ddrg/super_eurlex huggingface dataset:
COUNCIL RESOLUTION of 20 December 1995 on generic medicinal products (95/C 350/06)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Whereas, in its resolution of 30 November 1995 on the integration of health protection requirements in Community policies, the Council considers that the Community must pay particular attention to the impact on health of action proposed in a number of areas, including free movement of goods;

Whereas action to improve understanding of and address the impact on human health of the free movement of goods, in particular the free movement of medicinal products, should form part of the Community's overall strategy for action in the field of public health;

Whereas matters concerning prices and public financing of medicinal products are the sole responsibility of Member States' authorities;

Whereas generic medicinal products can help bring greater transparency and competition to the market; whereas the use of such medicinal products can improve cost-effectiveness, as emphasized by the Commission in its communication to the Council and the European Parliament of 2 March 1994 on the outlines of an industrial policy for the pharmaceutical sector in the European Community;

Whereas, in its resolution of 19 November 1993 on public health policy after Maastricht, the European Parliament asks the Commission to look into whether it is possible to encourage greater use of generic medicinal products;

Whereas the non-proprietary names of generic medicinal products may make them more easily identifiable;

Whereas it would be very useful for Member States to know the situation regarding generic medicinal products, including branded generics,

CALLS on the Commission, in close cooperation with the Member States, to draw up, in the light of the guidelines in the Annex, a report concerning policy on generic medicinal products in the Member States of the European Union and in the other OECD countries, in particular the USA, Canada and Japan.

ANNEX

Aspects to be considered

1. Collation of existing provisions, including measures to promote the prescription and supply of generic medicinal products.

2. Collation of the technical requirements for the assessment of generic medicinal products, the conditions for registering them and the specific regulations making it easier to obtain marketing authorization for them.

3. Analysis of the impact on public health of price differentials for generic medicinal products as compared with patented products and of the market shares for generic medicinal products.

4. Collation of legislation applicable to the international trade.
DECLARATION BY THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE COMMISSION

of 6 March 1995

on the incorporation of financial provisions into legislative acts

(96/C 102/03)

(This text replaces and cancels the text published in OJ No C 293 of 8 November 1995)

THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE COMMISSION,

Whereas the Joint Declaration of 30 June 1982 (1) states: 'In order that the full importance of the budget procedure may be preserved, the fixing of maximum amounts by regulation must be avoided, as must the entry in the budget of amounts in excess of what can actually be expended`;

Whereas, according to a statement annexed to the Interinstitutional Agreement of 29 October 1993 (2), the budgetary procedure provisions should be reviewed 'at the Intergovernmental Conference scheduled for 1996 in order to achieve interinstitutional cooperation on a partnership basis`,

HEREBY DECLARE AS FOLLOWS:

1. Legislative acts concerning multiannual programmes adopted under the codecision procedure

These acts shall contain a provision in which the legislative authority shall lay down the financial framework for the programme for its entire duration.

That amount shall constitute the principal point of reference for the budgetary authority during the annual budgetary procedure.

The budgetary authority and the Commission, when drawing up its preliminary draft budget (PDB), undertake not to depart from this amount unless new, objective, long-term circumstances arise for which explicit and precise reasons are given.

2. Legislative acts concerning multiannual programmes not subject to the codecision procedure

These acts shall not contain an 'amount deemed necessary`.

Should the Council wish to include a financial reference, this shall be taken as illustrating the will of the leigislative authority and shall not affect the powers of the budgetary authority as defined by the Treaty. This provision will be mentioned in all acts which include such a financial reference.

If the amount concerned has been the subject of an agreement pursuant to the conciliation procedure provided for in the Joint Declaration of 4 March 1975 (3), it will be considered a reference amount within the meaning of point 1 of the present Declaration.

3. The financial statement provided for in Article 3 of the Financial Regulation shall reflect in financial terms the objectives of the proposed programme and include a schedule covering the duration of the programme. It shall be revised, where necessary, when the PDB is drawn up, taking account of the extent of implementation of the programme. The revised statement shall be forwarded to the budgetary authority together with the PDB.

(1) OJ No C 194, 28. 7. 1982, p. 1.

(2) OJ No C 331, 7. 12. 1993, p. 1.

