do-me/EUR-LEX huggingface dataset:
Summary of Community decisions on marketing authorizations in respect of medicinal products from 10 May 2005 to 15 June 2005(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2005-06-24
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 153/6

EN

Official Journal of the European Union

24.6.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 10 May 2005 to 15 June 2005

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2005/C 153/04)

— Issuing, maintenance or modification 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

10.5.2005

See Annex

Regividon

See Annex

See Annex

24.5.2005

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

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

ANNEX

Member State

Marketing authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Belgium

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

Coated tablets

Oral Use

Coated tablets

Oral Use

Denmark

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

Coated tablets

Oral Use

Germany

Greece

Ireland

Italy

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

Luxembourg

Medimpex France S.A.

Rigevidon

The Netherlands

Medimpex France S.A.

Rigevidon

Norway

Portugal

Spain

Sweden

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

Medimpex France S.A.

Rigevidon

United Kingdom

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

0,03 mg Ethinylestradiol
0,150 mg Levonorgestrel

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

Coated tablets

Oral Use

.

.

2
4
6
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
5
3
/
7
Prior notification of a concentration (Case COMP/M.3822 — Stora Enso/Schneidersöhne Papier) Text with EEA relevance
Date: 2005-06-24
Institutions: European Commission
Subjects: economic concentration, merger control, pulp and paper industry

C 153/2

EN

Official Journal of the European Union

24.6.2005

Prior notification of a concentration

(Case COMP/M.3822 — Stora Enso/Schneidersöhne Papier)

(2005/C 153/02)

(Text with EEA relevance)

1.
On 17 June 2005 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 Stora Enso Oyi (‘Stora
Enso’, Finland) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the
whole of G Schneider & Söhne Gmbh & Co KG (‘Schneider’, Germany) by way of purchase of shares.

2.

The business activities of the undertakings concerned are:

— for Stora Enso: production and sale of forest industry products, in particular paper; board, pulp and

sawn timber. It is also active in paper merchanting;

— for Schneider: paper merchant.

On preliminary examination, the Commission finds that the notified transaction could fall within the

3.
scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

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

4.
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 (No (32-2) 296 43 01 or 296 72 44) or by post,
under reference number COMP/M.3822 — Stora Enso/Schneidersöhne Papier to the following address:

European Commission
Directorate-General for Competition
Merger Registry
J-70
B-1049 Brussels

(1) OJ L 24, 29.1.2004, p. 1.
2005/570/: Council Decision of 24 June 2005 appointing two German members and two German alternate members of the Committee of the Regions
Date: 2005-06-24
Institutions: Council of the European Union
Subjects: European Committee of the Regions, Germany, appointment of staff

23.7.2005

EN

Official Journal of the European Union

L 193/29

II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL DECISION

of 24 June 2005

appointing two German members and two German alternate members of the Committee of the
Regions

THE COUNCIL OF THE EUROPEAN UNION,

(2005/570/EC)

Having regard to the Treaty establishing the European Community, and in particular Article 263 thereof,

Having regard to the proposal from the German Government,

Whereas:

(1)

(2)

On 22 January 2002 the Council adopted Decision 2002/60/EC (1) appointing the members
and alternate members of the Committee of the Regions for the period from 26 January 2002 to
25 January 2006.

Two members’ seats on the Committee of the Regions have become vacant following expiry of the
mandates of Mr Stanislaw TILLICH and Ms Ulrike RODUST and two alternate members’ seats on the
Committee of the Regions have become vacant following expiry of the mandates of Mr Volker
SCHIMPFF and Ms Heide SIMONIS,

HAS DECIDED AS FOLLOWS:

Article 1

The following are hereby appointed to the Committee of the Regions for the remainder of the term of office
still to run, namely until 25 January 2006:

(a) as members:

Mr Uwe DÖRING
Minister für Justiz, Arbeit und Europa des Landes Schleswig-Holstein

to replace Ms Ulrike RODUST;

Mr Hermann WINKLER
Sächsischer Staatsminister und Chef der Staatskanzlei,
Mitglied des Sächsischen Landtages

to replace Mr Stanislaw TILLICH;

(1) OJ L 24, 26.1.2002, p. 38.

