In case of urgency, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day.

As it is not compulsory to specify the recommended antibiotic strategy in the wording of the therapeutic indication in the Marketing Authorisation, the CHMP recommended that the proposed 4.1 SPC wording “ prophylaxis of invasive infections due to Neisseria meningitidis” remain, and accepted the adult posology:

During the interim period specified in paragraph 3, commercial production shall not be undertaken pursuant to an approved plan of work until the operator has applied for and has been issued a production authorisation by the Authority.

The Agency will advance the work on the new database for GMP certificates and manufacturing authorisations, and will complete the construction of an EU telematics data centre with high availability, high scalability and good performance.

Between July and September 2005, the marketing authorisation holder gave oral explanations to the CHMP and its working parties on the low immunogenicity of the HepB component in long-term protection against Hepatitis B afforded by Hexavac.

For the purpose of this paragraph "involved in actual relevant aircraft or component maintenance" means that the person has worked in an aircraft or component maintenance environment and has either exercised the privileges of the certification authorisation and/or has actually carried out maintenance on at least some of the aircraft type systems specified in the particular certification authorisation.

Whereas the review programme on active substances will need to take account of other work programmes within the framework of other Community legislation concerned with the review or authorisation of substances and products or relevant international Conventions;

The Member State shall examine this file and, taking account of the implementation strategy indicated in the applicable TSI, shall decide whether the size of the works means that a new authorisation for placing in service within the meaning of this Directive is needed.

Where urgent action to protect public health is necessary, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided that the Agency, the Commission and the other Member States are informed no later than the following working day.

The Marketing Authorisation Holder commits to timely submission of MR/national variations to implement labelling changes, which may be agreed following Pharmacovigilance Working Party (PhVWP) recommendation concerning suicidal ideation and behaviour with anti-epileptic drugs.

The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of biocidal products intended to protect the health of the distributors, users and workers concerned.

Whereas the maintenance of the authorisations for monensin sodium, salinomycin sodium, flavophospholipol and avilamycin will have to be reviewed in the light of the results of the work on antimicrobial resistance carried out by the working group set up by the Scientific Steering Committee;

In view of the growing importance of post-authorisation surveillance activities in the work of the Agency and in order to improve the capacity of the Community to identify and manage risks arising from the use of, in particular, innovative medicines, the annual fee should be adjusted by 16 %.

If urgent action is necessary for protecting human or animal health, the Member State concerned may suspend the marketing authorisation of a veterinary medicinal product, provided that the Agency, the Commission and the other Member States are informed on the following working day at the latest.";

Within the framework of this Agreement, the ACA will use its best endeavours, within five (5) working days and in any case no longer than 10 days, to issue such an authorisation in accordance with procedures set out in the Telecommunications Labelling (Customer Equipment and Customer Cabling) Notice No 2 of 1997.

Such production authorisations may not be applied for or issued more than five years prior to the planned commencement of commercial production under the plan of work unless, having regard to the nature and timing of project development, the rules, regulations and procedures of the Authority prescribe another period.

Based on evaluation of the currently available data and the scientific discussion within the Committee and at the CHMP’ s Blood Products Working Party, the CHMP concluded that the benefits of Uman Big outweigh its risks, and that therefore the marketing authorisation for Uman Big should be granted in all concerned member states.

In case of intra-Community trade, the transit shall be subject to the authorisation of the competent authorities of the Member State of transit and the Member State of destination, and the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

Given the fact that several EU member states have rejected the MR tablet Marketing Authorisations due to a negative benefit/ risk, and taking into consideration that only 5 countries approved this pharmaceutical formulation, no consensual recommendation on the SPC wording could be provided at a European level on the basis of this present Article 30 Referral procedure.

"renewal" means any major substitution work on a subsystem or part subsystem which requires fresh authorisation for putting into service within the meaning of Article 14(1); (n) "existing rail system" means the structure composed of lines and fixed installations of the existing rail system plus the rolling stock of all categories and origin travelling on that infrastructure.

In addition to their task of providing objective scientific opinions to the Community and Member States on the questions which are referred to them, the members of each committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation.

The CHMP noted the pivotal study JHQJ was powered to detect differences in TtDP in overall survival and that the pivotal study for the ovarian cancer had a specific population consisting of platinum sensitive patients with a very poor prognosis and the CHMP was of the opinion that the proposed wording was in accordance with the submitted study for the marketing authorisation in this indication.

Implement and strengthen the European risk-management strategy in close cooperation with the Member States; Fully apply tools provided by the new legislation, including risk-management plans and specialised studies on safety profiles of medicinal products post authorisation; Work to establish a network for intensive monitoring of targeted medicines; Full integration of the pharmacovigilance network between EU regulatory bodies.

the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD template, the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxastad 4 mg prolonged release tablets and associated names (see Annex I).

The Marketing Authorisation Holder considers that the guidelines were written primarily for new molecules where the risk to the environment has not been characterized and that it is not the case for ivermectin-containing veterinary medicinal products that have been in extensive worldwide use for nearly 25 years and that real risk or detrimental environmental effect attributable to ivermectin-based veterinary medicinal products would have been observed.

In case of a pandemic situation with respect to the human influenza virus, duly recognised by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council(8), competent authorities may exceptionally and temporarily consider the variation to the terms of the marketing authorisation for human influenza vaccines to be accepted after an application has been received and before the end of the procedure laid down in Article 7.

Furthermore, in order to create greater legal certainty it is necessary to define the responsibilities regarding the transparency rules for the Agency's work, to set certain conditions for the marketing of medicinal products authorised by the Community, to confer on the Agency powers to monitor the distribution of medicinal products authorised by the Community and to specify the sanctions and the procedures for implementing them in the event of failure to observe the provisions of this Regulation and the conditions contained in the authorisations granted under the procedures it establishes.

"self-employed driver" shall mean anyone whose main occupation is to transport passengers or goods by road for hire or reward within the meaning of Community legislation under cover of a Community licence or any other professional authorisation to carry out the aforementioned transport, who is entitled to work for himself and who is not tied to an employer by an employment contract or by any other type of working hierarchical relationship, who is free to organise the relevant working activities, whose income depends directly on the profits made and who has the freedom to, individually or through a cooperation between self-employed drivers, have commercial relations with several customers.

With regard to the Office for Official Publications, each institution shall retain the powers of authorisation for expenditure charged to the appropriations for the publication of all work entrusted to outside bodies by the Office.