compliance with the requirements laid down in Annex IV, part A, Section I, point 1.4 to the said Directive shall have been checked by graders who are trained, qualified and authorized for that purpose under a programme approved and controlled by the Animal and Plant Health Inspection Service, US Department of Agriculture;

For the purposes of this Decision, 'on-the-spot checks in the veterinary field` (hereinafter referred to as 'checks`) means auditing and inspection measures necessary to ensure that, without prejudice to the control of the application of existing veterinary legislation, the public and animal health and animal protection guarantees offered by third countries as regards production conditions and placement on the market may be regarded as at least equivalent to those applied in the Community.

Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that this Directive has not been complied with or there is doubt as to the health of the animals or the quality of the semen, ova and embryos referred to in Article 1, carry out any checks it deems appropriate.

in its entirety or on one or more representative samples, including the packaging and, where appropriate, the transport vehicles, the consignment or lot or their wood packing material comply with the requirements laid down in this Directive, as specified in Article 13(1)(i) (plant health checks), and whether Article 16(2) applies.

Point IV of the health certificate laid down in the Annex to the Decision 98/422/EC and accompanying the consignments of fishery products from or originating in Tanzania and caught in the Lake Victoria, must be completed by the following point: "- The official inspector hereby certifies that the fishery products specified above were produced under a system of monitoring checks as laid down in chapter V, point II.3.B of the Annex to the Directive 91/493/EEC, and the results of these checks are satisfactory."

The competent authority shall check that the 'own health` checks provided for in Article 6 of Council Directive 91/493/EEC (3), drawn up and implemented by the person responsible for the establishment authorized in accordance with Decision 94/356/EC, shall apply specifically to the heat treatment defined in the Annex to this Decision.

Whereas Article 4 of Directive 71/118/EEC (8) requires Member States to ensure that checks are conducted to detect residues of substances having a pharmacological action, their derivatives and other substances which may be transmitted to poultrymeat and which may make the consumption of fresh poultrymeat dangerous or harmful to human health;

The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. The methodology described by the World Health Organisation, referred to above, as applied by rapporteur member states, checked and evaluated by the Commission in the framework of the Standing Committee on Plant Health, is in agreement with the guidance given by the Scientific Committee of Plants(15).

the plants, plant products or other objects in the consignment or lot came from a third country for which in or under comprehensive international phytosanitary agreements based on the principle of reciprocal treatment between the Community and a third country, provision for a reduced frequency of identity and plant health checks is mentioned,

Member States shall ensure that checks are effected to detect any residues of substances having a pharmacological or hormonal action, and of antibiotics, pesticides, detergents and other substances which are harmful or which might alter the organoleptic characteristics of egg products or make their consumption dangerous or harmful to human health.

In accordance with the procedure referred to in Article 18(2), certain cases or circumstances may be specified in which 'identity checks' and 'plant health checks' may be carried out at the place of destination, such as a place of production, approved by the official body and customs authorities responsible for the area where that place of destination is located, instead of the aforesaid other places, provided that specific guarantees and documents as regards the transport of plants, plant products and other objects are complied with.

be so supervised that a record, file or computer record is kept of all porcine animals at the centre, giving details of the breed, date of birth and identification of each of the animals, and also a record, file or computer record of all checks for diseases and all vaccinations carried out, giving also information from the disease/health file of each animal;

'Identity checks' and 'plant health checks' must be made, without prejudice to (c) and (d) below, by the official body of point of entry in connection with the customs formalities required for placing under a customs procedure as referred to in Article 13(1) or Article 13(4), and either at the same place as these formalities, on the premises of the official body of point of entry or at any other place close by and designated or approved by the customs authorities and by the responsible official body, other than the place of destination as specified under (d).

If, in the territory of a third country, a disease referred to in Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (22), a zoonosis or other disease or any other phenomenon or circumstance liable to present a serious threat to animal or public health manifests itself or spreads, or if any other serious animal health or public health reason so warrants, in particular in the light of the findings of its veterinary experts or in the checks carried out in a border inspection post, the Commission shall, acting on its own initiative or at the request of a Member State, adopt one of the following measures without delay, depending on the gravity of the situation:

Whereas, however, with regard to certain epizootic diseases, different health situations still prevail in the Member States and whereas, pending a Community approach on the methods to combat these diseases, the question of checking intra-Community trade in livestock should for the time being be left to one side and a documentary check should be permitted during transport;

