S.L. 458.37 Art. 2Interpretation.

For the purposes of these regulations -"the Agency" means the European Medicines Agency established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

"applicant" includes a holder or licensee; "the Commission" means the Commission in accordance with Council Decision 1999/468/EC of the 28th June, 1999; "Member State" means a State which is a member of the European Union and includes Iceland, Norway and Liechtenstein; "responsible person" means a person registered as a pharmacist with the Pharmacy Council and recognised as suitable by the Medicines Authority since such person possesses adequate knowledge of the conditions required for the storage and distribution of medicinal products in order to avoid their deterioration or damage, has adequate knowledge of the regulations concerning the distribution of medicinal products, and has knowledge and understanding of good distribution practice.