In Article 83, the words 'without prejudice to the powers of the transport section of the Economic and Social Committee.` shall be replaced by 'without prejudice to the powers of the Economic and Social Committee.`.

Lastly, as regards herbal medicinal products, this responsibility should be vested in the Committee on Herbal Medicinal Products set up under Directive 2001/83/EC.

The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121 of Directive 2001/83/EC and by the Standing Committee on Veterinary Medicinal Products set up by Article 89 of Directive 2001/82/EC.

However, the provisions of Articles 82 and 83 concerning the setting up of the Advisory Committee, shall enter into force on the day of publication of the implementing regulation referred to in Article 97.

When adopting its opinion, the Committee for Medicinal Products for Human Use shall include a proposal concerning the criteria for the prescription or use of the medicinal products in accordance with Article 70(1) of Directive 2001/83/EC.

The same shall apply where a Member State or the Commission considers that one of the measures envisaged in Titles IX and XI of Directive 2001/83/EC should be applied in respect of the medicinal product concerned or where the said Committee has delivered an opinion to that effect in accordance with Article 5 of this Regulation.

If the Commission considers that a person or undertaking has committed an infringement of this Treaty to which the provisions of Article 83 do not apply, it shall call upon the Member State having jurisdiction over that person or undertaking to cause sanctions to be imposed in respect of the infringement in accordance with its national law.

The consultation and disclosure of archive documents concerning the negotiations for the Treaties of Rome, the negotiations for the European Political Community and the Interim Committee for the Common Market and Euratom which have been lodged in the Community archives by Member States shall be permitted under the conditions laid down in Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 (1).

Where the supervisory authorities or the competent authorities of any other Member State are of the opinion that the manufacturer or importer established within the Community territory is no longer fulfilling the obligations laid down in Title IV of Directive 2001/83/EC, they shall forthwith inform the Committee for Medicinal Products for Human Use and the Commission, stating their reasons in detail and indicating the course of action proposed.

For the purposes of their integration into the Community system for the conservation and management of fishery resources established by Regulation (EEC) No 170/83, access of vessels flying the flag of Portugal to waters falling under the sovereignty or within the jurisdiction of the Kingdom of Spain covered by the ICES and the Fishery Committee for the Eastern Central Atlantic (CECAF) shall be subject until 31 December 1995 to the regime referred to in paragraphs 2 to 8, without prejudice to the specific provisions referred to in Article 155.

The Commission shall be assisted by the Committee set up by Article 5 of Directive 83/189/EEC.

The Commission shall be assisted by the Committee set up by Article 5 of Directive 83/189/EEC, hereinafter referred to as "the Committee".

(2) Annex IV to the Agreement was amended by Decision of the EEA Joint Committee No 83/2002 of 25 June 2002 fn.

amending Decision 83/471/EEC on the Community Inspection Committee on application of the classification scale for carcases of adult bovine animals

Commission Decision of 9 December 1997 amending Decision 83/247/EEC setting up a committee on Community policy regarding forestry and forestry-based industries

amending Decision 83/471/EEC relating to the Community Inspection Committee on the application of the classification scale for carcases of adult bovine animals

amending Decision 83/47 I/EEC relating to the Community Inspection Committee on the application of the classification scale for carcases of adult bovine animals

whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC;

Commission Decision of 24 June 1992 amending Decision 83/471/EEC on the Community Inspection Committee on application of the classification scale for carcases of adult bovine animals

Commission Decision of 27 July 1993 amending Decision 83/471/EEC relating to the Community Inspection Committee on the application of the classification scale for carcases of adult bovine animals

Commission Decision of 11 March 1986 amending Decision 83/471/EEC relating to the Community Inspection Committee on the application of the classification scale for carcases of adult bovine animals

Commission Decision of 23 April 1998 amending Decision 83/471/EEC relating to the Community Inspection Committee on the application of the classification scale for carcases of adult bovine animals

Whereas Commission Decision 83/471/EEC (2) laid down detailed rules for the conduct of on-the-spot inspections by the Community Inspection Committee referred to in Article 5 of Regulation (EEC) No 1208/81;

The mandates to be given to these organizations shall be referred for agreement to the Committee provided for under Article 5 of Directive 83/189/EEC in accordance with the procedures of the said Directive.

In the light of the opinion of the committee, and after consultation with the committee set up under Directive 83/189/EEC where it concerns harmonized standards, the Commission shall inform Member States if the standards or approvals concerned should be withdrawn in the publications referred to in Article 7 (3),

The Commission shall periodically inform the Advisory Committee on Safety, Hygiene and Health Protection at work of any activities arising from the implementation of this Decision, with the exception of any aspects deemed confidential by the Member States, and, where appropriate, the Standing Committee set up pursuant to Article 5 of Directive 83/189/EEC.

whereas Commission Decision 83/471/EEC of 7 September 1983 relating to the Community Inspection Committee for application of the classification scale for carcases ad adult bovine animals (3), as last amended by Decision 86/131/EEC (4), should be amended accordingly;

Where a Member State or the Commission considers that the standards referred to in Article 5 (1) do not entirely meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the standing committee set up under Directive 83/189/EEC, hereinafter referred to as 'the committee', giving the reasons therefore.

