This Agreement covers also documents that are not based on consensus.

The report and the opinion shall be submitted to the Standing Committee, which shall attempt to find a consensus between the two documents.

The current document is the result of the consensus reached by that group.

The report and the opinion shall be submitted to the Standing Committee, which shall attempt to find a consensus between the two documents.

The Contracting Parties shall adopt, by consensus, and make available to the public a document addressing issues discussed and conclusions reached during a meeting.

Unless specific definitions are given, the definition of terms in the "OECD principles of good laboratory practice" (Annex II to OECD Council Decision (C(81)30(final)), the "Guides for compliance monitoring procedures for good laboratory practice" (Annex I to Council Decision-Recommendation (C(89)87(final)), the "Application of the good laboratory practice principles to field studies" (GLP consensus document, OECD series on principles of good laboratory practice and compliance monitoring), and all amendments made thereto shall apply.

For the purpose of this Sectoral Annex, any term, unless otherwise defined in this Agreement, has the meaning assigned to it in the 'OECD Principles of good laboratory practice' as contained in Annex II of the OECD Council Decision of 12 May 1981 (C(81)30(final)), the 'Guides for compliance monitoring procedures for good laboratory practice' as contained in Annex I of the OECD Council Decision - Recommendation of 2 October 1989 (C(89)87(final)), the GLP Consensus Document 'The Application of the GLP Principles to Field Studies' (OECD Series on Principles of good laboratory practice and compliance monitoring, Number 6), and all amendments made thereto.

Further clarification of many of the points in this part of the Annex may be obtained by referring to the OECD consensus documents on GLP (on, e. g., the role and responsibilities of the study director).

Commission Recommendation of 4 April 2001 on the principles for out-of-court bodies involved in the consensual resolution of consumer disputes (Text with EEA relevance) (notified under document number C(2001) 1016)

(3) Within the framework of the International Conference on Harmonisation (ICH) a consensus was reached in 2000 to provide a harmonised format and terminology for a Common Technical Document through which a homogeneous organisation and presentation of a marketing authorisation application dossier for human medicinal products could be achieved.

Unless specific definitions are given, the definition of terms in the 'OECD Principles of Good Laboratory Practice' as revised in 1997 [ENV/MC/CHEM(98)17] based on OECD Council Decision of 12 May 1981 C(81)30(Final)] amended on 26 November 1997 [C(97) 186 FINAL], as well as Council Decision- Recommendation of 2 October 1989 [C(89)87(Final)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply.

Unless specific definitions are given, the definition of terms in the "OECD Principles of Good Laboratory Practice" [Appendix II to OECD Council Decision of 12 May 1981 C(81)30(Final)], the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice" [Appendix I to Council Decision-Recommendation of 2 October 1989 C(89)87(Final)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply.

This Framework Agreement shall enter into force on 1 September 1998, be expressed in language consistent with the Arrangement and issued as a TD/CONSENSUS document.

This document may be modified by consensus of the Participants.

The treating physician is referred to national and / or international consensus documents regarding treatment of anthrax

The treating physician should refer to national and /or international consensus documents regarding treatment of anthrax.

Treating physicians should refer to national and /or international consensus documents regarding the treatment of anthrax.

Physicians are recommended to follow current national and/ or international consensus documents regarding the treatment of anthrax.

For the purpose of this Sectoral Annex, any term, unless otherwise defined in this Agreement, has the meaning assigned to it in the "OECD Principles of good laboratory practice" as contained in Annex II of the OECD Council Decision of 12 May 1981 (C(81)30(final)), the "Guides for compliance monitoring procedures for good laboratory practice" as contained in Annex I of the OECD Council Decision - Recommendation of 2 October 1989 (C(89)87(final)), the GLP Consensus Document "The Application of the GLP Principles to Field Studies" (OECD Series on Principles of good laboratory practice and compliance monitoring, Number 6), and all amendments made thereto.

Further clarification of many of the points in this part of this Annex may be obtained by referring to the OECD consensus documents on GLP (on, e.g., the role and responsibilities of the study director).

Within the framework of the International Conference on Harmonisation (ICH) a consensus was reached in 2000 to provide a harmonised format and terminology for a Common Technical Document through which a homogeneous organisation and presentation of a marketing authorisation application dossier for human medicinal products could be achieved.

To this end, as early as possible and no later than 1 March 1997 each participant shall provide all other participants a document containing (a) the details concerning how the appropriate duty treatment will be provided in its WTO schedule of concessions, and (b) a list of the detailed HS headings involved for products specified in Attachment B. These documents will be reviewed and approved on a consensus basis and this review process shall be completed no later than 1 April 1997.

The scope of the referral was to address the safety and efficacy of cefuroxime axetil in uncomplicated gonorrhoea (cervicitis and urethritis) and to conclude on the risk-benefit balance for this sought indication The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee. the CHMP has recommended by consensus that the indication pertaining uncomplicated gonorrhoea (cervicitis and urethritis) should not be included in the product information.

The participants accepted the results of the review process described in paragraph 2 of the Annex to the Declaration, as reflected in the documents attached hereto, which were submitted by participants and have been reviewed and approved on a consensus basis.

These documents will be reviewed and approved on a consensus basis and this review process shall be completed no later than 1 April 1997. As soon as this review process has been completed for any such document, that document shall be submitted as a modification to the schedule of the participant concerned, in accordance with the Decision of 26 March 1980 on Procedures for Modification and Rectification of Schedules of Tariff Concessions (BISD 27S/25).