

(69)  Guidelines on the application of Article 81(3), cited above in footnote 7.

(70)  Judgment in Case C-238/05, Asnef-Equifax v Ausbanc, cited above in footnote 38, paragraph 70.

(71)  Guidelines on the application of Article 81(3), cited above in footnote 7, paragraph 24.


26.9.2008   

EN

Official Journal of the European Union

C 245/15


Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council  (1) )

(2008/C 245/03)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

28.8.2008

INTELENCE

Etravirine

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/08/468/001

Tablet

(Non applicable)

1.9.2008

29.8.2008

Vimpat

Lacosamide

UCB S.A.

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/B-1070 Brussel

EU/1/08/470/001-013

Film-coated tablet

N03AX18

2.9.2008

EU/1/08/470/014-015

Syrup

EU/1/08/470/016

Solution for infusion

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.8.2008

Neupro

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-037

6.8.2008

8.8.2008

Champix

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-012

12.8.2008

8.8.2008

Vectibix

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/07/423/001-003

12.8.2008

8.8.2008

Infanrix hexa

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/152/001-018

12.8.2008

8.8.2008

Evista

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

12.8.2008

8.8.2008

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

12.8.2008

11.8.2008

Optruma

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

13.8.2008

13.8.2008

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

EU/1/07/432/001-022

15.8.2008

13.8.2008

Retacrit

HOSPIRA Enterprises B.V.