The effectiveness of the faecal indicator bacteria and their numerical limits as well as the other parameters laid down in this Chapter must be kept under constant review and, where scientific evidence proves the need to do so, be revised following the procedure laid down in Article 12 of this Directive. When there is scientific evidence indicating the need to introduce other health checks or to amend the parameters in this Chapter for the purpose of protecting public health, such measures must be adopted in accordance with the procedure laid down in

Whereas Directive 89/437/EEC (11) requires Member States to ensure that checks are conducted to detect residues of substances having a pharmacological or hormonal action, antibiotics, pesticides, detergents and other substances harmful or likely to alter the organoleptic characteristics of egg products or make the consumption of such products dangerous or harmful to human health;

I, the undersigned official veterinarian, certify that the fresh meat described above includes meat imported into Switzerland from the following third country(ies)... and/or the following Member States of the European Communities... between the following dates... 19.. and... 19.. of the fresh meat in Switzerland the responsible veterinary authorities of Switzerland carried out the appropriate checks having the same effect as the checks required by the European Communities in similar circumstances to ensure that the fresh meat satisfied the requirements of Directive 72/462/EEC including public health conditions laid down in Article 4 and specific animal health conditions laid down pursuant to Article 16, or of Directive 64/433/EEC and of Article 3 and 4 of Directive 72/461/EEC.

come from (an) establishment(s) having an individual facility for water treatment by chlorination, providing the supply of drinking water within the meaning of Directive EEC, and the owner of which is requested to carry out a daily check of the residual chlorine level, and to have carried out, in an official laboratory of the Ministry of Health, monthly checks in respect of the microbiological parameters;

Whereas, to supplement the information available to workers so as to ensure an improved level of protection, it is necessary for workers and their representatives to be informed about the risks which chemical agents can pose for their safety and health and about the measures necessary to reduce or eliminate those risks, and for them to be in a position to check that the necessary protective measures are taken;

Member States shall ensure that the plant health checks referred to in Article 12(6), fourth subparagraph of Directive 77/93/EEC, of plants, plant products or other objects listed in Annex V, part B of the said Directive and coming from third countries, and carried out at inspection posts other than those at the place of destination, satisfy at least the minimum conditions laid down in the Annex to this Directive.

Where the competent authority finds, in the course of checks carried out in accordance with Chapter V of Annex I, that there is repeated non-compliance during self-monitoring with the criteria laid down in Annexes II and IV, it shall intensify the measures for monitoring the production of the establishment in question, and may seize the labels and other items bearing the health mark referred to in Chapter VI of Annex I.

the check referred to in Article 4 shows to the satisfaction of the veterinarian, if applicable after the animals have passed through a quarantine centre, that the animals fulfil the requirements of this Directive or, in the case of animals referred to in Annex A to Directive 90/425/EEC, afford health guarantees recognized in accordance with the procedure laid down in Article 23 as being at least equivalent to those requirements;

Product information (Summary of Product Characteristics (SPC) and Package Leaflet) Healthcare professional information regarding Volibris Pre-prescription checklist for physicians Information about the post marketing surveillance study Information booklets for patients Information booklets for male partners of female patients with childbearing potential Patient reminder cards Pregnancy reporting forms Adverse drug reaction reporting forms

by withdrawal of a border inspection post, where it is found not to be complying with the conditions laid down in Annex II, either during a check carried out by the competent authority or if, following the inspections provided for in Article 23, the Member State does not take account of the conclusions of this inspection within a reasonable time especially in cases where the inspections have resulted in a serious public or animal health risk.

• Product information (Summary of Product Characteristics (SPC) and Package Leaflet) • Healthcare professional information regarding Volibris • Pre-prescription checklist for physicians • Information about the post marketing surveillance study • Information booklets for patients • Information booklets for male partners of female patients with child-bearing potential • Patient reminder cards �� Pregnancy reporting forms • Adverse drug reaction reporting forms

Whereas, in particular, if the customs authorities find, when carrying out checks in connection with releases for free circulation, that goods display certain characteristics which would give rise to a serious doubt as to the existence of a serious and immediate risk to health and safety, these authorities must be in a position to suspend the release of those goods and to inform the national authorities responsible for monitoring the market so that the latter may take suitable action;

In accordance with the procedure laid down in Article 29, derogations may be granted from the provisions of Article 6(1)(b) and, as regards the staff responsible for carrying out the checks and for issuing certificates, from those of Article 4(1) and Article 5(1) for border inspection posts where fish are presented in accordance with Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (21).