L 193/30

EN

Official Journal of the European Union

23.7.2005

(b) as alternate members:

Mr Peter Harry CARSTENSEN
Ministerpräsident des Landes Schleswig-Holstein

to replace Ms Heide SIMONIS;

Mr Georg MILBRADT
Ministerpräsident des Freistaates Sachsen,
Mitglied des Sächsischen Landtages

to replace Mr Volker SCHIMPFF.

This Decision shall be published in the Official Journal of the European Union.

It shall take effect on the day of its adoption.

Article 2

Done at Luxembourg, 24 June 2005.

For the Council
The President

L. LUX
2005/479/EC: Council Decision of 24 June 2005 appointing an alternate member of the Committee of the Regions
Date: 2005-06-24
Institutions: Council of the European Union
Subjects: European Committee of the Regions, appointment of staff

2.7.2005

EN

Official Journal of the European Union

L 171/27

COUNCIL DECISION

of 24 June 2005

appointing an alternate member of the Committee of the Regions

(2005/479/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 263 thereof,

Having regard to the proposal from the United Kingdom Government,

Whereas:

(1)

(2)

On 22 January 2002 the Council adopted Decision 2002/60/EC (1) appointing the members and
alternate members of the Committee of the Regions for the period 26 January 2002 to 25 January
2006.

A seat as an alternate member of the Committee of the Regions has become vacant following the
death of Ms Ruth BAGNALL,

HAS DECIDED AS FOLLOWS:

Ms Sharon TAYLOR
Member of the East of England Regional Assembly
(Stevenage Borough Council)

Article 1

is hereby appointed an alternate member of the Committee of the Regions in place of Ms Ruth BAGNALL for
the remainder of her term of office, which runs until 25 January 2006.

This Decision shall be published in the Official Journal of the European Union.

Article 2

It shall take effect on the date of its adoption.

Done at Luxembourg, 24 June 2005.

For the Council
The President

L. LUX

(1) OJ L 24, 26.1.2002, p. 38.
Commission Regulation (EC) No 976/2005 of 24 June 2005 fixing the maximum export refund on wholly milled and parboiled long grain B rice to certain third countries in connection with the invitation to tender issued in Regulation (EC) No 2032/2004
Date: 2005-06-24
Institutions: European Commission
Subjects: award of contract, export refund, rice, third country

25.6.2005

EN

Official Journal of the European Union

L 165/9

COMMISSION REGULATION (EC) No 976/2005

of 24 June 2005

fixing the maximum export refund on wholly milled and parboiled long grain B rice to certain third
countries in connection with the invitation to tender issued in Regulation (EC) No 2032/2004

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EC) No 1785/2003 of
29 September 2003 on the common organisation of
the
market in rice (1), and in particular Article 14(3) thereof,

(3)

(4)

The application of the abovementioned criteria to the
current market situation for the rice in question results
in the maximum export refund being fixed at the amount
specified in Article 1.

The measures provided for in this Regulation are in
the Management
accordance with the opinion of
Committee for Cereals,

Whereas:

(1)

(2)

An invitation to tender for the export refund on rice
was issued pursuant
to Commission Regulation (EC)
No 2032/2004 (2).

Article 5 of Commission Regulation (EEC) No 584/75 (3)
in accordance with the
allows the Commission to fix,
procedure laid down in Article 26(2) of Regulation
(EC) No 1785/2003 and on the basis of the tenders
submitted, a maximum export refund.
In fixing this
maximum, the criteria provided for in Article 14(4) of
Regulation (EC) No 1785/2003 must be taken into
account. A contract is awarded to any tenderer whose
tender is equal to or less than the maximum export
refund.

HAS ADOPTED THIS REGULATION:

Article 1

The maximum export refund on wholly milled and parboiled
long grain B rice to be exported to certain third countries
pursuant to the invitation to tender issued in Regulation (EC)
No 2032/2004 is hereby fixed on the basis of the tenders
submitted from 20 to 23 June 2005 at 57,00 EUR/t.

