Considering that the international harmonisation of standards and technical regulations and guidelines for methods and procedures for the control and marking of precious metal articles is a valuable contribution to the free movement of such products;

(b) Reference to OECD test guideline or other test guideline or method.

This method is based on the OECD Test Guideline (1).

It may issue test guidelines pursuant to Article 56 (2).

The methods described are based on the OECD Test Guideline (1).

The majority of the methods described are based on the OECD Test Guideline (1).

(See the Test Guidelines for more information on this issue).

Relevant information can be found in the OECD Test Guidelines.

TEST GUIDELINES FOR ENERGY STAR OFFICE EQUIPMENT

The 'shake flask' method described is based on the OECD Test Guideline (1).

GUIDELINES FOR THE TESTING OF TRAPS AND RESEARCH ON THE ONGOING DEVELOPMENT OF TRAPPING METHODS

- that the technical examination has been conducted in accordance with the test guidelines issued, or general instructions given, pursuant to Article 56(2) of the Basic Regulation,

The conduct of any technical examinations shall be in accordance with test guidelines issued by the Administrative Council and any instructions given by the Office.

- the technical examination has been carried out in a manner consistent with the designations by the Administrative Council pursuant to Article 55(1) of the Basic Regulation, and has been conducted in accordance with the test guidelines issued, or general instructions given, pursuant to Article 56(2) of that Regulation and Articles 22 and 23 of this Regulation,

Suitable balances are e.g. a highly sensitive 2-arm electronic microbalance (8) or a highly sensitive moving coil instrument (see OECD Test Guideline 104, Edition 12.05.81),

In addition for trials conducted within the European Community, the marketing authorisation holder shall make any additional arrangements for archiving of documentation in accordance with the provisions of Directive 2001/20/EC and implementing detailed guidelines.

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22)."

(2) Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use fn is to be incorporated into the Agreement.

Decision on test guidelines

Reference to OECD test guideline or other test guideline or method.

This method is analogous to OECD TG 423.

This method is analogous to OECD TG 407.`ANNEX IV E

This method is analogous to OECD TG 419

Test guidelines establishing the conditions for the examinations of the varieties exist at international level.

Upon proposal of the President of the Office, the Administrative Council shall take a decision as to the test guidelines.

The 'shake flask` method described is based on the OECD Test Guideline (1).

that the technical examination has been conducted in accordance with the test guidelines issued, or general instructions given, pursuant to Article 56(2) of the Basic Regulation,

The Administrative Council shall take a decision by 27 October 1996 on the test guidelines referred to in Article 22 of this Regulation;

It is appropriate to ensure consistency between the CPVO test guidelines and the conditions for the varieties with a view to their acceptance into national catalogues of the Member States.

Pending the acceptance of specific guidelines at international level, the information required shall be generated using test guidelines accepted by the competent authority (e.g. USEPA guideline(1));

Additional information may be found in the references found in the OECD guidelines and the relevant literature published elsewhere.

During clinical trials, these changes were usually reversible when monitoring and discontinuation guidelines were followed.

Directive 72/180/EEC was amended by Directive 2002/8/EC to ensure consistency between the CPVO test guidelines and the conditions for examining the varieties with a view to their acceptance in the national catalogues of varieties of the Member States as far as CPVO test guidelines had been established.

In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational medicinal products intended for clinical trials with the following characteristics:

According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/ CHMP/ 021/ 97 Rev.

Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of PRODUCT NAME ; thus, no adjustment of dose is required.

the technical examination has been carried out in a manner consistent with the designations by the Administrative Council pursuant to Article 55 (1) of the Basic Regulation, and has been conducted in accordance with the test guidelines issued, on general instructions given, pursuant to Article 56 (2) of that Regulation and Articles 22 and 23 of this Regulation,

the President of the Office shall submit a proposal for such test guidelines by 27 April 1996, taking into account those examination reports which form part of the findings referred to in Article 116 (3) of the Basic Regulation.

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

According to their guidelines for medicines used to correct heart rhythm, the CHMP would need to assess the results of a trial comparing MULTAQ to an existing medicine before it can be granted a licence.

Test guidelines relating to the conditions for the examination of the varieties have been issued by the Administrative Council of the Community Plant Variety Office (CPVO) established by Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights(4), as last amended by Regulation (EC) No 1650/2003(5), in respect of certain species.

Labelling of the investigational medicinal products intended for trials of this nature should be subject to simplified provisions laid down in the good manufacturing practice guidelines on investigational products and in Directive 91/356/EEC.

The particulars to appear in at least the official language(s) of the Member State on the outer packaging of investigational medicinal products or, where there is no outer packaging, on the immediate packaging, shall be published by the Commission in the good manufacturing practice guidelines on investigational medicinal products adopted in accordance with Article 19a of Directive 75/319/EEC.

the species listed in Annex II shall comply with the test guidelines for the conduct of tests for distinctness, uniformity and stability of the International Union for the Protection of new Varieties of Plants (UPOV) listed in that Annex.

Without prejudice to Article 87 (4) of the Regulation, a technical verification of the protected variety shall be conducted in accordance with the test guidelines duly applied when the Community plant variety right was granted in respect of that variety.

The detailed guidelines on the documentation relating to the clinical trial, which shall constitute the master file on the trial, archiving, qualifications of inspectors and inspection procedures to verify compliance of the clinical trial in question with this Directive shall be adopted and revised in accordance with the procedure referred to in Article 21(2).

Most of these methods are developed within the framework of the OECD programme for Testing Guidelines, and should be performed in conformity with the principles of Good Laboratory Practice, in order to ensure as wide as possible "mutual acceptance of data".

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use(2) is to be incorporated into the Agreement.

Member States shall ensure that in respect of the species listed in Annexes I and II, the minimum requirements for carrying out the examinations in respect of trial design and growing conditions, as laid down in the test guidelines referred to in those Annexes, are fulfilled at the time of the examinations.

For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the "Guide to good manufacturing practice for medicinal products and for investigational medicinal products".