coordination of the supervision, under practical conditions of use, of medicinal products which have been authorised within the Community and the provision of advice on the measures necessary to ensure the safe and effective use of these products, in particular by evaluation, coordination of the implementation of pharmacovigilance obligations and the monitoring of such implementation;

Whereas at the same time the Member States should be enabled to authorize the monitoring of levels of pesticide residues in cereals produced and consumed in their territory by a system of surveillance and related measures so as to provide safeguards equivalent to those resulting from the levels laid down;

Pending further coordination, the competent authorities shall require institutions to set up systems to monitor and control their underwriting exposures between the time of the initial commitment and working day one in the light of the nature of the risks incurred in the markets in question;

This Decision is not intended to harmonise national vehicle registration systems but to build on them in order to ensure the compilation of a minimum set of data required to allow the proper functioning of a Community scheme to monitor the average specific emissions of CO2 from new passenger cars.

The main objectives of the surveillance network system are to make the official classification of holdings, to maintain such classification by regular inspection, to collect epidemiological data and to carry out disease monitoring so as to ensure compliance with all the provisions of this Directive and other directives in respect of health restrictions.

As referred to in Decision No 1753/2000/EC of the European Parliament and of the Council of 22 June 2000 establishing a scheme to monitor the average specific emissions of CO2 from new passenger cars(6), the Commission has carried out a study to investigate the possibilities and implications of a harmonised procedure for measuring the specific CO2 emissions from vehicles of category N1.

the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned, - the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the design and of the products, including control of products which do not conform;

Member States shall establish a computerised database which shall contain, for each processor and each producer and producer group, information identifying their establishments or their holdings, the quotas or the quantities appearing on production quota statements allocated to them and any other information which may be useful for monitoring the quota system.

Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications(4) provided for the establishment of monitoring systems for certain zoonoses and controls on salmonella in certain poultry flocks.

Information that is to be used for CO2/cars monitoring purposes (or to be included in electronic databases for subsequent use in a CO2/cars monitoring scheme) must be extracted from the official "information package" accompanying the notification of the granting of type-approval as circulated by the national type-approval authorities in the Member States and as laid down in Directive 70/156/EEC.

Control measures additional to those laid down in Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy(6) and in Commission Regulation (EC) No 1489/97 of 29 July 1997 laying down detailed rules for the application of Council Regulation (EEC) No 2847/93 as regards satellite-based vessel monitoring systems(7) are required to ensure compliance with the measures laid down in this Regulation.

Regulation (EC) No 2791/1999 lays down certain specific control measures to monitor Community fishing activities in the North-east Atlantic Fisheries Commission (NEAFC) regulatory area and to supplement the control measures provided for in Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy(2), as last amended by Regulation (EC) No 2846/98(3).

In order to make it possible for Community fishing activities in the NEAFC Regulatory Area to be monitored and to supplement the control measures provided for in Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy(3), certain specific control measures should be laid down, in particular as regards participation in fishing activities, the marking of vessels and fishing gear and their documents, the recording and reporting of catches and the transhipment of fish;

it is therefore necessary to include in national law appropriate effective and systematic financial or equivalent administrative penalties - such as injunctions combined with administrative fines, reporting to supervisory authorities on a regular basis, on-the-spot checks, publications in the national official journal and in the press, suspension of the activities of the company (prohibition on the conclusion of new contracts for a certain period), designation of a special representative of the supervisory authorities responsible for monitoring that the business is run in line with insurance laws, withdrawal of the authorisation for this business line, sanctions to be imposed on directors and management staff - in the event that the insurance undertaking or its representative fails to fulfil its obligation to make an offer of compensation within a reasonable time-limit;

Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor. • Patients with clinically significant infection requiring the use of antibiotics, antifungals, or antivirals, or who have completed prior anti-infectious therapy within 14 days of starting treatment should be treated with caution unless the use of antibiotics and antivirals were for prophylaxis purposes. • Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution. • Monitoring of laboratory test results is recommended including standard haematological and blood chemistry tests. • Patients receiving the following medicinal products should be treated with caution (see section 4.5) -Beta-blockers or other anti-hypertensive agents. -H1 blocking agents and neuroleptics (anti-psychotics) with H1 receptor blocking properties. -Tricyclic anti-depressants that may have H1 and H2 receptor blocking properties. -Monoamine oxidase inhibitors and anti-malarial and anti-trypanosomal agents. -Neuromuscular blocking agents, narcotic analgesics, and various contrast media.

The aforementioned systems of monitoring of the safeguard tariff quotas and retrospective surveillance provide information as to the origin of only some of the imports entering the Community market, and do not provide information as to the prices of those imports.