Article 2

This Regulation shall enter into force on 25 June 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 June 2005.

For the Commission

Mariann FISCHER BOEL
Member of the Commission

(1) OJ L 270, 21.10.2003, p. 96.
(2) OJ L 353, 27.11.2004, p. 6.
(3) OJ L 61, 7.3.1975, p. 25. Regulation as last amended by Regulation

(EC) No 1948/2002 (OJ L 299, 1.11.2002, p. 18).
Commission Regulation (EC) No 974/2005 of 24 June 2005 determining the extent to which applications lodged in June 2005 for import licences for certain pigmeat sector products under the regime provided for by Council Regulation (EC) No 774/94 opening and providing for the administration of certain Community tariff quotas for pigmeat and certain other agricultural products can be accepted
Date: 2005-06-24
Institutions: European Commission
Subjects: agricultural product, import licence, pigmeat, tariff quota, veterinary legislation

25.6.2005

EN

Official Journal of the European Union

L 165/5

COMMISSION REGULATION (EC) No 974/2005

of 24 June 2005

determining the extent to which applications lodged in June 2005 for import licences for certain
pigmeat sector products under the regime provided for by Council Regulation (EC) No 774/94
opening and providing for the administration of certain Community tariff quotas for pigmeat and
certain other agricultural products can be accepted

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

Having regard to Commission Regulation (EC) No 1432/94 of
22 June 1994 laying down detailed rules for the application in
the pigmeat sector of the import arrangements provided for in
Council Regulation (EC) No 774/94 opening and providing for
the administration of certain Community tariff quotas for
pigmeat and certain other agricultural products (1), and in
particular Article 4(4) thereof,

Whereas:

The applications for import licences lodged for the third
quarter of 2005 are for quantities less than the quantities
available and can therefore be met in full.

(1)

(2)

It is appropriate to draw the attention of operators to the
fact that licences may only be used for products which
comply with all veterinary rules currently in force in the
Community,

HAS ADOPTED THIS REGULATION:

Article 1

Applications for import licences for the period 1 July to
to Regulation (EC)

1.
30 September 2005 submitted pursuant
No 1432/94 shall be met as referred to in Annex I.

2.
For the period 1 October to 31 December 2005, appli-
cations may be lodged pursuant to Regulation (EC) No 1432/94
for import licences for a total quantity as referred to in Annex
II.

3.
Licences may only be used for products which comply
with all veterinary rules currently in force in the Community.

The quantity available for the following period should be
determined.

Article 2

This Regulation shall enter into force on 1 July 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 June 2005.

For the Commission

J. M. SILVA RODRÍGUEZ
Director-General for Agriculture and
Rural Development

(1) OJ L 156, 23.6.1994, p. 14. Regulation as last amended by Regu-

lation (EC) No 341/2005 (OJ L 53, 26.2.2005, p. 28).

L 165/6

EN

Official Journal of the European Union

25.6.2005

ANNEX I

Group No

1

Percentage of acceptance of import licences submitted for the
period 1 July to 30 September 2005

100,00

ANNEX II

Group

1

Total quantity available for the period 1 October to
31 December 2005

7 000,0

(t)
Prior notification of a concentration (Case COMP/M.3746 — Tetra Laval/SIG Simonazzi) Text with EEA relevance
Date: 2005-06-24
Institutions: European Commission
Subjects: economic concentration, merger control, packaging product, plastics industry, pulp and paper industry

24.6.2005

EN

Official Journal of the European Union

C 153/25

Prior notification of a concentration

(Case COMP/M.3746 — Tetra Laval/SIG Simonazzi)

(2005/C 153/11)

(Text with EEA relevance)