Taurusavenue 19-21b

2132 LS Hoofddorp

Nederland

EU/1/07/431/001-019

15.8.2008

13.8.2008

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

15.8.2008

13.8.2008

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/251/001-002

15.8.2008

13.8.2008

Infanrix penta

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/153/001-010

18.8.2008

13.8.2008

Cervarix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/07/419/001-009

18.8.2008

22.8.2008

Evista

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48

D-81379 München

EU/1/98/073/001-004

26.8.2008

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

22.8.2008

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-006

26.8.2008

22.8.2008

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/343/001-007

26.8.2008

22.8.2008

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-006

26.8.2008

22.8.2008

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/05/310/001-009

26.8.2008

22.8.2008

Zalasta

KRKA d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

EU/1/07/415/001-056

26.8.2008

22.8.2008

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-035

26.8.2008

22.8.2008

Revlimid

Celgene Europe Limited

Morgan House

Madeira Walk

Windsor

Berkshire SL4 1EP

United Kingdom

EU/1/07/391/001-004

26.8.2008

25.8.2008

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

27.8.2008

25.8.2008

TARGRETIN

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/01/178/001

27.8.2008

25.8.2008

Emselex

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/04/294/001-028

27.8.2008

25.8.2008

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/050/001-006

EU/1/97/050/009-012

27.8.2008

25.8.2008

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

27.8.2008

25.8.2008

Revatio

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/05/318/001

27.8.2008

25.8.2008

Prialt

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/04/302/001-004

27.8.2008

25.8.2008

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-006

27.8.2008

26.8.2008

Viagra

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/98/077/002-004

EU/1/98/077/006-008

EU/1/98/077/010-019

28.8.2008

28.8.2008

Rasilez

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/405/001-020

1.9.2008

28.8.2008

Tekturna

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/408/001-020

1.9.2008

28.8.2008

Raptiva

Serono Europe Limited

56 Marsh Wall

London E14 9TP

United Kingdom

EU/1/04/291/001-003

1.9.2008

28.8.2008

ISENTRESS

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/436/001-002

1.9.2008

28.8.2008

Enviage

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/406/001-020

1.9.2008

28.8.2008

Sprimeo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/407/001-020

1.9.2008

28.8.2008

Riprazo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/409/001-020

1.9.2008

29.8.2008

Avastin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/04/300/001-002

2.9.2008

29.8.2008

Nespo

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

2.9.2008

29.8.2008

Enbrel

Wyeth Europa Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

1.9.2008

29.8.2008

Velcade

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/04/274/001-002

2.9.2009

29.8.2008

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2.9.2009

29.8.2008

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/001

2.9.2009

29.8.2008

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/04/305/001-002

2.9.2009

29.8.2008

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/038-055

2.9.2009

29.8.2008

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-055

2.9.2009

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

22.8.2008

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

26.8.2008

28.8.2008

Quintanrix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/04/301/001-005

1.9.2008

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

13.8.2008

Dexdomitor

Orion Corporation

Orionintie 1

FI-02200 Espoo

EU/2/02/033/001-002

15.8.2008

22.8.2008

Suvaxyn Aujeszky

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

Nederland

EU/2/98/009/001-006

26.8.2008

25.8.2008

Zubrin

Schering-Plough Limited

Schering-Plough House

Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/2/00/028/002-008

27.8.2008

25.8.2008

Circovac

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/07/075/001-004

27.8.2008

25.8.2008

Profender

Bayer HealthCare AG

D-51368 Leverkusen

EU/2/05/054/018-031

27.8.2008

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom


(1)  OJ L 136, 30.4.2004, p. 1.


26.9.2008   

EN

Official Journal of the European Union

C 245/21


Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council  (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council  (2) )

(2008/C 245/04)

—   Suspension of a national marketing authorization

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.8.2008

Coxtral gel

See Annex I

See Annex I

18.9.2008


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Content

(Concentration)

Czech Republic

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

 

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Estonia

 

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneus use

30 mg/g

Hungary

 

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cuteaneus use

30 mg/g

Lithuania

 

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Latvia

 

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Poland

 

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Slovakia

 

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g


V Announcements

ADMINISTRATIVE PROCEDURES

Commission

26.9.2008   

EN

Official Journal of the European Union

C 245/23


Call for expressions of interest in membership in the scientific risk assessment Advisory Structure of Scientific Committees and database of experts

(2008/C 245/05)

This call is addressed to scientists who wish to be considered for membership in the Advisory Structure of the European Commission in the fields of consumer safety, public health and the environment. The Advisory Structure of scientific committees and experts is established by Commission Decision 2008/721/EC which is available on the following site:

http://ec.europa.eu/health/ph_risk/committees/call_expression_en.htm

The Advisory Structure on scientific risk assessment in the areas of consumer safety, public health and the environment includes the following:

(a)

the Scientific Committee on Consumer Safety (hereinafter ‘SCCS’);

(b)

the Scientific Committee on Health and Environmental Risks (hereinafter ‘SCHER’);

(c)

the Scientific Committee on Emerging and Newly Identified Health Risks (hereinafter ‘SCENIHR’);

(d)

a Pool of Scientific Advisors on Risk Assessment (hereinafter ‘the Pool’), which will support the activities of the Scientific Committees.

The role of the Scientific Committees and the Pool is to give the Commission high quality and independent scientific advice, when requested, on non-food matters related to consumer safety or risks to public health or to the environment. The Committees also draw the Commission's attention to specific or emerging problems falling within their remit. The work of the Advisory Structure is based on the principles of excellence, independence and transparency.

In parallel, the Commission intends to establish a database of experts in order to facilitate access to a very broad range of expertise to support the work of the Advisory Structure.

Composition and remit of the Advisory Structure

The SCCS, the SCHER and the SCENIHR will each consist of a maximum of 17 members and may associate, at their own initiative, up to 5 scientific advisors from the Pool to contribute to a committee's work on specific issues. These associated members participate in the activities and deliberations concerning the subject considered with the same functions, responsibilities and rights as the members of the Committee. Members of the Pool may also be called upon by the Commission to replace on a permanent basis members of the Scientific Committees who resign or whose membership is terminated. Members of the Pool may be included in the activities of different working groups, in the provision of rapid advice requested by the Commission, or in thematic workshops/scientific meetings. The number of scientific advisors in the Pool at any time is decided by the Commission based on its needs for scientific advice.

Members of the Advisory Structure are appointed by the Commission on the basis of their expertise in one or more of the fields of competence and collectively cover the widest possible range of disciplines. The fields of competence are set out in Annex I of Decision 2008/721/EC.

