Safety evaluation for the human consumer

Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up.

Safety evaluation of Tarceva is based on the data from 759 patients treated with at least one 150 mg dose of Tarceva monotherapy during Phase III NSCLC study BR.21, Phase II NSCLC study A248-1007, and three Phase II studies in populations other than NSCLC:

Evaluation of risk management in the field of foodstuff/food safety.

Regulatory procedures for the safety, safeguards, physical security, waste management, radiological safety, and environmental impact evaluation of nuclear facilities.

f. Regulatory procedures for the safety, safeguards, waste management, and environmental impact evaluation of nuclear facilities.

d) Evaluation of events with major safety significance such as serious operating incidents that are of immediate interest to the Parties,

The evaluation of risk analyses or of safety studies for hazardous activities and an action plan for the implementation of necessary measures;

b) Regulatory procedures and assessment methodologies related to nuclear safety, radiation protection, quality assurance, waste management, transportation, emergency planning, environmental impact evaluation of nuclear facilities,

The European Union ascribes particular importance to food safety, which is manifest in the establishment of a particular European Commission Directorate General (DG SANCO), creation of the European Food Safety Authority (EFSA) as the central institution to carry out the processes of risk evaluation, modernization and unification of regulations governing the risk management and efficient risk communication.

-safety evaluation (prepared by Krsko NPP),

Besides all the design and design calculation aspects these documents include the safety evaluation screening and safety evaluation.

According to the results of the safety evaluation this is, in practise not possible at Krško.

After the documentation package is submitted, the process of regulatory review, safety evaluation and decision making is officially started by the SNSA.

Before the proposed modification is implemented or submitted for approval to the SNSA, the safety evaluation has to be approved by the KOC (board of experts from the Krsko NPP personnel) and the KSC (board of external experts).

It should be mentioned here that the safety evaluations are aimed primarily at the assessment of potential safety consequences of the proposed modification.

On request, Krsko NPP also submits to the SNSA the safety evaluations of plant changes, which have no impact on the SAR.

The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the medicinal product.

The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.

A new additive may always be added to the list of substances referred to in Article 4(1) following an evaluation of its safety by the Authority.

Submittalls of proposed plant changes, which have an impact on the SAR, are also always accompanied by the safety evaluations prepared by the staff of Krsko NPP.

coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorisation procedures;

The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned.

The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned.

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.

As most of the SGR activities are performed after shutdown of the plant with an unloaded core, safety evaluations for nuclear risk deal mainly with the requirement that the fuel in the spent fuel pool is not a danger.

For additives which are already placed on the market in one or more of the Member States, sufficient time should be allowed for the submission of the data necessary for the Authority to carry out an evaluation of their safety.

The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with Regulation (EEC) No 2377/90 may be used in an appropriate manner as literature, particularly for the safety tests.

By way of derogation from paragraph 1, the monomers and other starting substances listed in Annex II, section B may continue to be used until 31 December 2004 at the latest, pending their evaluation by the European Food Safety Authority (hereinafter referred to as the Authority)."

the explosion protection document includes the identification of the hazards, the evaluation of risks and the definition of the specific measures to be taken to safeguard the health and safety of workers at risk from explosive atmospheres, in accordance with Article 9 of Directive 89/391/EEC;

Member States shall provide that any person interested in the inclusion in the list referred to in Article 4(1) of an additive, which is already placed on the market in one or more of the Member States, shall submit data for the evaluation of its safety by the Authority by 31 December 2006 at the latest.

providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a veterinary medicinal product, particularly information concerning post-authorisation safety studies, including information regarding the validity of the withdrawal period or lack of expected efficacy or potential environmental problems.

The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.

Such tasks shall include the collection, recording and evaluation of technical data in the fields of maritime safety, maritime security and maritime traffic, as well as in the field of marine pollution, both accidental and deliberate, the systematic exploitation of existing databases, including their cross-fertilisation, and, where appropriate, the development of additional databases.

Only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards, should marketing authorisation be granted by the Community, and this should be done by means of a rapid procedure ensuring close cooperation between the Commission and Member States.

It is thus necessary to subject such products to an environmental risk-assessment procedure similar to the procedure under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(13), to be conducted in parallel with the evaluation, under a single Community procedure, of the quality, safety and efficacy of the product concerned.

- Adventitious Agents Safety Evaluation

to prepare reports for the safety evaluation of chemically defined flavouring substances according to the evaluation programme referred to in Article 4 of Regulation (EC) No 2232/96,

Where applicable, information regarding the manufacturing sites and the adventitious agents, safety evaluation shall be provided.

Commission Recommendation 80/1089/EEC of 11 November 1980 concerning tests related to the safety evaluation of food additives (OJ No L 320, 27.11.1980, p. 36).

Studies in animals can be substituted by validated in vitro tests provided that the test results are of comparable quality and usefulness for the purpose of safety evaluation.

this heading must cover the manufacturing process, information on the starting and raw materials, specific measures on TSEs and adventitious agents safety evaluation and facilities and equipment.

The Contracting Parties shall ensure the high quality, validity and reliability of safety evaluation data obtained during non-clinical testing on all chemicals as identified in Annex I before they are placed on the market.