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Volume 7: Medicines and Cosmetics
Annex 2 to Chapter 6: Response to the Questionnaires
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Level of response to CSM questionnaire
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75% of licence holders had responded. |
574 products using animal ingredients; 17 containing UK only bovine ingredients; and 40 containing bovine ingredients of mixed origin. 176 products not conforming to guidelines, but only 2 of concern. |
Non-responses to be followed up before next meeting. |
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94% of licence holders had responded. |
No products using high-risk material that did not meet the guidelines; majority of non-compliant products used BSA/FCS. |
MCA to consider the 6% non-respondents. |
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Only 4 companies yet to respond. None of them were full licence holders. |
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Further information required from these 4 companies. |
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All outstanding replies received. |
Final 4 replies gave no cause for concern. |
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Date (relevant document/meeting)
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Level of response to VPC questionnaire
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August 1989. (Letter from Dr Lee to Mr Armstrong) |
186 of 245 licensees had responded, accounting for 3,239 products. |
303 products contain material of bovine, ovine or caprine origin. |
Reminders to be sent to 59 non-respondents. Follow-up letters to be sent to companies where further information required. Initial analysis of responses to begin soon. |
September 1989. (Dr Lee's summary paper to BSEWG) |
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45 bovine or ovine ingredients identified, the most common being bovine serum (86 products). |
More information needed from some companies. Effort would focus on products with most risk of BSE contamination. |
December 1989. (Dr Lee's update) |
190 licensees had replied by this point. |
348 medicines with animal material, of which 302 contained bovine/ovine/caprine material. |
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December 1990. (VMD report to VPC meeting) |
Most companies have now made satisfactory arrangements to comply with the guidelines. |
A number of specific products were mentioned that required attention. These are dealt with in the narrative. |
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Level of response to medical device questionnaire
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46 companies used animal material. 26 used bovine material of which 2 sourced from the UK using pericardium tissue. |
Definitive list of non-responders to be drawn up and second reminder sent. |
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All companies who had been sent the questionnaire had responded. |
76 products using animal materials. 34 of bovine origin, but only 13 of these from the UK or Europe. Only 2 with UK bovine material as a major component. |
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PD/STD meetings with the two manufacturers with products having bovine material as a major component. |
July 1990 (Memo by Mr Burton) |
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1 company had changed to non-UK source material (January) and the other had ceased production (April). |
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Source: Compiled by the Inquiry from documents referred to in Chapter 6
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