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[接上页] Scale I Scale II Scale III subject to section 4(2) Scale IV Cap 478X s 5 Standards of medicines and medical stores All medicines and other medical stores required by this Regulation to be kept on board a ship shall conform to the standards and requirements of the British National Formulary or the British Pharmacopoeia or the European Pharmacopoeia or the United States Pharmacopoeia and with the requirements of and with the specifications set out in Schedules 1, 2, 3 and 4. (Enacted 1996) Cap 478X s 6 Packaging and labelling of containers (1) Without prejudice to any other enactment, any container of medicines or other medical stores required by section 4 to be kept on board a ship- (a) shall have, in the English language, on a label the particulars specified in subsection (3); (b) in the case of a container of tablets or capsules, shall be capable of reclosure to prevent ingress of moisture; (c) in the case of a container of disinfectant, shall not show deleterious reaction with the disinfectant after storage in normal conditions for 6 months or less; (d) in the case of a container of insecticide, shall be air-tight, water-tight, packed in a suitable and sturdy case and, if the container is a pressure canister, have a cap or other means of protecting the valve against accidental opening when the canister is not in use; and (e) in the case of medicine or disinfectant not in the container supplied by its manufacturer, shall be packed in a sturdy, brown-coloured or non-translucent container.(2) Any label referred to in subsection (1)(a) shall either be firmly affixed to the container and rendered resistant to moisture by varnish or other effective means or be an integral part of the container. (3) The particulars required by subsection (1)(a) to be shown on labels are- (a) the ordering name by which the medicine or medical store is referred to in Schedules 1 and 2; (b) any storage requirements laid down in any of the publications referred to in section 5, elsewhere in this Regulation or in Schedule 1; (c) if the medicines or medical stores are perishable, the expiry date as defined in section 8; (d) the name and address of the supplier of the medicines and medical stores, the product licence number and batch number; (e) in the case of any container of a disinfectant or of an antiseptic prescribed in any of the scales set out in Schedule 1, the dilution recommended for any purposes stated thereon; (f) in the case of any container of an insecticide prescribed in any of the scales set out in Schedule 1, instructions for use and precautions to be taken as detailed in Schedule 4; (g) in the case of a container of hypochlorite, a notice indicating that the chemical may combust spontaneously and that the hypochlorite should be stored in a cool, dark place; and (h) any further information required by Schedules 1, 3 and 4. (Enacted 1996) Cap 478X s 7 Storage of medicines (1) Any medicine or medical store shall be stored in accordance with any instructions on its container or prescribed in Schedule 1. (2) Any medicine shall, where applicable, be stored in accordance with the requirements for controlled drugs contained in the Ship Captain's Medical Guide, and subject thereto, unless it is required to be kept in a refrigerator or in a first aid satchel or box, shall be stored- (a) in the medical cabinet if, under the Merchant Shipping (Seafarers) (Crew Accommodation) Regulation (Cap 478 sub. leg.), the ship is required to have a medical cabinet; or (b) in a cool, dry, locked cabinet or locked container.(3) Any medicines or medical stores kept in a hyperbaric decompression chamber or otherwise in such a way as not to be readily accessible at all times to the master or any person authorized by him shall not be taken into account in respect of the requirements of section 4. (Enacted 1996) Cap 478X s 8 Replenishment of dated medicines (1) Where- (a) a ship is required pursuant to section 4 to have on board any medicine or other medical stores in accordance with any of the scales set out in Schedule 1 or 2; and (b) any label required by section 6(1)(a) to be borne by any container of any such medicine or other medical stores, indicates a date after which the medicine or other medical store contained in it is not to be used (hereafter called "the expiry date"),that medicine or medical store shall be replaced at the earliest possible date after the expiry date, and in any case within 3 months of the expiry date. (2) Medicines or medical stores which have passed the expiry date shall, once replacements have been obtained, or after 3 months, whichever is the earlier, be disposed of in accordance with the Ship Captain's Medical Guide. (Enacted 1996) Cap 478X s 9 Offences PART III MISCELLANEOUS (1) Where any requirement under section 4, 5, 6, 7 or 8 is contravened in respect of a ship, the owner of the ship commits an offence and is liable on conviction to a fine at level 4. (2) It shall be a defence for any person charged in connection with a contravention of section 4 to show that the deficiency was caused by medicines and medical stores being used for their purpose and that it has not been reasonably practicable to replace them. |