The Commission shall coordinate the activities of these Committees with the Committee provided for in Article 5 of Directive 83/189/EEC in particular where there is a potential overlap in issuing requests to European standards institutions under this Decision and that Directive.

Where a Member State or the Commission is of the opinion that the harmonized standards referred to in Article 5 do not fully meet the essential requirements referred to in Article 3, the Commission or the Member State shall notify the committee set up under Directive 83/189/CEE, setting out its reasons.

Where a Member State or the Commission considers that the harmonized standards referred to in Article 4 do not fully satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up by Directive 83/189/EEC, giving its reasons.

Whereas to follow the line of the revision of Regulation (EEC) No 918/83 it seems essential to abolish the expensive and complicated procedure involving in certain cases a decision by the Commission after consultation of a group of experts of all the Member States, meeting within the framework of the Committee on Duty Free Arrangements;

Should a Member State or the Commission consider that the harmonized standards referred to in Article 5 do not completely satisfy the relevant basic requirements referred to in Article 3, the Commission or the Member State concerned shall refer the matter to the committee created pursuant to Directive 83/189/EEC (1), setting out its reasons.

Whereas, with a view to enabling the Commission to evaluate the results of inspections, provision should be made for the Member States to inform the Commission of the action taken regarding recommendations made by the Inspection Committee and appropriately to adjust Commission Decision 83/471/EEC of 7 September 1983 relating to the Community Inspection Committee on the application of the classification scale for carcases of adult bovine animals (3), as last amended by Decision 92/429/EEC (4);

Whereas, given the general and horizontal nature of the role played by the Standing Committee set up pursuant to Article 5 of Directive 83/189/EEC in Community standardization policy and, more particularly, its part in the preparation of standardization applications and the operation of the existing European standardization agreements, this Standing Committee is especially suited to the task of assisting the Commission in monitoring the conformity of harmonized standards throughout the Community;

Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards or technical specifications, the Commission, after consulting the parties concerned, shall bring the matter before the committee referred to in Article 19, as well as the committee set up under Directive 83/189/EEC in the case of shortcomings in a harmonized standard, within two months if the Member State which has taken the measures intends to uphold them, and shall start the procedures referred to in Article 5 (2).

In the particular case where the measures referred to in paragraph 1 are based on a shortcoming in the standards, the Commission shall first consult the parties concerned and then within two months bring the matter before the Standing Committee set up by Directive 83/189/EEC if the Member State which took the measures intends to maintain them and initiates the procedures referred to in Article 5.

For the purposes of this Directive, harmonized standards shall be the technical specifications adopted by GEN, Cenelec or both, on mandates given by the Commission in conformity with Directive 83/189/EEC on the basis of an opinion given by the Committee referred to in Article 19 and in accordance with the general provisions concerning cooperation between the Commission and these two bodies signed on 13 November 1984.

In order to ensure the quality of harmonized standards for products, the standards shall be established by the European standards organizations on the basis of mandates given by the Commission in accordance with the procedure laid down in Directive 83/189/EEC and, after consulting the committee referred to in Article 19, in accordance with the general provisions concerning cooperation between the Commission and these bodies signed on 13 November 1984.

Whereas the Joint Committee established by the Agreement between the European Economic Community and the Socialist Republic of Romania of 28 July 1980 ( fn ) met in Brussels on 9 and 10 December 1985; whereas, upon completion of its work, it recommended that, inter alia, new products should be inserted in the Annex to Council Regulation (EEC) No 3419/83 of 14 November 1983 laying down certain detailed rules for the implementation of the Agreement between the Community and Romania on trade in industrial products ( fn );

(5) The Commission has proposed a Directive modifying, inter alia, Directive 91/675/EEC, First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance fn as amended, Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance fn, and Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73/239/EEC, 79/267/EEC, 92/49/EEC, 92/96/EEC, 93/6/EEC and 93/22/EEC, and Directives 98/78/EC and 2000/12/EC of the European Parliament and the Council fn, to delete the advisory functions of the Insurance Committee.

The functioning of the committee shall be subject to Article 83 of the Treaty.

- The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as

- the Committee considered the referral made under Article 36(1) of Directive 2001/ 83/ EC, as

- The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended,

Annex IV to the Agreement was amended by Decision of the EEA Joint Committee No 83/2002 of 25 June 2002(2).

Decision of the EEA Joint Committee No 83/2002 of 25 June 2002 amending Annex IV (Energy) to the EEA Agreement