(3) OJ No C 89, 22. 4. 1975, p. 1.
Information from the Commission - Nomination of members of the Consumer Committee



Official Journal C 036 , 02/09/1996 P. 0005 - 0005



Nomination of members of the Consumer Committee (96/C 36/06) The Consumer Committee was instituted by Commission Decision 95/260/EC of 13 June 1995 (1) By Decision of 24 January 1996, the Commission appointed the following as members and alternates of the Committee from 1 February 1996 for a period of two years: >TABLE> (1) OJ No L 162, 13. 7. 1995, p. 37.
ANNEX III.6

COUNCIL CONCLUSIONS of 20 June 1994 on the Commission communication on immigration and asylum policies

THE COUNCIL OF THE EUROPEAN UNION,

EXPRESSES its gratitude for the Commission communication of 23 February 1994 on immigration and asylum policies, which has the great merit of encompassing the various aspects of these policies;

NOTES that the various chapters of the Commission communication have been discusses by the General Affairs Council, the Social Affairs Council, the Development Council and, in accordance with the procedural decisions taken at its meeting on 23 March 1994, the preparatory bodies for the JHA Council;

RECALLS the exchange of views at the informal meeting of the Ministers for Internal Affairs in Salonika on 6 and 7 May 1994;

REITERATES the importance it attaches to the action plan and the priority work programme for 1994 which were adopted at the end of 1993;

CALLS upon the competent bodies to examine, at the time of preparation of a new work programme, the desirability of including in it the topics in that communication which come under Title VI of the Treaty on European Union but which are not included in the priority work programme for 1994.
REPORT OF THE EUROPEAN COURT OF AUDITORS on the financial statements of the European Coal and Steel Community on 31 December 1996

1. This report concerns the reliability of the accounts drawn up by the Commission in accordance with Article 45c of the Treaty establishing the European Coal and Steel Community.

2. The Court has audited the accounts and financial statements of the European Coal and Steel Community on 31 December 1996 in accordance with generally accepted auditing standards and carried out such checks as it considered necessary.

3. In the Court's opinion, the attached financial statements (balance sheet on 31 December 1996, profit and loss account, statement of the allocation of surplus and notes to the financial statements), which have been drawn up in accordance with generally accepted accounting principles, give a true and fair view of the assets and financial situation of the European Coal and Steel Community at 31 December 1996 and of the result of its operations for the year then ended.

Luxembourg, 24 June 1997.

Bernhard FRIEDMANN

President of the Court of Auditors

Armindo de SOUSA RIBEIRO

Member of the Court of Auditors
COUNCIL CONCLUSIONS of 17 February 1997 on the Green Paper on the protection of minors and human dignity in the audiovisual and information services (97/C 70/03)

After a presentation by the Commission and an exchange of views, the Council welcomes the Green Paper on 'the protection of minors and human dignity in the audiovisual and information services`.

The Council noted the specific importance of these matters linked to the content of the new audiovisual services. It takes note of the complementarity between this Green Paper and the Commission communication on 'illegal and harmful content on the Internet` in accordance with the resolution of the Council and of the representatives of the Governments of the Member States meeting within the Council adopted on 28 November 1996 which notes the need for consideration of both documents in greater detail. The Council also takes note of the timetable presented by the Commission, involving in-depth consultation of interested parties, on the basis of their observations on the Green Paper in the first half of 1997. It requests the Commission, insofar as Community competence is concerned, to follow up work on the Green Paper between now and the next meeting of the Council (audiovisual/culture), including proposing further initiatives if appropriate.
COMMISSION OPINION of 10 September 1997 concerning the plan for the disposal of radioactive waste from the Centraco nuclear treatment and conditioning plant (France) in accordance with Article 37 of the Euratom Treaty (97/C 291/04)

On 20 March 1997, the European Commission received from the French Government, in accordance with Article 37 of the Euratom Treaty, general data relating to the plan for the disposal of radioactive waste resulting from the operation of the Centraco nuclear treatment and conditioning plant.

On the basis of these data and after consulting the group of experts, the Commission has drawn up the following opinion:

1. The nearest point on the territory of another Member State, in this case Italy, is at a distance of 180 km, while the nearest point in Spain is 230 km from the plant.

2. The solid wastes arising from the operation of the Centraco plant are either to be recycled on site or treated in situ or ex situ. There will be no final storage of any waste on site.

3. Under normal operating conditions, the planned releases of liquid and gaseous effluents will give rise to an exposure of the population of other Member States which is not significant from the health point of view.

4. In the event of unplanned discharges of radioactive waste which may follow an accident of the type and magnitude considered in the general data, the doses liable to be received by the population of other Member States would not be significant from the health point of view.

In conclusion, the Commission is of the opinion that the implementation of the plan for the disposal of radioactive effluents arising from the operation of the Centraco plant, both in normal operation and in the event of an accident of the type and magnitude considered in the general data, is not liable to result in radioactive contamination, significant from the point of view of health, of the water, soil or airspace of another Member State.
14.