1.
On 17 June 2005, 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 Tetra Laval Nederland B.V. (‘Tetra Laval’, The Netherlands), acquires within the meaning of Article
3(1)(b) of the Council Regulation control of certain undertakings belonging to SIG Holding AG, namely
SIG Holding Italia S.p.A., SIG Simonazzi S.p.A., SIG Simonazzi Blowform S.p.A., SIG Simonazzi Germany
GmbH, SIG Simonazzi (Russia) O.o.o., SIG Simonazzi Ibérica S.A. and SIG Beverages Ltd., by way of
purchase of shares, as well as certain assets belonging to the following subsidiaries: SIG Simonazzi (India)
Pvt. Ltd., SIG Technology AG, SIG Simonazzi Mexico SA de CV, SIG Simonazzi (Pacific) Sdn Bhd, SIG
Beverages Services Mexico SA de CV, SIG Beverages do Brasil Ltda, SIG (China) Beverage Machinery Co.
Ltd and, SIG Beverages North America Inc.

2.

The business activities of the undertakings concerned are:

— for Tetra Laval: carton packaging systems for food (Tetra Pak), equipment

for milk production
(DeLaval) and packaging equipment and systems in particular stretch blow moulding machinery,
barrier technology and filling machines for PET and HDPE plastic bottles (Sidel);

— for SIG Target: development, manufacture and marketing machines for processing, aseptic and non
aseptic filling and final packaging of beverages in plastic (PET and HDPE), glass and can containers and
labeling equipment.

On preliminary examination, the Commission finds that the notified concentration could fall within

3.
the scope of Regulation (EEC) No 139/2004. However, the final decision on this point is reserved.

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

4.
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 (No (32-2) 296 43 01 or 296 72 44) or by post,
under reference number COMP/M.3746 — Tetra Laval/SIG Simonazzi to the following address:

European Commission
Directorate-General for Competition,
Merger Registry
J-70
B-1049 Brussels

(1) OJ L 24, 29.1.2004, p. 1.
Commission Regulation (EC) No 973/2005 of 24 June 2005 determining the extent to which applications lodged in June 2005 for import rights in respect of frozen beef intended for processing may be accepted
Date: 2005-06-24
Institutions: European Commission
Subjects: CCT duties, beef, food processing, frozen product, import, tariff quota

L 165/4

EN

Official Journal of the European Union

25.6.2005

COMMISSION REGULATION (EC) No 973/2005

of 24 June 2005

determining the extent to which applications lodged in June 2005 for import rights in respect of
frozen beef intended for processing may be accepted

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

available. Under

cations lodged relate to total quantities which exceed the
quantities
circumstances and
taking care to ensure an equitable distribution of the
available quantities,
it is appropriate to reduce propor-
tionally the quantities applied for,

these

Having regard to Council Regulation (EC) No 1254/1999 of 17
May 1999 on the common organisation of the market in beef
and veal (1),

HAS ADOPTED THIS REGULATION:

Article 1

Having regard to Commission Regulation (EC) No 716/2005 of
12 May 2005 opening and providing for the administration of
an import tariff quota for frozen beef intended for processing (1
July 2005 to 30 June 2006) (2), and in particular Article 5(4)
thereof,

Every application for import rights lodged in accordance with
Regulation (EC) No 716/2005 for the period 1 July 2005 to 30
June 2006 shall be granted to the following extent, expressed as
bone-in beef:

Whereas:

(a) 5,166817 % of

imports
intended for the manufacture of ‘preserves’ as defined by
Article 3(1)(a) of Regulation (EC) No 716/2005,

the quantity requested for beef

(1)

(2)

Article 3(1) of Regulation (EC) No 716/2005 fixes the
quantities of frozen beef intended for processing which
may be imported under special terms in the period from
1 July 2005 to 30 June 2006.

Article 5(4) of Regulation (EC) No 716/2005 lays down
that the quantities applied for may be reduced. The appli-

(b) 32,725815 % of the quantity requested for beef imports
intended for the manufacture of products as defined by
Article 3(1)(b) of Regulation (EC) No 716/2005.

Article 2

This Regulation shall enter into force on 25 June 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 June 2005.

