The General Directorate of Protection and Control, of the Ministry of Agriculture and Rural Affairs shall be the competent authority in Turkey for verifying and certifying that live bivalve molluscs, echinoderms, tunicates and marine gastropods fulfil the requirements of Directive 91/492/EEC.

Commission Decision 98/740/EC of 14 December 1998 amending Decision 96/333/EC establishing health certification of live bivalve molluscs, echinoderms, tunicates and marine gastropods from third countries which are not covered by a specific decision(6), is to be incorporated into the Agreement.

Commission Decision 96/333/EC of 3 May 1996 establishing health certification of live bivalve molluscs, echinoderms, tunicates and marine gastropods from third countries which are not yet covered by a specific decision(3), as amended by Decision 98/740/EC(4), is applicable until 31 December 2000.

The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax’ s benefits are greater than its risks for the treatment of newborns at or more than 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.

The reductions in LV mass observed by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment were associated with meaningful symptom improvement as measured using the NYHA and CCS in Fabry patients with severe heart failure or anginal symptoms at baseline.

Following a restructuring of the Tunisian administration, the competent authority for verifying and certifying compliance of fishery and aquaculture products and bivalve molluscs, echinoderms, tunicates and marine gastropods has changed to the "direction générale des services vétérinaires (DGSV)".

The Socialist Republic of Vietnam wishes to export to the Community frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods which have been sterilised or heat-treated in accordance with the requirements of Commission Decision 93/25/EEC(5), as amended by Decision 97/275/EC(6).

whereas the same legislation empowers the Ministry of Fisheries to authorize or prohibit the harvesting of bivalve molluscs, echinoderms, tunicates and marine gastropods from certain zones on the basis of a report from the animal Husbandry Directorate and the Scientific Institute for Maritime Fisheries;

Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution. • Patients should be monitored during treatment for possible clinical complications due to hypotension or hypovolaemia.

Commission Decision 98/571/EC of 12 October 1998 amending Decision 97/20/EC establishing the list of third countries fulfilling the equivalence conditions for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods(2), is to be incorporated into the Agreement.

The wording of Decisions 98/569/EC and 98/570/EC should be aligned on the wording of more recently adopted Commission decisions, laying down special conditions governing imports of bivalve molluscs, echinoderms, tunicates, marine gastropods, fishery and aquaculture products originating in certain third countries.

The Ministry of Agriculture and Cooperatives, Department of Fisheries - Fish Inspection and Quality Control Division - (FIQCD) shall be the competent authority in Thailand for verifying and certifying that bivalve molluscs, echinoderms, tunicates and marine gastropods fulfil the requirements of Directive 91/492/EEC.

Whereas the provisions of legislation of Tunisia makes the 'Direction Générale de la Sante Animale (DGSA) du Ministere de l'Agriculture` responsible for inspecting the health of live bivalve molluscs, echinoderms, tunicates and marine gastropods and for monitoring the hygiene and sanitary conditions of production;

The National Fisheries Inspection and Quality Assurance Centre (Nafiqacen) of the Ministry of Fisheries shall be the competent authority in the Socialist Republic of Vietnam for verifying and certifying that bivalve molluscs, echinoderms, tunicates and marine gastropods fulfil the requirements of Directive 91/492/EEC.

The provisions of legislation of the Socialist Republic of Vietnam make the National Fisheries Inspection and Quality Assurance Centre (Nafiqacen) responsible for inspecting the health of bivalve molluscs, echinoderms, tunicates and marine gastropods and for monitoring the hygiene and sanitary conditions of production.

Whereas legislation of Australia makes the 'Department of Primary Industries and Energy - Australian Quarantine and Inspection Service - (AQIS)` responsible for inspecting the health of live bivalve molluscs, echinoderms, tunicates and marine gastropods and for monitoring the hygiene and sanitary conditions of production;

Commission Decision 97/20/EC of 17 December 1996 establishing the list of third countries fulfilling the equivalence conditions for the production and placing on the market of bivalve molluscs, echmoderms, tunicates and marine gastropods (OJ L 6, 10.1.1997, p. 46), as corrected by OJ L 239, 30.8.1997, p. 60, as amended by:

Commission Decision 2002/225/EC of 15 March 2002 laying down detailed rules for the implementation of Council Directive 91/492/EEC as regards the maximum levels and the methods of analysis of certain marine biotoxins in bivalve molluscs, echinoderms, tunicates and marine gastropods(2) is to be incorporated into the Agreement.

in addition, where the fishery products are frozen or processed bivalve molluscs: the molluscs were obtained from approved production areas laid down by Annex B to Decision 93/387/EEC of 7 June 1993 laying down special conditions for the import of live bivalve molluscs echinoderms, tunicates, and marine gastropods originating in Morocco.

Commission Decision of 18 October 2002 amending Decision 98/569/EC laying down special conditions governing imports of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Tunisia, and Decision 98/570/EC laying down special conditions governing imports of fishery and aquaculture products originating in Tunisia

The 'Ministry of Agriculture, Forestry and Fisheries - National Fisheries Administration - National Fishery Products Inspection Station (NFPIS)` shall be the competent authority in the Republic of Korea for verifying and certifying that live bivalve molluscs, echinoderms, tunicates and marine gastropods fulfil the requirements of Directive 91/492/EEC.

INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of newborns ≥ 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.

in addition, where the fishery products are frozen or processed bivalve molluscs: the molluscs were obtained from approved production areas laid down by the Annex to Decision 95/453/EC of 23 October 1995 laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Republic of Korea.