The strong presence of the parent companies in upstream or downstream markets is a factor to be taken into consideration in assessing the full-function character of a joint venture where this presence leads to substantial sales or purchases between the parent companies and the joint venture. The fact that the joint venture relies almost entirely on sales to its parent companies or purchases from them only for an initial start-up period does not normally affect the full-function character of the joint venture. Such a start-up period may be necessary in order to establish the joint venture on a market. It will normally not exceed a period of three years, depending on the specific conditions of the market in question (8). Where sales from the joint venture to the parent companies are intended to be made on a lasting basis, the essential question is whether, regardless of these sales, the joint venture is geared to play an active role on the market. In this respect the relative proportion of these sales compared with the total production of the joint venture is an important factor. Another factor is whether sales to the parent companies are made on the basis of normal commercial conditions (9). In relation to purchases made by the joint venture from its parent companies, the full-function character of the joint venture is questionable in particular where little value is added to the products or services concerned at the level of the joint venture itself. In such a situation, the joint venture may be closer to a joint sales agency. However, in contrast to this situation where a joint venture is active in a trade market and performs the normal functions of a trading company in such a market, it normally will not be an auxiliary sales agency but a full-function joint venture. A trade market is characterised by the existence of companies which specialise in the selling and distribution of products without being vertically integrated in addition to those which are integrated, and where different sources of supply are available for the products in question. In addition, many trade markets may require operators to invest in specific facilities such as outlets, stockholding, warehouses, depots, transport fleets and sales personnel. In order to constitute a full-function joint venture in a trade market, an undertaking must have the necessary facilities and be likely to obtain a substantial proportion of its supplies not only from its parent companies but also from other competing sources (10).
Composition of the European Advisory Committee on statistical information in the economic and social spheres (98/C 142/02)

In accordance with Decision 91/116/EEC of the Council of 25 February 1991, establishing a European Advisory Committee on statistical information in the economic and social spheres (CEIES) (1), and in particular Article 4 of the said Decision, the Commission, on 15 September 1997, appointed its four representatives on the CEIES:

>TABLE>

The Council, having consulted the Commission, appointed on 17 November 1997:

>TABLE>

The CEIES also includes:

1. the Chairman of the Committee on Monetary, Financial and Balance of Payments Statistics:

>TABLE>

2. the Presidents or Directors-General of the national statistical institutes of the Member States:

>TABLE>

(1) Decision 97/255/EC of the Council of 14 April 1997, amending Decision 91/116/EEC (OJ L 59, 6.3.1991, p. 21 and OJ L 102, 19.4.1997, p. 32).
OPINION OF THE EUROPEAN MONETARY INSTITUTE at the request of the Council of the European Union under Articles 106(6) and 109f(8) of the Treaty establishing the European Community (the Treaty) and Article 42 of the Statute of the ESCB on a proposal from the Commission for a Council Regulation (Euratom, ECSC, EC) amending Regulation (Euratom, ECSC, EEC) No 549/69 determining the categories of officials and other servants of the European Communities to whom the provisions of Article 12, the second paragraph of Article 13 and Article 14 of the Protocol on the privileges and immunities of the European Communities apply (98/C 190/08)

CON/98/17

1. The present opinion was requested in a letter dated 6 March 1998 from the Council of the European Union which, for this purpose, forwarded document COM(97) 725 final to the EMI. The document contained the proposal and its explanatory memorandum. The EMI is competent to deliver an opinion under Articles 106(6) and 109f(8) of the Treaty.

2. The Protocol on the privileges and immunities of the European Communities (the Protocol) is applicable to the ECB according to Article 40 of the Statute of the ESCB and Article 23 of the Protocol. The objective of the proposal is to define the applicability to ECB staff of Articles 12, 13(2) and 14 of the Protocol, according to which officials and other servants of Community institutions and bodies are in certain respects immune from legal proceedings, are not subject to formalities for the registration of aliens and have the right to import free of duty certain personal equipment, and which specify rules for the national tax regimen to which such officials and servants are subject (for taxes other than those on salaries).

3. The proposal suggests that a new Article 4a will replace the old Article 4a, which relates to the EMI, and that the Regulation should enter into force on the date on which the establishment of the ECB becomes effective. The EMI considers such a replacement to be problematical owing to the fact that, although it is true that the EMI will go into liquidation on the establishment of the ECB, its liquidation shall be completed by the beginning of the third stage. Until the end of the liquidation the ECB and the EMI (under liquidation) will coexist. In particular, EMI members of staff will continue to perform their tasks, working for the ECB under EMI contracts, until the expiry of such contracts or their replacement by ECB contracts. At the same time, new ECB members of staff will be hired under the terms of ECB contracts. Therefore, it is necessary to make provision for the old Article 4a, which relates to the EMI, to remain in force until the final day of the liquidation of the EMI, while the new Article 4a, which relates to ECB staff, must enter into force on the date on which the establishment of the ECB becomes effective.

