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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
11. Active ingredients for which bioequivalence data are generally not required
Applications to register immediate-release oral dose form (e.g. tablet, capsule, oral liquid or suspension) ‘generic’ products that contain active ingredients included in the list below would not usually require provision of bioequivalence data or a justification for not providing such data.
The below list has been determined in accordance with the guidelines detailed in 'Section 6.1 Bioequivalence data'.
- Bromhexine hydrochloride
- Brompheniramine maleate
- Chlorpheniramine maleate
- Codeine phosphate
- Dexchlorpheniramine maleate
- Dextromethorphan hydrobromide
- Diphenhydramine hydrochloride
- Docusate sodium
- Doxylamine succinate
- Hyoscine hydrobromide
- Hyoscine butylbromide
- Loperamide hydrochloride
- Naproxen sodium
- Phenylephrine hydrochloride
- Promethazine hydrochloride
- Pseudoephedrine hydrochloride
- Ranitidine hydrochloride
- Triprolidine hydrochloride
If, however, there is reason to consider that bioavailability of a proposed product might differ from existing products so as to impact on efficacy and/or safety (e.g. proposed novel dose form), bioequivalence data or a justification for not providing such data may be required despite inclusion of the relevant ingredient in the list. Further, where a proposed product is not a ‘generic’ of an existing product (e.g. a new combination product or strength), bioequivalence or other clinical data, or a justification for not providing such data, would be required despite inclusion of the relevant ingredient in the list.