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[11] Omnibus Motion, pp. 18-19 citing Adm. Order No. 67, (1989) and Bureau Circ.
No. 5 (1997).
[12] Defined in Adm. Order No. 67 (1989), sec. 3, 3.2.2 as "a new chemical or
structural modification of a Tried and Tested or Established Drug proposed to be used
for a specific therapeutic indication, which has undergone adequate clinical
pharmacology Phase I, II and III studies but which needs further Phase IV Clinical
Pharmacology studies before it can be given regular registration."
[13] Omnibus Motion, pp. 20-24 citing Adm.Order No. 67 (1989) and Bureau Circ.
No. 5 (1997).
[14] The Responsible Parenthood and Reproductive Health Act of 2012.
[15] See Rep. Act No. 10354, sec. 4(a) which provides:
Section 4. Definition of Terms - For purposes of this Act, the following shall be
defined as follows:
(a) Abortifacient refers to any drug or device that induces abortion or the destruction
of a fetus inside the mother's womb or the prevention of the fertilized ovum to reach
and be implanted in the mother's womb upon determination of the FDA.
[16] See Rep. Act No. 10354, sec. 3(e).
[17] Omnibus Motion, pp. 12-13.
[18] Implementing Rules and Regulations of Rep. Act No. 10354, sec. 7.04.
[19] Implementing Rules and Regulations of Rep. Act No. 10354, sec. 7.05.
[20] OSG Omnibus Motion, pp. 13-14, rollo, pp. 418-419.
[21] Implementing Rules and Regulations of Rep. Act No. 10354, sec. 7.04.
[22] Implementing Rules and Regulations of Rep. Act No. 10354, sec. 7.04.
[23] Implementing Rules and Regulations of Rep. Act No. 10354, sec. 7.04.
[24] OSG Omnibus Motion, pp. 13-14, rollo, pp. 418-419.
[25] OSG Omnibus Motion, pp. 13-14, rollo, pp. 418-419.
4/21/2020, 9:19 AM
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