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Schedule 9A Meaning of terms used in the orphan criteria and in regulation 58DF1

  1. 1Prevalence of a condition in the United Kingdom
  2. 2Potential for return on investment
  3. 3Existence of other methods of diagnosis, prevention or treatment
  4. 4Increased safety or effectiveness and clinical superiority
  5. 5Paragraph 5
  6. 6Paragraph 6
  7. 7Paragraph 7
  8. 8Paragraph 8

Annotations

Textual amendments

F1

Sch. 9A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 191); 2020 c. 1, Sch. 5 para. 1(1)