S.L. 458.34 Art. 2Interpretation.

(1) For the purposes of these regulations -

''abuse of medicinal products'' means persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects;

''advanced therapy medicinal product'' means a product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products ''Annex I'' means Annex I of Directive 2001/83/EC as subsequently amended and as appearing in the Schedule; ''the Act'' means the Medicines Act;

''the Agency'' means the European Medicines Agency established by Regulation (EC) No 726/2004; ''the Authority'' means the Medicines Authority established under article 4 of the Act; ''the Commission'' means the Commission in accordance with Council Decision 1999/468/EC of 28 June, 1999; ''the Community'' means the European Union, previously referred to as the European Community and the European Economic Community; ''common name'' is the international non-proprietary name recommended by the World Health Organisation, or if it does not exist, the usual common name;

''co-ordination group'' means the co-ordination group set up in accordance with Article 27 of Directive 2001/83/EC as amended by Directive 2004/27/EC; ''global marketing authorisation'' means the marketing authorisations containing the initial marketing authorisation and all variations and extensions thereof, as well as any additional strengths, pharmaceutical forms, administration routes or presentations authorised through separate procedures and under a different name, granted to the marketing authorisation holder of the initial authorisation;

''homeopathic medicinal product'' means any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles; ''Licensing Authority'' means the Licensing Authority referred to in article 3 of the Act; ''medicinal product'' shall have the same meaning as defined by the Act; ''Member State'' means a State, which is a member of the European Union, and shall also include Iceland, Norway and Liechtenstein;

"Pharmacovigilance system" means a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in these regulations and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance;

"Pharmacovigilance system master file" means a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products; "post-authorisation safety study" means any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures; ''reference Member State'' means the Member State which, for a given medicinal product, has produced the assessment report, which serves as the basis for the mutual recognition procedure and the decentralised procedure; ''representative of the marketing authorisation holder'' means the person commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned;

''risk-benefit balance'' means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks relating to the quality, safety and efficacy of the medicinal product as regards patients’ health or public health; "risk management system" means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions; "risk management plan" means a detailed description of the risk management system; ''risks related to use of the medicinal product'' means any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health or any risk of undesirable effects on the environment; ''strength of the medicinal product'' means the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form; ''the Superintendent'' means the Superintendent of Public Health.

(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 of

Directive 2001/20/EC 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 for 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;

(h) any advanced therapy medicinal product, as defined in Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality standards, and used in Malta in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient. The manufacturing of these products shall be authorised by the Licensing Authority in Malta.