Elevit Pre-conception and Pregnancy, Bayer Australia Ltd, CON-884
Product name
Elevit Pre-conception and Pregnancy
Sponsor name
Bayer Australia Ltd
Consent start
Consent no.
CON-884
Standard
Subsections 17(1) and 20(a) of Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
Non-compliance with standard
The Medicine does not conform to the requirements stated in subsections 17(1)
and 20(a) of Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO
101) Order 2019 in thatSubsection 17(1) - Dissolution testing of all actives.
The proposed tests and limits as below Dissolution testing of all actives to be
replaced with dissolution testing for folic acid, riboflavin (index vitamin) and
iron (index mineral) as per Disintegration and dissolution of dietary
supplements of the United States Pharmacopeia-National Formulary, Dietary
Supplement Chapter lt;2040gt;Subsection 20(a) - Uniformity of dosage units. The
proposed tests and limits as below Uniformity of mass as per Appendix XII C.
Consistency of formulated preparations of the BP - Uniformity of mass
(Ph.Eur.2.9.5)
Conditions imposed
* The goods are not required to comply with subsection 17(1) of the TGO 101
but must comply with the dissolution requirements of the United
StatesPharmacopeia-National Formulary, Dietary Supplement Chapter
lt;2040gt;'Disintegration and Dissolution of Dietary Supplements' for folic
acid,riboflavin (index vitamin) and iron (index mineral);
* The goods are not required to comply with subsection 20(a) of the TGO 101
but must comply with the requirements of the Appendix XII C. Consistency
offormulated preparations of the BP - Uniformity of Weight (mass), Ph.
Eur.method 2.9.5.
Therapeutic product type
Registered complementary medicines