Pain assessment is a very important part of the role of the nurse when caring for the patient in pain.

(3) The committee may request only such supplementation of applications as will eliminate minor discrepancies with the requirements of the tender documentation and which shall in no way affect the substance of the application and assessment and ranking of the individual application in accordance with the established criteria for selection of the public-private partnership contractor.

all applications for EC examination received,

Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 31 to 43 apply.

The manufacturer must lodge an application for examination of the design with a single notified body.

The application for EC type-examination must be lodged by the manufacturer or by his authorised representative established within the Community with a notified body of his choice.

Proposals shall be evaluated, on the basis of pre-announced selection and award criteria, by an evaluation committee set up for that purpose, with a view to determining which proposals may be financed.

2 the duties, responsibilities and training requirements of all port facility personnel with a security role and the performance measures needed to allow their individual effectiveness to be assessed;.

During the process of evaluating applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms, necessary consultations shall be held by the rapporteur with the bodies set up by the Community or the Member States in accordance with Directive 2001/18/EC.

the assignment of roles and tasks to the Community and to the Member States throughout the subsequent development and validation and implementation phases;

If the adjudicating entity can demonstrate that tests or verifications for previous applications remain valid in the new application, then the notified body shall take them into account in the conformity assessment.

Until publication, applicants shall follow the "Guidance on submissions for food additive evaluations" by the Scientific Committee on Food, of 11 July 2001 or its latest update:

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or EN ISO14001, when assessing applications and monitoring compliance with the criteria (Note:

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria (note:

The presentation and content of the marketing authorisation application dossier have to be improved in order to facilitate the assessment and the better use of certain parts of the dossier which are common to several medicinal products.

The Competent Bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex (Note:

The Competent Bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria (note:

The Competent Bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex.

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14 001, when assessing applications and monitoring compliance with the criteria in this Annex (Note:

At an early stage in the evaluation process of applications for financial contributions, the Commission shall inform the applicants if they are not eligible or if their application does not provide the information that is necessary to verify the application's conformity with the selection criteria.

Before lodging an application for a conformity assessment pursuant to Article 11(1) of Directive 93/42/EEC, the manufacturer of medical devices referred to in Article 1(1), shall carry out the risk analysis and the risk management scheme set out in the Annex to this Directive.

When acting in relation to setting or reviewing the ecological criteria as well as the related assessment and compliance verification requirements for a product group, the EUEB shall select one or more of the competent bodies referred to in Article 14 of Regulation (EC) No 1980/2000 who are willing to take a lead role.

During the process of evaluating applications for marketing authorizations for products containing or consisting of genetically modified organisms, necessary consultations will be held by the rapporteur with the bodies set up the Community or the Member States in accordance with Directive 90/220/EEC.

During the process of evaluating applications for marketing authorizations for veterinary medicinal products containing or consisting of genetically modified organisms, necessary consultations shall be held by the rapporteur with the bodies set up by the Community or the Member States in accordance with Directive 90/220/EEC.

whereas at the request of the European Agency for the Evaluation of Medicinal Products, all Community marketing authorisation holders, or applicants with a positive opinion from the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products, have confirmed that the products concerned do not contain bovine tissue of United Kingdom origin;

To be taken into account during the assessment of an application, clinical trials, conducted outside the European Community, which relate to medicinal products intended to be used in the European Community, shall be designed, implemented and reported on what good clinical practice and ethical principles are concerned, on the basis of principles, which are equivalent to the provisions of Directive 2001/20/EC.

That intermediary shall be entrusted with evaluating the application and, in the event of a favourable opinion, passing it on to the Commission.

How far into the evaluation was the application when it was withdrawn?

The CHMP normally takes up to 210 days to evaluate a new application.

verifying that the application conforms with the assessment and verification requirements;

It shall not be the function of the Committee to appraise the merits of decisions taken in individual cases by the authorities referred to in Article 49.

The manufacturer shall lodge an application for assessment of his quality system for the equipment and protective systems, with a notified body of his choice.

Assessment and verification: a sample of the product packaging shall be provided on application, together with a corresponding declaration of compliance with this criterion.

Assessment and verification: The applicant shall declare the compliance of the product with these requirements, and shall provide a copy of the packaging to the competent body assessing the application.

The nature of the product plays a role in particular for final products in assessing both the likely negative and the likely positive effects.

However the possible application by a Member State of the standard average provided for in Annexes A, B and C shall not be considered an indirect refund in the assessment of individual cases.

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria

The Competent Bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria.

The company also presented data on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment.

Assessment and verification: the applicant shall declare the compliance of the product with these requirements, and shall provide a copy of the instruction manual to the competent body assessing the application.

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex.

Within the framework of this Agreement, the Australian Regulatory Authority will within five (5) working days register a product from the European Community upon receipt of an application accompanied by the designated fee without further assessment of the product.

The Competent Bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO14001, when assessing applications and monitoring compliance with the criteria(note:

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria (Note:

Assessment and verification: The applicant shall declare the compliance of the product with this requirement, and shall provide a copy of the eco-label as it appears on the packaging and/or product to the competent body assessing the application.

The company did apply for an authorisation to use INCRELEX in these children, but withdrew its application after the end of the medicine’ s assessment, as this disease is not listed in the medicine ’ s ‘ orphan’ designation.

Within the framework of this Agreement, the Australian State and Territory Regulatory Authorities will within five (5) working days register a product from the European Community upon receipt of an application accompanied by the designated fee without further assessment of the product.

2 the duties, responsibilities and training requirements of all port facility personnel with a security role and the performance measures needed to allow their individual effectiveness to be assessed;.

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or EN ISO14001, when assessing applications and monitoring compliance with the criteria (Note, it is not required to implement such management schemes).