4. This opinion will be published in the Official Journal of the European Communities.

Frankfurt, 6 April 1998
Information from the Commission - Appointment of members of the Consumer Committee



Official Journal C 133 , 13/05/1999 P. 0003 - 0003



Appointment of members of the Consumer Committee (1999/C 133/03) The Consumer Committee was set up by Commission Decision 95/260/EC of 13 June 1995(1). By its Decision of 5 May 1999, the Commission has appointed the following member and alternate member of the Consumer Committee, replacing the members previously appointed(2) for the remainder of their term of office: >TABLE> (1) OJ L 162, 13.7.1995, p. 37. (2) OJ C 93, 28.3.1998, p. 22.
Information from the Commission - Alphabetical list of the scientists appointed by the Commission as members of the Scientific Committees set up by Decision 97/579/EC



Official Journal C 376 , 28/12/1999 P. 0003 - 0004



Alphabetical list of the scientists appointed by the Commission as members of the Scientific Committees set up by Decision 97/579/EC(1) (1999/C 376/03) Scientific Committee on Animal Nutrition Dr Diana ANDERSON British Industrial Biological Association (BIBRA), United Kingdom Prof. J. KAMPHUES Tierärztliche Hochschule Hannover, Deutschland Derek William RENSHAW MAFF, Joint Food Safety and Standarts Group, United Kingdom Scientific Committee on animal health and welfare Prof Jos NOORDHUIZEN University Utrecht, Netherlands Scientific Committee on veterinary measures relating to public health Dr Antoine FLAHAULT Institut National de la Santé et de la Recherche Médicale, France Dr Peter GERNER-SMIDT Statens Serum Institut, Denmark Dr. Wolfgang PFAU Universität Hamburg, Deutschland Dr. Hilde KRÜSE National Veterinary Institute, Norge Prof. Jan B. M. VAN HOOF Universiteit Gent, België Scientific Committee on plants Herbert KÖPP Biologische Bundesanstalt für Land- und Forstwirtschaft, Deutschland Prof Kai SAVOLAINEN Finnish Institute of Occupational Health, Finland Dr Tom SHERRATT University of Durham, United Kingdom Dr Otto MEYER Danish Veterinary and Food Administration, Denmark Dr Angelo MORETTO Università degli Studi di Padova, Italia Scientific Committee on cosmetic products and non-food products intended for consumers Rémi GLOMOT Paris, France Dr D. P. O'MAHONY University College Cork, Ireland Scientific Committee on medical products and medical devices Dr. Arne Hensten PETTERSEN Nordisk Instituut for ordontolostik materialprovning, Scandinavian Institute of Dental Materials, Halsum, Norge Dr Philippe VANNIER Agence Française de Sécurité Sanitaire des Aliments, AFSSA, Ploufragan, France Scientific Committee on toxicity, ecotoxicity and environment Prof Peter CALOW The University of Sheffield, United Kingdom (1) See Decision 97/579/EC (OJ L 237, 28.8.1997, p. 18).
Commission Communication pursuant to Article 4(1)(a) of Council Regulation (EEC) 2408/92

Modification by the United Kingdom of a public service obligation in respect of a scheduled air service between Glasgow and Barra

(1999/C 355/04)

(Text with EEA relevance)

1. The United Kingdom has decided to modify the public service obligation in respect of the scheduled air service between Glasgow and Barra as set out in the notice published in the Official Journal of the European Communities No C 387 of 21 December 1996, page 6, pursuant to 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.

2. The modified public service obligation is as follows:

- Minimum frequencies

One return trip per day except Sundays between Glasgow and Barra.

- Capacity

The capacity of the aircraft used should be not less than:

- 11 seats on the Glasgow to Barra route and 14 seats on the Barra to Glasgow route (Mondays to Fridays); and

- nine seats on the Glasgow to Barra route and 14 seats on the Barra to Glasgow route (Saturdays).

(Provision is currently made by the present operator for two seats for the post office on all outbound services. This is, however, subject to separate contract arrangements).

- Aircraft types

The aircraft used should be suitable for landing on Barra airstrip which is located on Traigh Mhor beach.

- Fares

The price of a single ticket must not exceed GBP 97 (excluding air passenger duty).

The maximum fare on the route may be increased once every year with the prior written consent of the Scottish Ministers in line with the United Kingdom's Retail Price Index (all items) or any successor index to this.

No other changes may be made to the fare levels without the prior written consent of the Scottish Ministers.

The new maximum fare on the route must be notified to the Civil Aviation Authority and to the European Commission which may publish it in the Official Journal of the European Communities.