For the Commission

J. M. SILVA RODRÍGUEZ
Director-General for Agriculture and
Rural Development

(1) OJ L 160, 26.6.1999, p. 21. Regulation as last amended by Regu-

lation (EC) No 1899/2004 (OJ L 328, 30.10.2004, p. 67).

(2) OJ L 121, 13.5.2005, p. 53.
Lifting by France of public service obligations on scheduled air services operated on the Le Havre — Rouen — Strasbourg, Saint-Brieuc — Paris, and Saint-Brieuc — Nantes routes   (Text with EEA relevance)
Date: 2005-06-24
Institutions: European Commission
Subjects: France, air transport, airline, services of general interest

C 153/24

EN

Official Journal of the European Union

24.6.2005

Lifting by France of public service obligations on scheduled air services operated on the Le Havre
— Rouen — Strasbourg, Saint-Brieuc — Paris, and Saint-Brieuc — Nantes routes

(2005/C 153/10)

(Text with EEA relevance)

France has decided to lift the public service obligations imposed on scheduled air services operated
between:

1. Le Havre and Strasbourg via Rouen, published in the Official Journal of the European Communities C 279
of 25 September 1996 and amended on 16 April 1998 (Official Journal of the European Communities
C 116).

2. Saint-Brieuc and Paris, published in the Official Journal of the European Union C 53 of 7 March 2003.

3. Saint-Brieuc and Nantes, published in the Official Journal of the European Communities C 34 of 9 February

1999 and amended on 14 August 1999 (Official Journal of the European Communities C 233).
Commission Regulation (EC) No 971/2005 of 24 June 2005 establishing the standard import values for determining the entry price of certain fruit and vegetables
Date: 2005-06-24
Institutions: European Commission
Subjects: citrus fruit, fruit vegetable, import price, perennial vegetable, pip fruit, stone fruit

25.6.2005

EN

Official Journal of the European Union

L 165/1

I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 971/2005

of 24 June 2005

establishing the standard import values for determining the entry price of certain fruit and
vegetables

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Commission Regulation (EC) No 3223/94 of
21 December 1994 on detailed rules for the application of the
fruit and vegetables (1), and in
import arrangements
particular Article 4(1) thereof,

for

Whereas:

standard values for imports from third countries,
in
respect of the products and periods stipulated in the
Annex thereto.

(2)

In compliance with the above criteria,
the standard
import values must be fixed at the levels set out in the
Annex to this Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 4 of Regu-
lation (EC) No 3223/94 shall be fixed as indicated in the Annex
hereto.

(1)

Regulation (EC) No 3223/94 lays down, pursuant to the
outcome of the Uruguay Round multilateral trade nego-
tiations, the criteria whereby the Commission fixes the

Article 2

This Regulation shall enter into force on 25 June 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 June 2005.

For the Commission

J. M. SILVA RODRÍGUEZ
Director-General for Agriculture and
Rural Development

(1) OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regu-

lation (EC) No 1947/2002 (OJ L 299, 1.11.2002, p. 17).

L 165/2

EN

Official Journal of the European Union

25.6.2005

to Commission Regulation of 24 June 2005 establishing the standard import values for determining the entry
price of certain fruit and vegetables

ANNEX

CN code

0702 00 00

0707 00 05

0709 90 70

0805 50 10

0808 10 80

0809 10 00

0809 20 95

0809 30 10, 0809 30 90

0809 40 05

Third country code (1)

Standard import value

(EUR/100 kg)

052
204
999

052
999

052
999

388
528
624
999

388
400
508
512
524
528
720
804
999

052
624
999

052
068
400
999

052
999

624
999

62,6
35,2
48,9

85,7
85,7

89,1
89,1

66,5
56,5
71,1
64,7

93,3
102,8
107,1
67,0
46,4
63,7
47,6
93,7
77,7

187,8
188,8
188,3

266,1
148,4
325,6
246,7

157,0
157,0

166,0
166,0

(1) Country nomenclature as fixed by Commission Regulation (EC) No 750/2005 (OJ L 126, 19.5.2005, p. 12). Code ‘999’ stands for ‘of

other origin’.