Since the health certification of the above products will fall under the scope of the present Decision, Commission Decision 94/778/EC of 30 November 1994 laying down special conditions for the import of frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Turkey(8), as last amended by Decision 1999/767/EC, shall be repealed.

Whereas legislation of the Republic of Korea makes the 'Ministry of Agriculture, Forestry and Fisheries - National Fisheries Administration - National Fishery Products Inspection Station (NFPIS)` responsible for inspecting the health of live bivalve molluscs, echinoderms, tunicates and marine gastropods and for monitoring the hygiene and sanitary conditions of production;

Whereas the veterinary checks on imported bivalve molluscs, echinoderms, tunicates and marine gastropods have to be carried out in accordance with Council Directive 90/675/EEC of 10 December 1990, laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (2), as last amended by Directive 95/52/EC (3);

Whereas Moroccan legislation makes veterinary inspectors, assisted by technical assistants from the Direction de l'élevage (Animal Husbandry Directorate) of the Ministry for Agriculture and Agrarian Reform, responsible for inspecting the health of live bivalve molluscs, echinoderms, tunicates and marine gastropods and monitoring the hygiene and sanitary conditions of production;

It has been scientifically proven that certain marine biotoxins such as those of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid (OA) and dinophysistoxins (DTXs)) and also yessotoxins (YTXs), pectenotoxins (PTXs) and azaspiracids (AZAs), pose a serious hazard to human health when present above certain limits in bivalve molluscs, echinoderms, tunicates or marine gastropods.

Furthermore, Peru wishes to export to the Community only frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods which have been sterilised or heat-treated in accordance with the requirements of Commission Decision 2003/774/EC of 30 October 2003 approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods(6).

'7. in addition, where the fishery products are frozen or processed bivalve molluscs: the molluscs were obtained from approved production areas listed in the Annex to Commission Decision 97/562/EC (*) laying down special conditions for the import of bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Thailand and which have been sterilized or heat-treated in accordance with the requirements of Commission Decision 93/25/EEC (**).

Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.

"7. in addition, where the fishery products are frozen or processed bivalve molluscs: the molluscs were obtained from approved production areas laid down by the Annex to Commission Decision 2000/333/EC(7) laying down special conditions for the import of bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Socialist Republic of Vietnam and which have been sterilised or heat-trated according to the requirements of Commission Decision 93/25/EC."

Recent myocardial infarction The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) was a randomised, controlled, multinational, double-blind study in 14,703 patients with acute myocardial infarction and signs, symptoms or radiological evidence of congestive heart failure and/ or evidence of left ventricular systolic dysfunction (manifested as an ejection fraction ≤ 40 % by radionuclide ventriculography or ≤ 35 % by echocardiography or ventricular contrast angiography).

The Committee for Medicinal products for Human Use (CHMP) decided that SonoVue’ s benefits are greater than its risks to enhance the echogenicity (ultrasound contrast) of the blood in echocardiography in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation, and in Doppler of macrovasculature (cerebral arteries, extracranial carotid or peripheral arteries and portal vein) or microvasculature (liver and breast lesions).

Article 1 of Commission Decision 95/453/EC of 23 October 1995 laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Republic of Korea(3), as last amended by Decision 1999/530/EC(4), states that the Ministry of Maritime Affairs and Fisheries - National Fishery Products Inspection Station (NFPIS) shall be the competent authority in the Republic of Korea for verifying and certifying compliance of fishery and aquaculture products with the requirements of Directive 91/492/EEC.

Consignments of live bivalve molluscs, echinoderms, tunicates and marine gastropods brought into the territories defined in Annex I of Directive 90/675/EEC for direct human consumption shall have been harvested from approved production areas approved and inspected by the competent authority of the third country, shall come from an establishment inspected and approved by the competent authority of the third country, and shall be accompanied by…the original of a numbered health certificate attesting that the health conditions of production, handling, where necessary purification, packaging and identification of the products are at least equivalent to those set out in Directive 91/492/EEC.

In addition, where the fishery products are frozen or processed bivalve molluscs the raw material shall be obtained from approved production areas as laid down by the Annex B to Commission Decision 94/777/EC of 30 November 1994 laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Turkey(4), as last amended by Decision 1999/767/EC(5), and they shall be sterilised or heat treated according to the requirements of Decision 93/25/EEC of 11 December 1992 approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods(6), as last amended by Decision 97/275/EC(7).

Whereas butafosfan, eucalyptus globulus, furosemide, echinacea, cupressi aetheroleum, crataegus, cefalonium, carlinae radix, cardiospermum halicacabum, turnera diffusa, calendula officinalis, euphrasia officinalis, boldo folium, bellis perennis, artemisia abrotanum, arnicae radix, arnica montana (arnicae flos, arnicae planta tota), aloes, Barbados, Capae, their standardised dry extract, preparations thereof, allium cepa, ailanthus altissima, agnus Castus, aesculus hippocastanum, camphora, lobaria pulmonaria, syzygium cumini, solidago virgaurea, silybum marianum, serenoa repens, prunus laucerasus, okoubaka aubrevillei, viscum album, symphyti radix, lidocaine, hamamelis virginiana, lachnanthes tinctoria, hypericum perforatum and ginkgo biloba and harpagophytum procumbens and lavandula atheroleum and ginseng should be inserted into Annex II to Regulation (EEC) No 2377/90;

Echo-sounding instruments and asdic apparatus