| Table 2 Part B |
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Medicinal products developed by other biotechnological processes which, in the opinion of the Agency, constitute a significant innovation. |
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Medicinal products administered by means of new delivery systems which, in the opinion of the Agency, constitute a significant innovation. |
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Medicinal products presented for an entirely new indication which, in the opinion of the Agency, is of significant therapeutic interest. |
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Medicinal products based on radioisotopes which, in the opinion of the Agency, are of significant therapeutic interest. |
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| New medicinal products derived from human blood or human plasma. |
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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 microgravity. |
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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. |
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Veterinary medicinal products intended for use in food-processing 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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| Annex, Part B of Council Regulation (EEC) 2309/93 of 22 July 1993. |