Members are appointed to the Scientific Committees for a term of three years and may not serve more than three consecutive terms. They remain in office until they are replaced or their appointments are renewed. Scientific advisors are appointed to the Pool for a period of five years and their appointment may be renewed.

Candidates may wish to apply for inclusion in the database of external experts on health, safety and environmental risk assessment. The database option is indicated on the application form. Database-only applicants will be accepted on a continuous basis. These external experts may be invited to participate in the work of the Scientific Committees on an ad hoc basis, on specific issues, as members of working groups or on the occasion of hearings and workshops. The 10 years experience mentioned below for members of the Scientific Committees and the Pool is not required in this case.

Overall, interested scientists may apply for membership in: (i) the Scientific Committees; and/or (ii) the Pool; and/or (iii) the Database of external experts.

Eligibility

Applicants must have:

a university degree in a relevant scientific area, preferably at postgraduate level,

at least 10 years' professional experience (not required for database-only applicants),

good knowledge of the English language.

This call for expressions of interest is open to scientists from Europe and elsewhere.

Selection criteria

Preference will be given to candidates who possess:

professional experience of relevance for application to the fields of competence of the committees listed in Annex I of Decision 2008/721/EC,

experience in carrying out risk assessment and/or providing scientific advice, especially in fields related to consumer safety, public health and the environment,

analytical skills: analysing complex information and dossiers and peer reviewing scientific work and publications,

proven scientific excellence in one, or preferably several fields linked to the area covered by the scientific committee(s) of interest to the applicant,

professional experience in a multi-disciplinary and international environment,

managerial/organisational skills, in particular in chairing and organising working groups.

Selection procedure

The selection procedure will consist of three stages:

(i)

verification of the admissibility of the applications;

(ii)

comparative evaluation and establishment of a list of most suitable applicants; and

(iii)

appointment of members of the Scientific Committees and of the Pool from this list.

The selection board/s will be composed of representatives of the Commission services responsible for policy and legislation in the areas of consumer and product safety, public health, the environment and scientific research. The board/s will be chaired by an independent externally-appointed senior scientist/s. Each expression of interest will be assessed individually against the selection criteria by at least two members of the selection board. In its selection process, the Commission will consider the following: experience and scientific background; independence (potential conflicts of interest); representation from different geographic regions and gender balance.

Appointment of members

The Commission will appoint the members of the Scientific Committees and the Pool from the list of candidates established by the selection boards. No member may be appointed to more than one committee. The Commission may appoint a candidate to a committee other than the one for which he or she applied if this committee needs the candidate's expertise, and provided the candidate agrees. Scientists not appointed to one of the Scientific Committees nor to the Pool of Advisors shall be included in the database of external experts.

The names of the appointed members of the Advisory Structure shall be published in the Official Journal of the European Union and on the European Commission's website.

Independence

The members of the Advisory Structure are appointed on a personal basis. Applicants are required to include a declaration of commitment to act independently of any external influence and a declaration of any interests which might be considered prejudicial to their independence. They will be asked to confirm that, if appointed, they will agree to make annual declarations of interest knowing that these will be made public.

Workload and indemnities

Applicants should be prepared to attend meetings on a regular basis, to actively contribute to scientific discussions, to examine documents and to make comments during meetings of Committees and their working groups, to attend workshops and hearings on invitation and act as ‘chairs’ and/or ‘rapporteurs’ of working groups, on an ad hoc basis. Most of the working documents are in English and the meetings are also conducted in English. Applicants should take into account that meetings in general involve preparatory work. It is estimated that each scientific committee will meet in plenary sessions between five and ten times per year. Members involved in working groups will need to attend more meetings. Candidates should be willing to work with electronic methods for the management and exchange of documents.

Members of the Advisory Structure and the external experts will be entitled to an indemnity related to their participation in the meetings of the committees and for serving as a rapporteur on a specific question. The indemnities are provided for in Annex III of Decision 2008/721/EC. Members will also be entitled to travel and subsistence allowances, in accordance with the rules laid down by the Commission.

