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#1 Posted : 26 April 2005 13:43:00(UTC)
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Posted By Shelagh O'Sullivan We receive e.g. bulk tablets for packaging into final marketed packs. In the final pack, they are exempt from CHIP regs but in the bulk tablet form they should be classified as any other chemical preparation and supplied with a SDS and hazard labelling as appropriate. I have reached this interpretation of the CHIP regs with the agreement of our Dangerous Goods Advisor. However, the materials supplied to us are often not classified, no hazard labels, no SDS. Suppliers often dispute that such materials are regulated under CHIP. I'm sure I'm right on this but the number of disputes I have is making me question myself. Any comment/opinion from DGAs and suppliers of such products would be appreciated. Thanks Shelagh
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#2 Posted : 26 April 2005 14:33:00(UTC)
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Posted By Richie Shelagh, I have just pulled the chip regs 02' and they do not differentiate between bulk or small quantities of medicines, so long as they are for use as medicines. Here is the SI passage: (3) These Regulations shall not apply to a substance or preparation which is - (a) intended for use as a medicinal product within the meaning of section 130 of the Medicines Act 1968[12]; (b) specified in an order made under section 104 or 105 of the Medicines Act 1968 which is for the time being in force and which directs that specified provisions of that Act shall have effect in relation to that dangerous substance or dangerous preparation as such provisions have effect in relation to medicinal products within the meaning of that Act; (c) a controlled drug within the meaning of the Misuse of Drugs Act 1971[13] except that these Regulations shall apply to drugs which are excepted from section 4(1)(b) of that Act (which makes it unlawful to supply a controlled drug) by Regulations made under section 7(1)(a) of that Act; You may be thinking of bulk products prior to being formulated into medicines, but I know of no trigger quantities once classified as medicines. I have to say, however, that we are all on a learning curve, and there is always the possibility that i am totally wrong. Having said that though, I feel comfortable in my interpretation of chip in this instance. Richie
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#3 Posted : 26 April 2005 15:24:00(UTC)
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Posted By Shelagh O'Sullivan Dear Richie Thanks for the response. I am definitely referring to formulated products, not raw materials. The products require packaging and as such if, for e.g the hazardous ingredient is classified with R22, R36/37/38, and the formulated product contains e.g. 50% of that hazardous ingredient, then I cannot see that it can be exempted from CHIP as it is likely to generate hazardous dusts in the handling/processing stages of the packaging operation. If these tablets are not governed by CHIP, and we receive containers of dusty tablets, which contain 50% hazardous ingredient, how do we, as the next in the supply chain, perform the COSHH assessment and apply correct controls if we have no hazard data from the supplier to start with? I admit that I have to brush up on the sections you have quoted from the Medicines Act 1968. Any more opinions very welcome. Shelagh
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#4 Posted : 26 April 2005 15:43:00(UTC)
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Posted By Paul Leadbetter Shelagh Whether or not the materials in question are covered by CHIP, you are right to say that they need a COSHH assessment. If the manufacturers are using the fact that these substances are medicines as a get-out for not supplying MSDSs under CHIP, what about their section 6 HASAWA duty to provide information? If the information is still not forthcoming, at least get the name of the hazardous ingredients to enable you to search the internet for the required information. Paul
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#5 Posted : 26 April 2005 16:30:00(UTC)
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Posted By Robin B Hi Shelagh We have a somewhat similar problem with raw materials for medicinal formulations. Sometimes MSDS's are extremely hard to get a hold of [like the end of the rainbow]. In the same circumstances as you, I check the various MSDS sites on the web and although not ideal it does give the basis for making an assessment. Some of our colleagues would perhaps tell us simply to change our supplier, but we know that sometimes there is only one supplier world wide. But I do agree with your conclusions. POM's are excluded from Chip after final pack but should be classed as a raw material up to that point. That of course means COSHH comes into play and most likely as a higher catagory of risk as many of these raw materials and formulations are designed to have some effect on the body. As far as transportation is concerned some years ago medicines were exempt from the strictures of ADR - but only those classed as toxic and perhaps radioactive. However, I cant find that particular exclusion in the 2005 ADR. Don't doubt Robin
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