approved country for importhas the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;
external usemeans application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur, and references to medicinal products being “for external use” shall be read accordingly—except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;
the Actmeans the Medicines Act 1968;