ANNEX

Medicinal products developed by means of one of the following biotechnological processes: recombinant DNA technology, controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells, hybridoma and monoclonal antibody methods. Veterinary medicinal products, including those not derived from biotechnology, intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals. Medicinal products developed by other biotechnological processes which, in the opinion of the Agency, constitute a significant innovation. Medicinal products administered by means of new delivery systems which, in the opinion of the Agency, constitute a significant innovation. Medicinal products presented for an entirely new indication which, in the opinion of the Agency, is of significant therapeutic interest. Medicinal products based on radio-isotopes which, in the opinion of the Agency, are of significant therapeutic interest. New medicinal products derived from human blood or human plasma. Medicinal products the manufacture of which employs processes which, in the opinion of the Agency, demonstrate a significant technical advance such as two-dimensional electrophoresis under micro-gravity. Medicinal products intended for administration to human beings, containing a new active substance which, on the date of entry into force of this Regulation, was not authorized by any Member State for use in a medicinal product intended for human use. Veterinary medicinal products intended for use in food-producing animals containing a new active substance which, on the date of entry into force of this Regulation, was not authorized by any Member State for use in food-producing animals.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.