The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
38 Amendment of Schedule 24
In Schedule 24 (packaging information requirements), after Part 5 insert— Part 6 Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only 54. The name of the medicinal product. 55. The strength and pharmaceutical form of the product. 56. Where appropriate, whether the product is intended for babies, children or adults. 57. The expiry date, including the year and month and, if applicable, the day or time in hours and minutes. 58. Where the product contains up to three active substances, the common name of each active substance. 59. A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names. 60. The pharmaceutical form and the contents by weight, by volume or by number of doses of the product. 61. A list of— (a) where the product is injectable or is a topical or eye preparation, all excipients; or (b) in any other case, those excipients known to have a recognised action or effect and included in the guidance published under regulation 257D that is applicable to such products. 62. The method of administration of the product and if necessary the route of administration. 63. Where appropriate, space for the prescribed dose to be indicated. 64. A warning that the product must be stored out of the reach and sight of children. 65. Any special warning applicable to the product. 66. Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place. 67. The name and address of the holder of the UK marketing authorisation relating to the product and, where applicable, the name of the holder’s representative. 68. The number of the UK marketing authorisation for placing the product on the market. 69. The manufacturer’s batch number or other product identifier. 70. The patient’s name and unique patient identifier. Part 7 Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only) 71. The name of the medicinal product. 72. The strength and pharmaceutical form of the product. 73. Where appropriate, whether the product is intended for babies, children or adults. 74. The expiry date, including the year and month and, if applicable, the day or time in hours and minutes. 75. Where the product contains up to three active substances, the common name of each active substance. 76. The method of administration of the product and if necessary the route of administration. 77. The name of the holder of the UK marketing authorisation relating to the product. 78. The manufacturer’s batch number or other product identifier. 79. The contents of the packaging by weight, by volume or by unit. 80. The patient’s name and unique patient identifier. .
38 Amendment of Schedule 24
In Schedule 24 (packaging information requirements), after Part 5 insert— Part 6 Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only 54. The name of the medicinal product. 55. The strength and pharmaceutical form of the product. 56. Where appropriate, whether the product is intended for babies, children or adults. 57. The expiry date, including the year and month and, if applicable, the day or time in hours and minutes. 58. Where the product contains up to three active substances, the common name of each active substance. 59. A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names. 60. The pharmaceutical form and the contents by weight, by volume or by number of doses of the product. 61. A list of— (a) where the product is injectable or is a topical or eye preparation, all excipients; or (b) in any other case, those excipients known to have a recognised action or effect and included in the guidance published under regulation 257D that is applicable to such products. 62. The method of administration of the product and if necessary the route of administration. 63. Where appropriate, space for the prescribed dose to be indicated. 64. A warning that the product must be stored out of the reach and sight of children. 65. Any special warning applicable to the product. 66. Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place. 67. The name and address of the holder of the UK marketing authorisation relating to the product and, where applicable, the name of the holder’s representative. 68. The number of the UK marketing authorisation for placing the product on the market. 69. The manufacturer’s batch number or other product identifier. 70. The patient’s name and unique patient identifier. Part 7 Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only) 71. The name of the medicinal product. 72. The strength and pharmaceutical form of the product. 73. Where appropriate, whether the product is intended for babies, children or adults. 74. The expiry date, including the year and month and, if applicable, the day or time in hours and minutes. 75. Where the product contains up to three active substances, the common name of each active substance. 76. The method of administration of the product and if necessary the route of administration. 77. The name of the holder of the UK marketing authorisation relating to the product. 78. The manufacturer’s batch number or other product identifier. 79. The contents of the packaging by weight, by volume or by unit. 80. The patient’s name and unique patient identifier. .
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