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Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)

May 2013

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Appendix 3

New or amended advisory statements that may have significant impact on many sponsors
Substance Change type Source Likely impact

Anticholinergics, including:

  • Atropa belladonna;
  • Atropine compounds (excluding atropine methonitrate)
  • Datura spp.;
  • Hyoscine compounds;
  • Hyoscyamine compounds;
  • Hyoscyamus niger.
New entries NDPSC recommendation Sponsors will need to change labelling of their current marketed products

Antihistamines including:

  • Brompheniramine
  • Chlorpheniramine
  • Dexchlorpheniramine
  • Diphenhydramine
  • Doxylamine
  • Pheniramine
  • Promethazine
  • Triprolidine
New entries Recommended as consequence of TGA review of cough and cold medicine for use in children Sponsors have already been required to change labelling of their current marketed products via individual section 28 Notices

Antitussives including:

  • Codeine
  • Dextromethorphan
  • Dihydrocodeine
  • Pentoxyverine
  • Pholcodeine
New entries Recommended as consequence of TGA review of cough and cold medicine for use in children Sponsors have already been required to change labelling of their current marketed products via individual section 28 Notices
Benzydamine New entry ARGOM 2003, OTC evaluation Sponsors may need to change labelling of their current marketed products
Carthamus tinctorius flower New entry Recommendation from Advisory Committee on Complementary Medicines (ACCM) to include warning statement Sponsors should not need to change the labelling of their products as the sponsors have been advised that the required warning statement is to commence from 1 July 2011.
Chlorhexidine New entry Amendment Recommended by the Medicines Evaluation Committee (now ACNM) and the Adverse Drug Reaction Advisory Committee (now ACSOM) Sponsors will need to change labelling of their products
Choline salicylate New entry Recommended by ACNM as a consequence of safety review Sponsors will need to change labelling of their products
Coal tar New entry OTC evaluations Sponsors will need to change labelling of their current marketed products
Diclofenac New entry Recommended by ACNM as a consequence of safety review Sponsors will need to change labelling of their current marketed products

Decongestants including:

  • Oxymetazoline
  • Phenylephrine
  • Pseudoephedrine
  • Xylometazoline
New entries Recommended as consequence of TGA review of cough and cold medicine for use in children Sponsors have already been required to change labelling of their current marketed products via individual section 28 Notices

Expectorants/mucolytics

  • ammonium chloride
  • bromhexine
  • Guaifenesin
  • Ipecacuanha
  • Senega and ammonia
New entries Recommended as consequence of TGA review of cough and cold medicine for use in children Sponsors have already been required to change labelling of their current marketed products via individual section 28 Notices
Fexofenadine New entry Recommended as consequence of down-scheduling decision, but also applied to current schedule 2 medicines Sponsors will need to change labelling of their current marketed products
Fluorides Amendment to include new warning statement Update of ARGOM Sponsors will need to change labelling of their current marketed products
Flurbiprofen Amendment to include new warning stateme ARGOM 2003 Sponsors will need to change labelling of their current marketed products
Ibuprofen New entry Recommended by ACNM as a consequence of safety review Sponsors will need to change labelling of their current marketed products
Indomethacin New entry Recommended by ACNM in reviewing a dermal preparation of NSAID Sponsors will need to change labelling of their current marketed products
Ketoprofen Amendment to include new warning statement Recommended by ACNM as a consequence of safety review Sponsors will need to change labelling of their current marketed products
Lansoprazole New entry Newly scheduled substance in Schedule 3 of SUSMP Some sponsors may need to change labelling of their current marketed products impact if the current label does not already have the advisory statement.
Loratadine and desloratadine New entries Recommended as consequence of down-scheduling decision for loratadine, but also applied to current schedule 2 medicines Sponsors will need to change labelling of their current marketed products
Naproxen Amendment to include new warning statement ARGOM 2003 Sponsors will need to change labelling of their current marketed products
Naproxen New entry Recommended by ACNM as a consequence of safety review Sponsors will need to change labelling of their current marketed products
Pantoprazole New entry, Amendment to include new warning statement Newly scheduled substance in Schedule 3 of SUSMP Some sponsors may need to change labelling of their current marketed products impact if the current label does not already have the advisory statement.
Pyridoxal Amendment to replace existing statement with new statement Existing warning statements deemed ambiguous, propose new statements as replacement by ACCM Some sponsors will need to change labelling of their current marketed products impact if the current label does not already have the advisory statement.
Pyridoxine Amendment to replace existing statement with new statement Existing warning statements deemed ambiguous, propose new statements as replacement by ACCM Some sponsors will need to change labelling of their current marketed products impact if the current label does not already have the advisory statement.
Pyridoxamine Amendment to replace existing statement with new statement Existing warning statements deemed ambiguous, propose new statements as replacement by ACCM Some sponsors will need to change labelling of their current marketed products impact if the current label does not already have the advisory statement.
Rabeprazole New entry Newly scheduled substance in Schedule 3 of SUSMP Some sponsors may need to change labelling of their current marketed products impact if the current label does not already have the advisory statement.

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