Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment.

For these surveys, in the case of tubers samples of both seed and other potatoes shall be taken, preferably from lots in store and subjected to official or officially supervised laboratory testing using the method set out in Annex I for the detection and diagnosis of the organism.

Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

Where the animal has been slaughtered and is no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the herd over 12 months old, show a titre lower than 30 IU of agglutination per ml.

After the relevant control programme referred to in Article 5 has been approved, food business operators must have samples taken and analysed to test for the zoonoses and zoonotic agents listed in Annex I, column 1, respecting the minimum sampling requirements set out in the following table.

The testing of progeny tubers, or of stem bases for non-tuber forming species, one normal cycle of vegetative growth after the testing referred to in point 1 and 2, is recommended.

When a specific control programme is in force, the results of testing should be forwarded to purchasers of animals.

The Member States shall prescribe that any experiment or test for research or development purposes involving the release into the environment of an unauthorized plant protection product may only be carried out after authorization for trial purposes has been granted and under controlled conditions and for limited quantities and areas.

The incidence of pyrogen testing, using extract C, shall be decided by the national control authority.

The way of administration of the test substance depends on the main exposure routes.

• You have taken H2 antagonists or antacids (relieves indigestion) on the same day of the test.

Member States shall ensure that all tissue establishments where activities of testing, processing, preservation, storage or distribution of human tissues and cells intended for human applications are undertaken have been accredited, designated, authorised or licensed by a competent authority for the purpose of those activities.

For Community comparative trials and tests lasting more than one year, the parts of the trials and tests following the first year should be authorised by the Commission without further reference to the Standing Committee on Propagating Material of Ornamental Plants, on condition that the necessary appropriations are available.

a description of the tests of 21A.127 and 21A.128, and the names of persons authorised for the purpose of 21A.130(a).

Control of these metals can be achieved either through process validation or release test.

Where the animals have been slaughtered and are no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the holding over 12 months old, show a titre lower than 30 IU of agglutination per ml.

An application for type-certification of large aeroplanes and large rotorcraft shall be effective for five years and an application for any other type-certificate shall be effective for three years, unless an applicant shows at the time of application that its product requires a longer period of time for design, development, and testing, and the Agency approves a longer period.

Sampling and testing procedures for Newcastle disease and avian influenza after importation

It is very useful to test sera that are inconclusive in the ELISA test.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific na

blood samples must be collected for serological testing from pigs in accordance either with the provisions laid down in the monitoring or eradication programmes or plans approved in the framework of Decision 90/424/EEC(1) or Directive 90/425/EEC(2), or, in the absence of these provisions, with the procedures established by the competent authority of the Member States.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.

Test conditions The rate of aerobic and/or anaerobic degradation in soil must be reported.

They shall also include rules relating to design and costing, the test, inspection and acceptance conditions for works and methods or techniques of construction and all other technical conditions which the contracting authority is in a position to prescribe, under general or specific regulations, in relation to the finished works and to the materials or parts which they involve.

where at least 99,8 % of bovine herds have been recognised as officially brucellosis-free for at least four years, the interval between checks may be extended to two years if all animals over 12 months of age are tested, or testing may be restricted to animals over 24 months of age if herds continue to be tested each year.

With regard to orphan medicinal products it also covers the purchase of studies already carried out or subscriptions from specialist research institutions and payments for testing and sampling by the official medicines control laboratory under the European Department for Quality of Medicines of the European Pharmacopoeia.

In the case referred to in point (b), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed company to which it belongs, unless it has been otherwise agreed between the seed company to which it belongs, the applicant for certification and the competent seed certification authority.

in the case of participation solely in respect of seed sampling or solely in respect of seed testing, the scope thereof,

• extraneous agents testing of raw materials are carried out according to the relevant requirements

the acceptance for official testing of pure-bred breeding male pigs or the use of their semen within the quantitative limits necessary for the tests for monitoring their performance and assessing their genetic value to be carried out in accordance with Decision 89/507/EEC by officially approved associations or organizations.

GMP compliance of the production system 2. Extraneous agents testing of raw materials 3. Extraneous agents testing of batches of finished product, if required.

the verification process the institution uses to evaluate back-testing that is conducted to assess the model's accuracy.

Commission Decision 2002/756/EC of 16 September 2002 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC(7) is to be incorporated into the Agreement.

The campaigns may include the financial participation of Member States in the costs of recovering, managing and disposing of the sources and may also include surveys of historical records of authorities, such as customs, and of holders, such as research institutes, material testing institutes or hospitals.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.

- Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,

With regard to the potential benefit or otherwise from conducting additional tests, it is known that the efficiency of final batch testing in revealing defects is highly variable, depending on the type of defect, and that it is preferable to build quality into the whole process rather than rely on end product testing. No scientific arguments are available concerning how the additional testing would minimise the risk of possible seroconversion induced by the vaccine. On the contrary it is known that extremely high numbers of samples must be tested in order to detect a low level of defects.

Certification as certified seed may only occur if this is requested by the applicant for certification with the agreement of the breeder and if an official post-control test based on samples taken officially and carried out at the latest during the growing season of the entered seed shows that the seeds from the previous generation have met the requirements for basic seed in respect of varietal identity and purity.

For Community comparative trials and tests lasting more than one year, the parts of the trials and tests following the first year should be authorised by the Commission without further reference to the Standing Committee on Propagating Material and Plants of Fruit Genera and Species, on condition that the necessary appropriations are available.

That proportion shall be at least 7 % in the case of seeds of cereals and 10 % in the case of seeds of other species.

The test method and the method to validate test results must be provided by the approved body.

Furthermore, the sorafenib batch tested in the standard genotoxicity battery included 0.34 % PAPE.

Commission Decision of 18 December 2003 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants of agricultural and vegetable species and vine under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC for the years 2004 and 2005

during tests in the field, persist in soil for more than one year (i.e. DT90 > 1 year and DT50 > 3 months), or

Breakpoints Minimum inhibitory concentration (MIC) breakpoint established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for Staphylococci and Streptococci (except S. pneumoniae) are Susceptible ≤ 1 mg/ l and Resistant > 1 mg/ l.

Certification as certified seed may only occur if this is requested by the applicant for certification with the agreement of the breeder and if an official post-control test based on samples (1)OJ No 125, 11.7.1966, p. 2309/66. taken officially and carried out at the latest during the growing season of the entered seed shows that the seeds from the previous generation have met the requirements for basic seed in respect of varietal identity and purity.

Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.

If official or officially supervised laboratory testing using the method set out in Annex I confirms the presence of the organism in a sample of tubers, plants, or parts of plants, the responsible official bodies of a Member State, having regard to sound scientific principles, the biology of the organism and the particular production, marketing and processing systems in that Member State shall:

The competent authority of the Member State concerned shall ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples, that the legal requirements governing medicinal products are complied with.

Certification as certified seed may only occur if this is requested by the applicant for certification with the agreement of the breeder and if an official post-control test based on samples taken officially and carried out at the latest during the growing season of the entered seeds shows that the seeds from the previous generation have met the requirements for basic seed in respect of varietal identity and purity.