Glossary

Tissues removed and transplanted back to the same individual

(Directive 2004/23/EC, preamble, paragraph 8 [242 KB] )

Biosafety Clearing House

Competitiveness in Biotechnology Advisory Group with Industry and Academia

The formation of a hybrid cell produced by fusing two different cells (European Commission. Biosociety Research Online, Bio-glossary).

Committee for Medicinal Products for Human Use

Committe for orphan Medicinal Products

Community Plant Variety Office

Community Reference Laboratory

Committee for Medicinal Products for Veterinary Use

Dangerous Goods Safety Adviser

European Medicines Agency

Environmental Risk Assessment

Uses purified preparations of a gene or a fraction of a gene to treat a disease. This can be done either by correcting the functioning of a cell in which a single gene does not work properly from birth or sometimes by killing a cell which is out of control. (Gene Therapy: The Great Debate, 2nd Edition, 1996 ).

A gene therapy product is defined in Annex I to Directive 2001/83/EC as .a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo.

Gene therapy may be redefined under forthcoming legislation. Related approaches such as RNA interference (RNAi) technology are emerging, and may in the future be applied therapeutically.

Good laboratory practice

Genetically modified micro-organism

Genetically modified organism

Good Manufacturing Practices

Committee for Herbal Medicinal Products

Joint Research Centre

The order of occurrence of chemical residues, known as nucleotides or bases, in DNA or RNA.

Patent Cooperation Treaty

Research and Development

The removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants. Self-cloning may include the use of ecombinant vectors with an extended history of safe use in the particular micro-organisms. (Directive 98/81/EC, Annex II, Part A ).

Cells other than sperm or egg cells, which are not naturally involved in conceiving children.

Use in humans of autologous (emanating from the patient himself), allogenic (coming from another human being), or xenogenic (coming from animals) somatic living cells, the biological characteristics of which have been substantially altered as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect through metabolic, pharmacological and immunological means (Directive 2003/63/EC, Annex, Point 2 ).

International Convention for the Protection of New Varieties of Plants