CMA Advertising Seminar Permitted indications: What you can and cant - PowerPoint PPT Presentation

CMA Advertising Seminar Permitted indications: What you can and can’t say Adam Cook Complementary and OTC Medicines Branch Medicines Regulation Division, TGA May 2019

Implementation of permitted indications • The permitted indications reform commenced on 6 March 2018 . • All indications permitted for use by listed medicines are now contained in the Permissible Indications Determination . • Sponsors listing a medicine in the ARTG can only use indications from the permitted indications list • A ‘Free text” field is no longer available for new medicines. • Sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination - an application fee applies. 1 TGA / CMA Advertising Seminar – May 2019

What hasn’t changed - sponsor responsibilities • It is the sponsors responsibility to ensure the correct indications have been selected for their medicine. • Sponsors must continue to hold supporting evidence for all their medicine indications and other claims. • There must not be inconsistency between the indications that are included in the Register and on the label. • Sponsors are responsible for making sure that any advertising about their medicine (including the label) complies with the Advertising Code. 2

Legislation overview 3

Legislative requirements for listed medicines Is your medicine eligible for listing? Approved Preparation not in Qty restrictions Not required � ß ß ß ingredients Poison Standard not exceeded to be sterile � M ust only use permitted indications Sponsor certifies that the medicine is eligible for listing � Product is listed – assigned ARTG number (AUST L XXXX) 4 TGA / CMA Advertising Seminar – May 2019

Legislative amendments for permitted indications • Establishment of the list of permitted indications • Consequential amendments Conditions of listing § Cancellation provisions § • Application procedures for new indications Application form, fee and assessment criteria § • Transitional arrangements for existing products 5 TGA / CMA Advertising Seminar – May 2019

Legislative requirements for permitted indications • When applying to list a medicine applicants are required to certify under section 26A of the Act that: – Each indication entered in the Register is ‘covered by’ the Permissible Indications Determination. – Each indication included on the medicine label is ‘ covered by ’ the Permissible Indications Determination. – Each indication included on the medicine label is also included in the ARTG entry. 6 TGA / CMA Advertising Seminar – May 2019

Legislative requirements for permitted indications An indication is ‘covered by’ the Permissible Indications Determination when: a) It is specified in the determination (i.e. it is word for word ); OR a) It is a more specific version of an indication specified in the determination (i.e. uses optional indication qualifiers from the TGA Code Tables that specify a certain target population or time of use); OR a) When used on the medicine label, the indication does not differ in intent or meaning (i.e. indications on the label and in the Register are consistent ) 7 TGA / CMA Advertising Seminar – May 2019

Indications covered by the Determination For example: ARTG indication: Maintain/support gastrointestinal health a) Word for word: Maintain/support gastrointestinal health More specific version : Maintain/support gastrointestinal health in women b) c) Intent and meaning: � same intent and meaning: Maintains healthy gut ß different meaning: Maintain healthy intestinal flora 8 TGA / CMA Advertising Seminar – May 2019

Transition period for permitted indications • There is a 3 year transition period for existing listed medicines, ending 6 March 2021 . Changes to update indications before 6 September § 2019 can be done free of charge. On 7 March 2021 medicines that do not have § permitted indications will be cancelled from the ARTG. AUST L numbers will not change (where ‘grouping’ § applies) We will be holding a webinar on 7 May to provide sponsors guidance on how to transition to permitted indications in ELF - register via our website. 9 TGA / CMA Advertising Seminar – May 2019

Transition arrangements - product changes • Any product that is the subject to changes that make it a separate and distinct good under the Act must transition to permitted indications at the time of making the change. • These include changes to: – active ingredient or quantity of active ingredient – dosage form – product name – excipients – indications • Other product changes (9D variations) will not be required to transition at the time of the change. For more information see: Guidance on Product Changes 10 TGA / CMA Advertising Seminar – May 2019

Transition arrangements – when a fee applies Type of Change Fee Payable New ARTG Must transition to number issued? permitted indications? New Standard listing fee Yes Yes Grouping (indications Nil No Yes only) Yes as sponsors Grouping (other than Yes as is considered a Standard listing fee also required to indications) new product update indications Variation Standard variation fee No No Correction to ARTG Nil No No record 11 TGA / CMA Advertising Seminar – May 2019

The list of permitted indications 12

The list of permitted indications • The list of permitted indications is contained in a legislative instrument that provides: a comprehensive list of low risk indications that § must be used to list a medicine in the ARTG 'requirements’ relating to the use of indications § ‒ including general rules for how permitted indications are entered in the register and used on medicine labels 13 TGA / CMA Advertising Seminar – May 2019

What is an indication? • An indication describes the therapeutic use or claimed health benefit for a medicine. • Therapeutic use for listed medicines means use in, or in connection with, ‘influencing, inhibiting or modifying a physiological process in persons’ • Indications can be: specific (e.g. refer to a named non-serious condition); or § non-specific (e.g. general health maintenance) § For more information see the Permitted Indications Guidance 14 TGA / CMA Advertising Seminar – May 2019

Specific and non-specific indications • The Evidence guidelines for listed complementary medicines classifies indications as ‘specific’ and ‘non-specific’ � level of supportive evidence. • Permitted indications are not categorised as ‘specific’ or ‘non-specific’ because the overall presentation of a medicine needs to be considered. • For example: ‘ Decrease/reduce/relieve skin dryness ’ may be considered ‘non- specific’. However, if this indication is linked with ‘ Decrease/reduce/relieve symptoms of mild eczema/dermatitis ’ in the medicine ARTG entry and on the medicine label, then it is likely that such an indication would be considered specific. 15 TGA / CMA Advertising Seminar – May 2019

Criteria for permitted indications • Permitted indications meet the criteria for low-level indications: • Health enhancement , e.g. ‘ May reduce fatigue’ • Health maintenance , e.g. ‘ Helps support healthy joints’ • Prevention of dietary deficiency , e.g. ‘ May prevent calcium deficiency’ • A non serious form of a disease or ailment etc., e.g. ‘Helps decrease/ reduce/relieve symptoms of common cold’ • These are conditions that are self-diagnosable or self-manageable • There is an exception to this criteria is for three indications linked to substance-based restricted representation approvals (folic acid, calcium and vitamin D) For more information see the Permitted Indications Guidance 16 TGA / CMA Advertising Seminar – May 2019

Evidence requirements for permitted indications Must be supported by scientific evidence, such as clinical studies or systematic Scientific indications reviews, for example: ‘Help maintain/support bone mineralisation’. Must be supported by evidence of traditional use in a recognised paradigm outside modern conventional medicine. Indications can be used across different Traditional indications traditional paradigms, for example: ‘Blood cleanser/purifier’ Must be supported by evidence of traditional use within traditional Chinese Traditional Chinese medicine (TCM). These indications use specific terminology used in TCM, for Medicine indications example: ‘Traditionally used in Chinese medicine to disseminate Lung Qi’. Must be supported by evidence of traditional use within Ayurvedic medicine. Traditional Ayuvedic These indications use specific terminology used in Ayurvedic medicine, for Medicine indications example: ‘Traditionally used in Ayurvedic medicine to relieve aggravated Vata’. * Traditional medicines must include a traditional use qualifier in the ARTG and on the product label 17 TGA / CMA Advertising Seminar – May 2019