Article 4 - Definitions

For the purposes of this Convention:

a) the term "medical product" shall mean medicinal products and medical devices;

b) the term "medicinal product" shall mean medicines for human and veterinary use, which may be:

(i) any substance or combination of substances presented as having properties for treating or preventing disease in humans or animals;

(ii) any substance or combination of substances which may be used in or administered to human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(iii) an investigational medicinal product;

c) the term "active substance" shall mean any substance or mixture of substances that is designated to be used in the manufacture of a medicinal product, and that, when used in the production of a medicinal product, becomes an active ingredient of the medicinal product;

d) the term "excipient" shall mean any substance that is not an active substance or a finished medicinal product, but is part of the composition of a medicinal product for human or veterinary use and essential for the integrity of the finished product;

e) the term "medical device" shall mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software, designated by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, designated by the manufacturer to be used for human beings for the purpose of:

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(iii) investigation, replacement or modification of the anatomy or of a physiological process;

(iv) control of conception;

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

f) the term "accessory" shall mean an article which whilst not being a medical device is designated specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by the manufacturer of the medical device;

g) the terms "parts" and "materials" shall mean all parts and materials constructed and designated to be used for medical devices and that are essential for the integrity thereof;

h) the term "document" shall mean any document related to a medical product, an active substance, an excipient, a part, a material or an accessory, including the packaging, labeling, instructions for use, certificate of origin or any other certificate accompanying it, or otherwise directly associated with the manufacturing and/or distribution thereof;

i) the term "manufacturing" shall mean:

(i) as regards a medicinal product, any part of the process of producing the medicinal product, or an active substance or an excipient of such a product, or of bringing the medicinal product, active substance or excipient to its final state;

(ii) as regards a medical device, any part of the process of producing the medical device, as well as parts or materials of such a device, including designing the device, the parts or materials, or of bringing the medical device, the parts or materials to their final state;

(iii) as regards an accessory, any part of the process of producing the accessory, including designing the accessory, or of bringing the accessory to its final state;

j) the term "counterfeit" shall mean a false representation as regards identity and/or source;

k) the term "victim" shall mean any natural person suffering adverse physical or psychological effects as a result of having used a counterfeit medical product or a medical product manufactured, supplied or placed on the market without authorisation or without being in compliance with the conformity requirements as described in Article 8.

<< Article 3 - Scope		>> Chapter II - Substantive criminal law
	Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health ETS No. 211 (Moscow,...