In the case of persons having access to EU TOP SECRET information at meetings, etc., the competent Control Officer of the service or body in which that person is employed shall notify the body organising the meeting that the persons concerned have such authorisation.

The competent authority may require the applicant or the marketing authorisation holder to provide sufficient quantities of the substances to enable controls to be made on the identification of the presence of residues of the veterinary medicinal products in question.

requiring, under the authorisation and control of the coastal State, the conduct of specified fisheries research programmes and regulating the conduct of such research, including the sampling of catches, disposition of samples and reporting of associated scientific data;

It is necessary to provide for uniform models for transport documents such as the control document for liberalised occasional services and also the authorisation and the application form for non-liberalised services in order to facilitate and simplify inspection procedures.

If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take all the necessary measures vis-a-vis the marketing authorisation holder and the manufacturer, where appropriate, and shall inform accordingly the other Member States in which the veterinary medicinal product is authorised.";

In the case of persons having access to TRES SECRET UE/EU TOP SECRET information at meetings, etc., the competent Control Officer of the service or body in which that person is employed shall notify the body organising the meeting that the persons concerned have such authorisation.

Where authorisation as referred to in paragraph 7 is applied for, the national judicial authority shall control that the Commission decision is authentic and that the coercive measures envisaged are neither arbitrary nor excessive having regard to the subject matter of the inspection.

In order to ensure the correct functioning of the principles of mutual recognition of the authorisation and of the home country control, Member States permitting such delegations should ensure that the management company to which they granted an authorisation does not delegate globally its functions to one or more third parties, so as to become a letter box entity, and the existence of mandates does not hinder an effective supervision over the management company.

Transboundary shipment of waste within, into or out of the European Union, requiring an authorisation or prohibited in the meaning of Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community(18).

Likewise, in view of possible health hazards, the period of this derogation should be limited and the areas for the marketing of washed eggs restricted to those parts of the Community's territory in which the competent authorities responsible for issuing authorisations carry out their controls.

The term "good manufacturing practice (GMP)" means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications.

Although the Marketing Authorisation Holder has not conducted specific studies with lamotrigine monotherapy solely in patients with primary generalised tonic clonic seizures, data from controlled initial monotherapy studies (studies UK49/ 89, UK74) reassure on the efficacy of lamotrigine on this seizure types.

This Directive aims to achieve the objectives set forth above without prejudice to Community or national law governing freedom to provide services or, where applicable, host Member State control and/or authorisation or supervision systems in the Member States where this is compatible with Community legislation.

On 7 December 2006, Fournier Laboratories Ireland Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Synordia, for the improvement of glycaemic control and dyslipidaemia in patients with type 2 diabetes.

'Product- or process-oriented` inspections (which may be 'pre-marketing` inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation.

Article 17 is without prejudice to Member States' rights to maintain or introduce, to the extent permitted under the Treaty, charges, taxes, levies or fees with regard to authorisation, placing on the market, use and control of active substances and plant-protection products other than the fee provided for in Article 17.

Articles 12 and 13 are without prejudice to Member States' rights to maintain or introduce, in accordance with the Treaty, charges, levies or fees with regard to the authorisation, placing on the market, use and control of active substances and plant protection products other than the fee provided for in Articles 12 and 13.

The competent authority or authorities may suspend or revoke the accreditation, designation, authorisation or licensing of a tissue establishment or of a tissue or cell preparation process if inspections or control measures demonstrate that such an establishment or process does not comply with the requirements of this Directive.

An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in Article 8 or Articles 10, 10a, 10b, 10c and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out.";

With regard to the controlled substances listed in Annex B to this Agreement, the competent authority of the exporting Contracting Party shall forward a copy of the export authorisation to the competent authority of the importing Contracting Party and the export shall be authorised only when the importing Contracting Party has given its consent.

The approach adopted consists in bringing about such harmonisation as is essential, necessary and sufficient to achieve the mutual recognition of authorisations and prudential control systems, thereby making it possible to grant a single authorisation valid throughout the Community and apply the principle of supervision by the home Member State.

