Clinical trials must always be preceded by adequate pharmacological and toxicological tests, carried out on animals in accordance with the requirements of Module 4 of this Annex.

Should unexpected results occur during the course of the trials, further preclinical toxicological and pharmacological tests must be undertaken and reviewed.

IT SHALL BE AT LEAST EQUAL TO 75 % OF THE AVERAGE OF THE BREAKING LOADS DETERMINED DURING TESTS ON UNABRADED STRAPS , AND NOT LESS THAN THE MINIMUM LOAD SPECIFIED FOR THE ITEMS BEING TESTED.

If no cytotoxicity is found in both parts of the experiment (- UVA and + UVA), testing with a great intercept between single doses up to the highest concentration is sufficient.

The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned.

During the EEC type-approval testing of a vehicle the technical inspection authority shall verify conformity with the requirements contained in the present Appendix and carry out any further tests considered necessary to this end.

Whereas these conditions have to take into account new developments in the testing methods for diseases of potato and new information on organisms harmful to potato, for which a test is necessary in order to detect their presence;

testing of blood/plasma donations and pools for infectious agents, including information on test methods and, in the case of plasma pools, validation data on the tests used.

The competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned.

The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of every instrument, as specified in paragraph 3.5.

The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the medicinal product concerned.

Assessment and verification: The applicant shall provide a test report stating that the number of switch on/off cycles for a CFL has been determined using a rapid cycle test (0,5 minute on, 4,5 minutes off) and the test procedures for lifetime referred to in EN 50285.

the format and contents of the request referred to in paragraph 2 as well as the documentation to be submitted to support that request, on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure;

This Decision is a first step towards phasing out completely the obligation to test for hormones each consignment selected for physical checks, and the Decision will be reviewed on the basis of future test results.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the product with the requirements of the directive either by examination and testing of every product as specified in point 4 or by examination and testing of products on a statistical basis, as specified in point 5, at the choice of the manufacturer (23)(). 3a.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the appliance to the requirements of this Directive by examination and testing of every appliance, as specified in point 5.4, or by examination and testing of appliances on a statistical basis, as specified in point 5.5, at the choice of the manufacturer.

Equivalent methods of testing shall be permitted provided that the results specified in items 6.1, 6.2 and 6.3 can be obtained either entirely by means of the substitute test or by calculation from the results of the substitute test.

Testing should be performed by appropriately accredited laboratories or laboratories that meet the general requirements expressed in standard EN ISO 17025 and are competent to perform the relevant tests.

All tests referred to in Articles 3 and 4 and in Annexes II, III, IV and VIII shall be conducted in compliance with the standards mentioned in Annex I.1 and in accordance with testing requirements under Article 10(5) of Regulation (EEC) No 793/93.

The notified body must carry out the appropriate examinations and tests in order to check that the product complies with the requirements of the international instruments either by examination and testing of every product as specified in point 4 or by examination and testing of products on a statistical basis, as specified in point 5, at the choice of the manufacturer.

The Administration shall require a test of a prototype division to ensure that it meets the above requirements for integrity and temperature rise in accordance with the IMO Fire Test Procedures Code.

The Administration shall require a test of a prototype division to ensure that it meets the above requirement for integrity and temperature rise in accordance with the IMO Fire Test Procedures Code.

Conducting the necessary studies, tests and trials with a view to the application of paragraphs 1 to 5 and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products.";

Assessment and verification: The applicant shall provide a test report stating that the colour rendering index of the light bulb has been determined using the test procedure referred to in CIE-standard/publication 29/2.

The Administration shall require a test of a prototype bulkhead or deck to ensure that it meets the above requirements for integrity and temperature rise in accordance with the IMO Fire Test Procedures Code.

