S.L. 458.36 чл. 2Interpretation.

For the purposes of these regulations -

"Act" means the Medicines Act;

"active substance (API)" means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis; "the Agency" means the European Medicines Agency established by Regulation (EC) No. 726/2004;

"the Commission" means the Commission in accordance with Council Decision 1999/468/EC of 28th June, 1999;

"the Community" means the European Community and the European Economic Area;

"imported medicinal products" means medicinal products obtained from a source outside the European Union or the European Economic Area; "Member State" means a State which is a member of the European Union and includes Iceland, Norway and Liechtenstein.

(2) The provisions of these regulations shall not apply to:

(a) any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula);

(b) any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question, (commonly known as the officinal formula);

(c) medicinal products intended for research and development trials but without prejudice to the provisions of the Clinical Trials Regulations, or Directive 2001/20/EEC of the European Parliament and of the Council of the 4th April, 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products on human use;

(d) intermediate products intended for further processing by an authorised manufacturer;

(e) any radionuclides in the form of sealed sources;

(f) whole blood, plasma or blood cells of human origin, except for plasma which is prepared by a method involving an industrial process;

(g) medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.