Chapter 3: Orphan Medicine Development in the UK
68
24. National Institute for Health and Care Excellence.
Interim Process and Methods of the Highly
Specialised Technologies Programme. May 2013.
NICE website. https://www.nice.org.uk/Media/
Default/About/what-we-do/NICE-guidance/
NICE-highly-specialised-technologies-guidance/
Highly-Specialised-Technologies-Interim-methods-
and-process-statements.pdf. Accessed 14 September
2021.
25. Patient and Clinician Engagement (PACE) Meetings
Overview. SMC website. https://www.scottishmedi-
cines.org.uk/media/5423/pace-overview-document-v32.
pdf. Accessed 14 September 2021.
26. Op cit 22.
27. Ibid.
28. AWMSG appraisal process for a medicine for a rare
disease. July 2019. AWMSG website. https://awmsg.
nhs.wales/files/appraisal-process/awmsg-appraisal-
process-for-a-medicine-for-a-rare-disease-pdf-500kb/.
Accessed 14 September 2021.
29. Mezher M. MHRA issues post-transition orphan,
Northern Ireland supply guidance. 1 October 2020.
Regulatory Focus. RAPS website. https://www.raps.
org/news-and-articles/news-articles/2020/10/mhra-is-
sues-post-transition-orphan-northern-irelan. Accessed
14 September 2021.
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