2.2.5.The side chosen for application of the first impact on the rear of the structure (in the case of dynamic tests) or the first load on the rear of the structure (in the case of static tests) must be that which, in the opinion of the testing authorities, will result in the application of the series of impacts or loads under the most unfavourable conditions for the structure.

the following subparagraph shall be added:"The documents and information concerning the results of the pharmaceutical and pre-clinical tests and the clinical trials referred to in point (i) of the first subparagraph shall be accompanied by detailed summaries in accordance with Article 12.";

When fewer than 20 test and 10 control guinea pigs have been used, and it is not possible to conclude that the test substance is a sensitiser, testing in additional animals to give a total of at least 20 test and 10 control animals is strongly recommended.

The applicant shall provide a declaration of compliance with this criterion together with the relevant material safety data sheet or test report which shall indicate the test method, threshold and conclusion stated, using the following test methods:

testing, issuing and acceptance of test reports, performance of required technical evaluation and certification of compliance with the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Annex,

Notwithstanding the requirements of item 2.1.1 of Annex III, the technical department responsible for checking conformity of production may, with the consent of the manufacturer, carry out tests of Types I, II and III on vehicles which have been driven less than 3 000 km."

In particular, those Member States which have a homeopathic tradition should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products provided that they notify them to the Commission.

Assessment and verification: The applicant shall provide a test report stating that the energy efficiency, lifetime and lumen maintenance of the light bulb have been determined using the test procedures referred to in EN 50285.

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex;

The maximum torque and the maximum net power of an engine during a production conformity test may differ by ± 20 % of the values determined in the component type-approval test if the power measured is ≤ 1 kW and ± 10 % if the power measured is >

The maximum torque and the maximum net power of an engine during a production conformity test may differ from the values determined in the component type-approval test by ± 10 % if the power measured is ≤ 11 kW and ± 5 % if the power measured is >

The maximum torque and the maximum net power of an engine during a production conformity test may differ by ± 10 % from the values determined in the component type-approval test if the power measured is ≤ 11 kW and ± 5 % if the power measured is >

Where testing or sampling is required that is not covered by these methods and sampling techniques, the competent body or bodies assessing the application (hereinafter referred to as the "competent body") shall indicate which testing and/or sampling methods it considers acceptable.

Whereas Decision 94/611/EC refers in Table 1 of its Annex to the 'Single Burning Item` (SBI) test which is required for the testing of products for walls and ceilings including their surface coverings, building elements, products incorporated within building elements, pipes and duct components and products for façades/external walls in classes B, C or D;

The maximum torque and the maximum net power of an engine during a production conformity test may differ by ± 20 % of the values determined in the component type-approval test if the power measured is ≤ 1 kW and ± 10 % if the power measured is > 1 kW.

The maximum torque and the maximum net power of an engine during a production conformity test may differ by ± 10 % from the values determined in the component type-approval test if the power measured is ≤ 11 kW and ± 5 % if the power measured is > 11 kW.

When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both.

Directive 2001/83/EC(4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type as described in the EC type-examination certificate and with the requirements of the TSI by examination and testing of every subsystem, manufactured as a serial product, as specified under point 4.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the EC type-examination certificate and with the requirements of Directive 96/48/EC and of the TSI either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of interoperability constituents on a statistical basis, as specified in point 5, at the choice of the manufacturer.

The maximum torque and the maximum net power of an engine during a production conformity test may differ from the values determined in the component type-approval test by ± 10 % if the power measured is ≤ 11 kW and ± 5 % if the power measured is > 11 kW. Sub-Appendix 1

In the case of new medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide references relating to each individual constituent.

However, where the medicinal product is intended for a different therapeutic use from that of the other medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate toxicological and pharmacological tests and/or of appropriate clinical trials must be provided.

For the purpose of equipment testing (including interoperability tests) the European certification authority shall generate a different single European test key pair and at least two Member State test key pairs, the public keys of which shall be certified with the European private test key.

Standards and protocols for the performance of tests and trials on medicinal products are an effective means of control of these products and hence of protecting public health and can facilitate the movement of these products by laying down uniform rules applicable to tests and trials, the compilation of dossiers and the examination of applications.