Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 3100 vaccinees during six months of follow-up.

By Commission Decision 1999/217/EC certain flavouring substances received first priority in the evaluation programme since concerns about the safety of the health of consumers were expressed by some Member States.

identification of appropriate techniques to improve reactor safety through research and development and evaluation studies on nuclear reactors in operation as well as on new types of nuclear reactors and fuel cycles.

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.

Not later than 14 December 2008 the Commission shall submit an evaluation report to the European Parliament and the Council, based on a detailed analysis and evaluation of the provisions of the IMO Convention, the implementation thereof and new insights gained with regard to the correlation between safety and the level of training of ships' crews.

Since an evaluation of the post-marketing safety database for Caelyx in patients has not suggested a significant nephrotoxicity liability of Caelyx, these findings in monkeys may not have relevance to patient risk assessment.

The Scientific Committee on Food concluded that because of the wide physical and chemical differences in smoke flavourings used for flavouring food, it is not possible to design a common approach to their safety assessment and, accordingly, toxicological evaluation should focus on the safety of individual smoke condensates.

the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorization safety studies.

While the evaluation of those substances is being completed by the European Food Safety Authority their use should continue to be permitted in the manufacture of products marketed before the entry into force of this Directive.

There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.

The MAH should submit one yearly PSURs.Therefore, based upon the safety profile of AVANDAMET, which requires a continuous evaluation, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.

There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.

Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.

The Applicant/ MAH considers that the extent of the total safety database is entirely consistent with the recommendations of the CHMP Guideline on Clinical Evaluation of New Vaccines and is sufficiently large to identify uncommon events.

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;

Those chemical substances that have since been evaluated by the Scientific Committee on Food or by the European Food Safety Authority and have received a favourable scientific evaluation should be included in the Annex to Directive 2001/15/EC.

New and improved tools: research will focus on models for performance, and safety assessment, and methodologies to demonstrate long term safety, including sensitivity and uncertainty analyses, and development and evaluation of alternative measures of performance and of better governance processes that properly address public concerns on waste disposal.

Guidelines on the quality, safety and efficacy of medicinal products for human use. All information which is relevant to the evaluation of the medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product.

It is appropriate to provide for a simplified and rapid notification procedure to enable the introduction of certain minor changes, which do not affect the approved quality, safety or efficacy of the product, without prior evaluation by the reference Member State.

These safety updates shall consist of a line listing of individual case reports accompanied by an overall scientific evaluation including a narrative review of the nature and other relevant characteristics of reactions, with special attention to any change in frequency.

Whereas a further toxicological evaluation of strontium chloride, based on new data submitted by industry, shows that the use of this substance may be extended, without any safety risk, to shampoos and face care products provided a maximum concentration is not exceeded;

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.

However, the CHMP considered that there were concerns regarding the long-term antibody persistence, the adequacy of the safety data set in the light of the CHMP Guideline on Clinical Evaluation of New Vaccines, and the indication of Menitorix for both priming and boosting.

A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.

A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (in the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.

The indications giving safety advice (S phrases) shall comply with the wording in Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II and III to this Directive.

Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients(3) does not apply to additives and flavourings intended to be used in foodstuffs as, for the purpose of testing these substances for their safety evaluation, they come under other Community provisions, namely Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(4), as amended by Directive 94/34/EEC of the European Parliament and of the Council(5), and Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(6), as amended by Commission Directive 91/71/EEC(7);

Whereas a further toxicological evaluation, based on new data submitted by industry, of benzethonium chloride, shows that an acceptable safety margin is obtained as long as its use is limited to preservatives, at a limited concentration and for a reduced time of contact with the skin;

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.

the evaluation of the safety for human health of the ingredient as used in the finished product(s), taking into account the ingredient's toxicological profile, chemical structure and the level of exposure, as specified in Article 7a (1) (d) and (e) and Article 7a (2) of Directive 76/768/EEC;

Evaluation of the application for marketing authorization shall be based on clinical trials including clinical pharmacological trials designed to determine the efficacy and safety of the product under normal conditions of use, having regard to the therapeutic indications for use in human beings.

In its Resolution of 5 October 2000 on the sinking of the Greek ferry "Samina"(5), the European Parliament expressly stated that it awaited the evaluation by the Commission of the effectiveness of the Stockholm Agreement and other measures for improving the stability and safety of passenger ships.

a statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemised in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.

The Marketing Authorisation Holder commits to generate a collection of long-term data for the evaluation of long-term safety of risperidone in children and adolescents with conduct disorder in terms of potential effects on growth (height and weight), mental development, and sexual maturation (by Tanner stage).

In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Community standard, leading to a single decision on the area of disagreement binding on the Member States concerned.

The fields of competence of the Scientific Committees shall be as set out in Annex I, without prejudice to the competence conferred by Community legislation to other Community bodies undertaking risk assessment, such as the European Food Safety Authority and the European Agency for the Evaluation of Medicinal Products.

Whereas the examination of variations to the terms of existing authorizations not requiring full evaluation of the product's quality, safety and efficacy should be charged according to the complexity of the variations and the real workload linked to them, and therefore at a rate far lower than for a standard application;

By way of exception to these general principles, the drawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities.

Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.

Evaluation of the potential of innovative concepts and development of improved and safer processes for the generation and exploitation of nuclear energy that have been identified as offering longer term benefits in terms of safety, environmental impact, resource utilisation, proliferation resistance or diversity of application.

Unless otherwise specified, the following safety profile of Yondelis is based on the evaluation in clinical trials of 569 patients treated up to April 2007 with the recommended treatment regime in several cancer types including soft tissue sarcoma, breast cancer, osteosarcoma, ovarian cancer, GIST, melanoma and renal carcinoma.

Within five years from the date of the Agency having taken up its responsibilities, the Administrative Board should commission an independent external evaluation in order to assess the impact of this Regulation, the Agency and its working practices on establishing a high level of maritime safety and prevention of pollution by ships,

Whereas, by way of exception to the general principles, the drawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities;

Whereas Council Directive 93/39/EEC of 14 June 1993 amending Directive 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (9) has provided that in the event of a disagreement between Member States about the quality, safety or efficacy of a medicinal product which is the subject of the decentralized Community authorization procedure, the matter should be resolved by a binding Community decision following a scientific evaluation of the issues involved within a European medicinal product evaluation agency;

On the basis of the evaluation described in paragraph 1, the Commission, after first consulting the Advisory Committee on Safety, Hygiene and Health protection at Work, shall propose European objectives in the form of indicative occupational exposure limit values for the protection of workers from chemical risks, to be set at Community level.

CHAPTER 2 MEDICINES FOR HUMAN AND VETERINARY USE Orphan medicinal products for human use Scientific advice to enterprises Initial evaluation Establishment of maximum residue limits for veterinary medicines Post-authorisation activities Parallel distribution Safety of medicines Arbitrations and referrals Herbal medicinal products for human use

Whereas a comprehensive evaluation of Directive 70/311/EEC has shown that it is possible to improve road safety further by applying practical experience and technological development and taking into account the progress made in the Economic Commission for Europe of the United Nations, notably in Regulation No 79 and supplements 1 and 2 thereto.

As a Condition of the Marketing Authorisation, the CHMP requested the MAH to commit to generate a collection of long-term data for the evaluation of long-term safety of risperidone in children and adolescents with conduct disorder in terms of potential effects on growth (height and weight), mental development, and sexual maturation (by Tanner stage).

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.

Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority (Authority), of any risks which they present for human and animal health and, as the case may be, for the environment.