For the purposes of this Directive the definitions in Article 2 of Directive 89/662/EEC and Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (7), and the definition of fresh meat in Article 2 (b) of Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (8), shall apply as necessary.

For ovine and caprine animals for fattening and breeding dispatched to another Member State from an approved assembly centre located in the Member State of origin, the health certificate referred to in paragraph 1, conforming to either model II or III set out in Annex E as appropriate, may only be issued on the basis of the checks provided for in paragraph 3 and of an official document containing the necessary information completed by the official veterinarian responsible for the holding of origin.

Whereas, to maintain the health situation in the Community, when the animals and products of animal origin referred to in this Directive are placed on the market, they should be made subject to the minimum requirements laid down for trade and compliance therewith monitored in accordance with the principles and rules laid down in 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 (8);

Whereas, in order to permit better management of imports of calves outside the quotas, it should be laid down that for all calves weighing not more than 300 kilograms included in the import licence the country of provenance must be indicated in box 7 and in box 8 the country of origin, which must correspond to the exporting country on the 'animal health certificate` specified in the Annex to the abovementioned decisions, and it should also be checked that, at the time of entry into free circulation, the country of origin indicated on the import licence conforms with the exporting country specified on the original or the copy of the animal health certificate and, where any discrepancy is found between these two countries, entry into free circulation should be refused;

For ovine and caprine animals for slaughter dispatched to another Member State from an approved assembly centre or from an approved dealer's premises located in the Member State of origin, the health certificate referred to in paragraph 1, conforming to model I set out in Annex E, may only be issued on the basis of the checks provided for in paragraph 3 and of an official document containing the necessary information completed by the official veterinarian responsible for the holding of origin or the assembly centre referred to in Article 4c(3)(a)(i).

• drug distribution will only be possible after checking that the patient has effectively received a meningococcal vaccination with a written confirmation • prior to distribution, all health care professionals are provided with information on the following key safety concerns: o Headache o Infusion reaction o Neisseria and general infection o Risk of serious haemolysis following eculizumab discontinuation and proposed management o Pregnancy and need of adequate contraception in women of childbearing potential o Immunogenicity o Renal and hepatic impairment.

Whereas all pure-bred breeding animals entering the Community are checked for veterinary and zootechnical reasons at the first point of entry, according to Council Directive 91/496/EEC (5), as last amended by Directive 96/43/EC (6), and when these animals are put into free circulation in a customs office other than the first point of entry, it is necessary that an authenticated copy of the health certificate, since the original will be kept at the first point of entry, and a certificate drawn up in conformity with Commission Decision 92/527/EEC (7), shall accompany the animal;

It is necessary to lay down the conditions under which registered horses may be transported without compromising the health status of those animals during the journey by sea from the port of Cape Town situated in the free zone to a harbour in the European Union approved as border inspection post in accordance with Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC(9), as last amended by Directive 96/43/EC(10).

In accordance with Article 3 of Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries(7), and with Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC(8), imports may be authorised only for products meeting the requirements of the veterinary rules and certification currently in force in the Community.

Whereas, in the framework of the on-the-spot checks provided for in Article 12 of Directive 64/433/EEC and in Article 10 of Council Directive 71/118/EEC of 15 February 1971 on health problems affecting the production and placing on the market of fresh poultrymeat (3), as last amended by Directive 96/23/EC (4), the Commission may, without warning, verify the application of the provisions of Council Directive 85/73/EEC of 29 January 1985 on the financing of veterinary inspections and controls covered by Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and 91/496/EEC (5), as last amended by Directive 96/43/EC (6);

develop cooperation on animal and plant health, agrifood health (in particular ionization) including veterinary legislation and inspection, vegetal and phytosanitary legislation with the aim of bringing about gradual harmonization with Community standards through assistance for training and the organization of checks,

The Competent Authorities in each Member State shall ensure that imported peanuts originating in or consigned from China are subject to documentary checks to ensure that the requirement for the health certificate and sampling results referred to in paragraph 1 are complied with.

The competent authorities in each Member State shall ensure that imported dried figs, hazelnuts and pistachios, as mentioned in paragraph 1, originating in or consigned from Turkey are subject to documentary checks to ensure that the requirement for the health certificate and sampling results referred to in paragraph 1 are complied with.