Application procedure

Starting on the 20 September 2008, or soon thereafter, interested scientists are invited to fill out and submit the online application form which includes a curriculum vitae and a list of publications as attachments. The application form requires Adobe Acrobat Reader 9.0 which may be downloaded from:

http://www.adobe.com/products/acrobat/readstep2.html

The announcement for the application procedure and the application form are available at the internet site below.

http://ec.europa.eu/health/ph_risk/committees/call_expression_en.htm

The closing date for submitting applications for membership in the Advisory Structure is 31 October 2008. Only online applications submitted via the Internet above will be considered.

Please note that registration in the Database of experts will remain permanently open (no deadline set). Applicants registered in the database will be expected to update the information requested every two years.

An application will be deemed admissible only if it includes:

a completed obligatory application form,

a curriculum vitae, preferably not exceeding three pages (attached to the application form),

a list of the applicant's scientific publications (attached to the application form),

a declaration of interests completed in a true manner (included in the application form).

Supporting documents may be requested at a later stage. All expressions of interest will be treated confidentially. The Commission will inform the candidates of the result of the selection procedures as soon as possible.


PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

26.9.2008   

EN

Official Journal of the European Union

C 245/26


Prior notification of a concentration

(Case COMP/M.5251 — System Capital Management-Energies/Metinvest)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 245/06)

1.

On 17 September 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertakings System Capital Management Limited (‘SCM’, Cyprus) and Energees Investments Limited (‘Energees’, Cyprus) belonging to the SMART Group acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertakings Metinvest BV (‘MIBV’, The Netherlands) and its subsidiaries Makeeva Metallurgical Plant (‘MMZ’, Ukraine) and Promet Steel JSC (‘Promet’, Bulgaria) by way of purchase of shares.

2.

The business activities of the undertakings concerned are:

for SCM: production of metals and coal,

for Energees: production of steel,

for MIBV: iron ore and coal mining, semi-finished and finished steel production,

for MMZ: production and sale of raw steel materials and manufacturing of downstream products in the steel sector,

for Promet: production of downstream products in the steel sector.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5251 — System Capital Management-Energies/Metinvest, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel


(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.


26.9.2008   

EN

Official Journal of the European Union

C 245/27


Prior notification of a concentration

(Case COMP/M.5178 — OEP/Pfleiderer)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 245/07)

1.

On 17 September 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking OEP Holding Corporation (‘OEP’, USA), an indirect subsidiary of J.P. Morgan Chase & Co. (USA) acquires within the meaning of Article 3(1)(b) of the Council Regulation sole control of the undertaking Pfleiderer AG (‘Pfleiderer’, Germany) by way of purchase of shares.

2.

The business activities of the undertakings concerned are:

for OEP: private equity fund,

for Pfleiderer: manufacturing, distribution and marketing of engineered wood, surface finished products and laminate flooring.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5178 — OEP/Pfleiderer, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussels


(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.


Corrigenda

26.9.2008   

EN

Official Journal of the European Union

C 245/28


Corrigendum to Commission notice pursuant to Article 4(1)(a) of Council Regulation (EEC) No 2408/92 — Modification by Italy of the public service obligation in respect of the scheduled air service between Pantelleria-Trapani

( Official Journal of the European Union C 230 of 9 September 2008 )

(2008/C 245/08)

On page 17, the text of the notice should read as follows:

‘In accordance with Article 4(1)(a) of Council Regulation (EEC) No 2408/92 of 23 July 1992 on access for Community air carriers to intra-Community air routes, the Italian Government has decided to modify the public service obligation in respect of the scheduled air services between Pantelleria and Trapani, published in Official Journal of the European Union C 112 of 12 May 2006 and amended in Official Journal of the European Union C 141 of 26 June 2007 and Official Journal of the European Union C 121 of 17 May 2008.

In accordance with point 2.4(c) of the public service obligation, the fares are revised as follows:

Route

Revised fare

(excluding VAT)

Pantelleria-Trapani or vice versa

EUR 26,53

The other requirements of the public service obligation published in Official Journal of the European Union C 112 of 12 May 2006 remain unchanged.’


26.9.2008   

EN

Official Journal of the European Union

C 245/s3


NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.