In view of implementing Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003, the applicant shall, together with the information specified under sections 1, 2 and 3 of this Annex, also provide samples of the food and feed and their control samples of a type and amount to be specified by the CRL for the specific application for authorisation.

"operator" means any natural or legal, private or public person who operates or controls the occupational activity or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of such an activity has been delegated, including the holder of a permit or authorisation for such an activity or the person registering or notifying such an activity; 7.

In connection with the authorisation of primary processors in respect of long flax fibre and simultaneously in respect of short flax fibre, the Member States may allow short flax fibre to be cleaned under the conditions laid down in this paragraph and if it considers the control arrangements to be satisfactory, so that the fibre complies with the impurity and shive limits laid down in Article 2(3)(b) of Regulation (EC) No 1673/2000.

"(b) in the case of veterinary medicinal products coming from third countries, even if manufactured in the Community, each production batch imported has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances, and all the other tests or controls necessary to ensure the quality of veterinary medicinal products in accordance with the requirements of the marketing authorisation.";

2.During the period referred to in the second subparagraph, the board of the offeree company shall obtain the prior authorisation of the general meeting of shareholders given for this purpose before taking any action, other than seeking alternative bids, which may result in the frustration of the bid and in particular before issuing any shares which may result in a lasting impediment to the offeror's acquiring control of the offeree company.

A provisional authorisation of a new additive shall be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock products, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that the condition laid down in Article 3a(a) of Directive 70/524/EEC, i.e. effectiveness, has been met.

The national judicial authority shall control that the Commission decision is authentic and that the coercive measures envisaged are neither arbitrary nor excessive having regard in particular to the seriousness of the suspected infringement, to the importance of the evidence sought, to the involvement of the undertaking concerned and to the reasonable likelihood that business books and records relating to the subject matter of the inspection are kept in the premises for which the authorisation is requested.

However, point D.2 of that Annex provides that, until 31 August 2003 at the latest, in the case of a traditional practice governed by special provisions of the Member State of production, that Member State may permit on certain conditions, by means of express authorisations and subject to suitable controls, that a quality sparkling wine psr be obtained by adding to the basic product from which the wine is made one or more wine-sector products which do not originate in the specified region whose name the wine bears.

In the interest of the clarity of Community legislation, and to ensure further harmonisation of Community animal health requirements upon importation, Decision 2000/462/EC should therefore be repealed and replaced by the provisions of this Decision restricting the authorisation of imports to queen bees (Apis mellifera) and queen bumble bees (Bombus spp.) with a small number of attendants, or to small colonies of bumble bees (Bombus spp.) bred under environmentally controlled conditions within recognised establishments.

A provisional authorisation of new additives or uses of additives shall be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock product, if its presence in feedingstuffs can be controlled, and it is reasonabe to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs.

A provisional authorisation of new additives, or new uses of additives shall be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock product, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has favourable effect on the characteristics of those feedingstufffs or on livestock production when incorporated in such feedingstuffs.

A provisional authorisation of new additives or new uses of additives shall be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock products, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs.

In the case of medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member State or Member States that granted the authorisation provided for in Article 40(3) of Directive 2001/83/EC to the importer, unless appropriate agreements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community.

Whereas a provisional authorisation of new additives or uses of additives may be given for a period of five years, if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock product, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs;

In the case of veterinary medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member State or Member States that granted the authorisation provided for in Article 44(3) of Directive 2001/82/EC to the importer, unless appropriate agreements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community.

Whereas Article 9e(1) of Directive 70/524/EEC provides that a provisional authorisation of new additives or new uses of additives may be given, if at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock products, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs;

control of such vessels in the Convention Area by means of fishing authorisation;

control measures, including the authorisation of vessels to fish, the marking of vessels and fishing gear, the recording of fishing activities, and the near-to-real time reporting of vessel movements and activities by means such as satellite surveillance;

It is then necessary to clarify the relationship between validation, authorisation and payment operations and the controls to be carried out by the authorising officer when validating expenditure, with the endorsement "passed for payment", and when authorising payment by checking the validity of the release from all liability, for which the authorising officer now has sole responsibility.