(ii) any country which does not proceed to an examination as to novelty, whether immediate or deferred, and in which the procedure for the grant of patents or other kinds of protection does not provide for a search into the state of the art, may declare that it does not undertake to include the symbols relating to the groups and subgroups of the Classification in the documents and notices referred to in paragraph (3).

The institutions may organise internal competitions for each function group on the basis of qualifications and tests for the institution concerned which shall be at grade AST 6-level or higher and at grade AD 9-level or higher.

Once every five years the European Parliament shall organise an internal competition on the basis of qualifications and tests for each function group which shall be at grade AST 6-level or higher and at grade AD 9-level or higher, in accordance with the conditions set out in the second subparagraph of paragraph 3.";

It is necessary to increase the fees charged to applicants for technical examinations and to introduce different fee groups.

The fee to be paid for the technical examination of a variety pursuant to Article 8 shall be determined, by reference to the year in which the growing period begins and to the species group to which the variety belongs, in accordance with the table:

The institutions may organise internal competitions for each function group on the basis of qualifications and tests for the institution concerned which shall be at grade AST 6-level or higher and at grade AD 9-level or higher.

Once every five years the European Parliament shall organise an internal competition on the basis of qualifications and tests for each function group which shall be at grade AST 6-level or higher and at grade AD 9-level or higher, in accordance with the conditions set out in the second subparagraph of paragraph 3.';

Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests.

Except for treatment with the test substance, animals in the control groups should be handled in an identical manner to the animals in the treated groups.

Except for treatment with the test substance, animals in the control groups should be handled in an identical manner to animals of the treatment groups.

Except for treatment with the test substance, animals in the control groups should be handled in an identical manner to animals in the treated groups.

The condition of a metabolic activation system may depend upon the class of chemical being tested.

The choice and condition of a metabolic activation system may depend upon the class of chemical being tested.

Except for treatment with the test substance, animals in the control group should be handled in an identical manner to the animals in the treated groups.

9 However, in clinical trials the related adverse events were numerically more frequent in the Xeomin group compared to the Botox group.

The use of chemical class-related positive control chemicals should be considered, when available.

12 None of the EPC trials mandated that treatment be withheld from patients in the placebo group until clinical progression.

individual weight of the animals at the start of the test, including body weight range, mean and standard deviation for each group.

individual weight of the animals at the start of the test, including body weight range, means and standard deviation for each group.

In addition, the use of chemical class-related positive control chemicals may be considered, when available.

Negative controls, consisting of solvent or vehicle alone, without test substance, and otherwise treated in the same way as the treatment groups, should be included.

ownership and maximum age of young bulls entering the station at the time of the test and the range of ages of contemporary bulls in the station,

whereas a new additive belonging to this group which allows absorption of caesium nuclides by animals to be substantially reduced has been successfully tested in certain Member States;

(cc) Each tuberculin under test shall be assayed against the appropriate standard tuberculin by an intradermal assay using groups of guinea-pigs suitably sensitized.

4/ How can the company rule out any role of bicalutamide 150 mg in the increased mortality due to heart failure in the Casodex arm of the EPC trial?

It is dependent on chemical class and there are carcinogens that are not detected by this test because they act through other, non-genotoxic, mechanisms or mechanisms absent in bacterial cells.

These trials were carried out in different risk groups and age categories, i. e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.

Correlation is dependent on chemical class and there is increasing evidence that there are carcinogens that are not detected by this test because they appear to act through mechanisms other than direct DNA damage.

Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and rat bone marrow micronucleus.

For the purposes of examination, the birds from each house must be grouped into batches of five and samples of liver, ovary and intestines taken from each bird in the batch must be examined for salmonella using analyses and tests recognized in accordance with the procedures laid down in Article 16 of this Directive or pending such recognition by tried and tested national methods.

Correlation is dependent on chemical class and there is increasing evidence that there are carcinogens that are not detected by this test because they appear to act through other, non-genotoxic mechanisms or mechanisms absent in bacterial cells (6).

Once every five years the European Parliament shall organise an internal competition on the basis of qualifications and tests for each function group which shall be at grade AST 6-level or higher and at grade AD 9-level or higher, in accordance with the conditions set out in the second subparagraph of paragraph 3.";

Overall, the in vitro characterisation of phenotypic cross-resistance between lopinavir and other protease inhibitors suggest that decreased susceptibility to lopinavir correlated closely with decreased susceptibility to ritonavir and indinavir, but did not correlate closely with decreased susceptibility to amprenavir, saquinavir, and nelfinavir.

The bacterial reverse mutation test may not be appropriate for the evaluation of certain classes of chemicals, for example highly bactericidal compounds (e.g. certain antibiotics) and those which are thought (or known) to interfere specifically with the mammalian cell replication system (e.g. some topoisomerase inhibitors and some nucleoside analogues).

Ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay using S. typhimurium and E. coli, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.

the trial subject or, when the person is not able to give informed consent, his legal representative has had the opportunity, in a prior interview with the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions under which it is to be conducted and has also been informed of his right to withdraw from the trial at any time;

The Agency ’ s inspection-related working parties will: harmonise inspection procedures and processes, in particular those relating to inspections of active substances and to pharmacovigilance; develop guidelines in light of the requirements of Community legislation on clinical trials and blood; and continue to work on GMP guidelines on products used as gene and cell therapies.

This appropriation is intended to cover expenditure arising from recruitment procedures, and in particular publication costs, travel costs and accident insurance for candidates called for examinations and interviews, costs directly linked to the promotion and organisation of group recruitment tests (hire of rooms, furniture, machines and miscellaneous equipment, fees for the preparation and correction of tests, etc.), as well as pre-recruitment medical examinations.

11 Gamma Butyrolactone (GBL), a pro-drug of GHB tested at exposures similar to the expected in man (1.21-1.64 times) has been classified by NTP as non-carcinogenic in rats and equivocal carcinogen in mice, due to slight increase of pheochromocytomas which was difficult to interpret due to high mortality in the high dose group.