Any such additional data requested shall be the minimum necessary to complete such a risk assessment.

Information for the calculation of residue concentration is required as a basis for assessing the risk for man.

Bleeding risk should be taken into account when considering the risk benefit for individual patients.

For this purpose, the data required for the risk assessment and methodology to be applied should also be established.

• The need to assess the risk of TB in patients prior to treating with Remicade.

The employer shall obtain additional information which is needed for the risk assessment from the supplier or from other readily available sources.

This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.

The CHMP concluded as well that the risk of cutaneous malignancies should be assessed through case-control studies.

"risk management" means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options;

Information on the health effects after repeated inhalatory exposure is considered necessary, particularly for the risk assessment of the occupational setting.

The assessment of the risk of such attacks shall be the responsibility of the Commission Security Office after consultation, as necessary, with NSAs.

Practical guidelines for the determination and assessment of risk, and for their review and, if necessary, adjustment, shall be developed in accordance with Article 12(2).

Whereas it is appropriate that the applicant submit dossiers which contain information which is necessary to evaluate the risks that will arise from proposed uses of the product;

The classification and the containment and control measures identified in the risk assessment as required to adequately contain the GMM during the proposed operations, leads to the classification of the contained use activities into classes 1 to 4.

Additionally, the Committee emphasised the necessity of a clear expression and justification of all end points, data, assumptions and rationales used for risk assessment.

The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

These results can also be used for risk assessment studies, for new and existing chemicals, and appropriate testing strategies for these purposes are indicated in the corresponding guidance documents.

In its opinion(9) the Committee found for the M2 and M4 metabolites that the risk to non-target terrestrial organisms were not yet adequately assessed and also identified other degradation products for which the risk to non-target organisms needed further evaluation.

To coordinate the collection of data in the Member States required for risk assessment by the Scientific Committee for Food in response to unscheduled and urgent questions related to food contaminations.

If sequential tests of haemostasis indicate an uncontrolled or worsening coagulopathy that significantly increases the risk of bleeding, the benefits of continuing the infusion must be weighed against the potential increased risk of bleeding for that patient.

providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a medicinal product, particularly information concerning post-authorisation safety studies.

The Commission shall evaluate, in close cooperation with the Member States, the need to propose measures at Community level in order to prevent any unacceptable risks for human health and the environment within the Community.

The same applies to the information necessary to assess the tolerance of the product by the target species and the risks for man and the environment, which could result directly or indirectly from the use of the product.

It is necessary to introduce, where appropriate and on the basis of the conclusions of the risk assessment, post-market monitoring requirements for the use of genetically modified foods for human consumption and for the use of genetically modified feed for animal consumption.

The assessment identified a need to reduce those risks and, in its opinion of 6 and 7 March 2001, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) confirmed that conclusion.

Whereas the employer should assess any risk to the safety and health of workers arising from the presence of hazardous chemical agents at the workplace, in order to take the necessary preventive and protective measures set out in this Directive;

Whereas the elaboration and amendment of common rules concerning safety, health and hygiene at work require a scientific evaluation of risk at the place of work and of the measures that need to be implemented to protect against these risks;

Contracting Governments shall determine when a Declaration of Security is required by assessing the risk the ship/port interface or ship-to-ship activity poses to persons, property or the environment.

If the PEC/PNEC ratio is equal to or less than one, the risk characterization shall result that, at present, no further information and/or testing and no risk reduction measures beyond those which are being applied already are necessary.

Furthermore, knowledge of the composition and of the physico-chemical and biological properties of the excreted residues deriving from the additive will be indispensable to define the extent of the studies necessary for assessment of the risk of pollution of the environment.

Whereas the said review cannot be completed by 31 December 1998 because of the absence in many Member States of the exposure data needed to evaluate the risks to health and the environment of cadmium in fertilisers;

American foulbrood, except where the competent authority has assessed the risk to be negligible, issued a specific authorisation for use only in that Member State, and taken all other necessary measures to ensure no spread of that disease;

Studies on acute inhalational toxicity, skin and, where necessary, mucous membranes irritancy and also allergenic potential must be performed by appropriate tests for the assessment of possible risks associated with the handling of the additive.

Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/ risk and the lack of PK data under normal conditions of use of the product.

Failure to pass the activated sludge simulation biodegradability test would indicate potential for the release of the metabolites by sewage treatment, which may be considered, in general terms, as evidence of need for a more complete risk assessment.

As far as applicable, the specific safety precautions should reflect the results of such assessments according to the uniform principles and should be applied in particular in those cases where risk-mitigation measures are necessary to prevent unacceptable effects.

ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a medicinal product is answered fully and promptly, including the provision of information regarding the volume of sales or prescriptions for the medicinal product concerned;

Following concerns of a possible increased cardiovascular (CV) risk related to the use of the 90mg dose of etoricoxib, France considered that a review of the benefit/ risk profile of Arcoxia was needed.

whereas in accordance to the procedure laid down in Commission Recommendation 98/477/EC(6), concerning information necessary to support applications for the evaluation of the epidemiological status of countries with respect to transmissible spongiform encephalopathies, certain Member States and third countries submitted data necessary to allow assessment of their geographical risk;

In its opinions of 4 February 2000 and 31 October 2002, the Scientific Committee on toxicity, ecotoxicity and the environment (CSTEE) confirmed the conclusions of these assessments of pentaBDE and octaBDE on the need to reduce risks to protect the environment.

Safeguards for the protection of the interests of actual and potential investors are required in all Member States in order to enable them to make an informed assessment of such risks and thus to take investment decisions in full knowledge of the facts.

Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with Remicade is not established, the risk and benefits to the individual patients must be carefully reviewed and consideration should be given to discontinuation of therapy.

Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3:

For the evaluation of risk arising from residues, experimental data on levels of exposure to the residue may not be required where it can be justified, that the micro-organism and its metabolites are not hazardous to humans in the concentrations that could occur as a result of authorised use.

American foulbrood (Paenibacillus larvae larvae), except where the competent authority has assessed the risk to be negligible, issued a specific authorisation for use only in that Member State, and taken all other necessary measures to ensure no spread of that disease;

In view of the need for urgent measures to prevent an unacceptable degree of contamination of feedingstuffs and pending the results of the monitoring programme on clays and the risk assessment, the acceptable level of dioxins in kaolinitic clays should be restricted by way of precaution to the analytical limit of determination.

ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a veterinary medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions for the veterinary medicinal product concerned;

It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms or to the quality of water, soil and air and where their effects cannot be evaluated by the available results relating to the active substance.

However, it was noted that the indications, species and posology in SPCs of some of the authorised products were different and these therefore needed to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.

In the case of any activity likely to involve a risk of exposure to biological agents, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.