Analysis of long-term data from study 006 (median follow-up 180 weeks, 102 weeks, and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.

Analysis of long-term data from a clinical study (median follow-up 180 weeks, 102 weeks and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.

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;

Continue the fight against drugs by (i) continuing to implement the national strategy to combat drug abuse and illicit traffic of drugs and precursors, (ii) strengthening the administrative and coordinating capacities of the National Anti-drug Agency, (iii) legally establishing a national focal point with a clear mandate that stipulates its main tasks and responsibilities and (iv) further developing the drug information system to provide more accurate monitoring and assessment of the situation.

The requested additional analyses of the EPC trial data confirm an increased risk for deaths coded as heart failures (however, with no overall excess risk in the cardiovascular system), an increased risk of urogenital symptoms (including gynaecomastia and breast pain) mainly during the first year of intake, and further indicate the absence of an adverse effect on thromboembolic events during the follow-up (supported by a pattern of events inconsistent with hormonal effects).

The Commission has, on this basis, developed a combined monitoring-based and modelling-based priority setting (COMMPS) scheme, in collaboration with experts of interested parties, involving the Scientific Committee for Toxicity, Ecotoxicity and the Environment, Member States, EFTA countries, the European Environment Agency, European business associations including those representing small and medium-sized enterprises and European environmental organisations.

Whereas under the terms of Council Decision 95/528/EC of 5 December 1995 amending Regulation (EEC) No 2847/93 and Decision 89/631/EEC as regards the time limit for implementing certain pilot projects on continuous position monitoring of Community fishing vessels and the Community contribution to the expenditure incurred in their implementation (3), the date of the completion of the pilot projects undertaken by the Member States, as well as that of the final Council decision concerning the application of the system of continuous location of the Community fishing vessels, set out in Regulation (EEC) No 2847/93, were deferred by six months;

ANNEX PROVISIONS SPECIFYING HOW DATA IN CONNECTION WITH THE SATELLITE-BASED POSITION MONITORING OF COMMUNITY FISHING VESSELS OPERATING UNDER THE AGREEMENT BETWEEN THE EUROPEAN ECONOMIC COMMUNITY AND THE GOVERNMENT OF THE DEMOCRATIC REPUBLIC OF MADAGASCAR ON FISHING OFF MADAGASCAR IS TO BE TRANSMITTED In view of the fact that the Republic of Madagascar has implemented a vessel monitoring system (VMS) applicable to its national fleet and intends to extend this system on a non-discriminatory basis to all vessels operating in its fishing zone, and that Community vessels have been subject to satellite monitoring wherever they operate since 1 January 2000 under Community legislation, it is recommended that the national authorities of the flag States and of the Republic of Madagascar should monitor by satellite as follows vessels operating under the Agreement between the European Economic Community and the Democratic Republic of Madagascar on fishing off Madagascar (hereinafter referred to as the "Agreement"):

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 monitoring system to be set up.

improved notification and statistical systems for epidemiological monitoring;

measures to require the use of a vessel monitoring system as agreed by the Commission.

obtained, within the context of monitoring programmes, by reference to officially recognised quality assurance schemes or by means of an epidemiológica! surveillance system where this is authorised under veterinary legislation.

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.

Have agreed in the common interest of the Parties to set up with the financial assistance of the Community under the relevant provisions of Title VIII of the Agreement a system to monitor the quality and the quantity of water in their cross-boundary rivers with a view to: