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| Table 1 Part A |  |
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Medicinal products developed by means of one of the following biotechnological processes |
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recombinant DNA technology; |
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controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; and |
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hybridoma and monoclonal antibody methods. |
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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. |
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| | Annex, Part A of Council Regulation (EEC) 2309/93 of 22 July 1993. |
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products. Such biotechnology products are delineated in Part A of the Annex to the Regulation 2309/93, see Table 1. The procedure is also open by choice to products classed as high technology (Part B of the Annex to Regulation 2309/93) and new active substances, see Table 2. |
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A single European Marketing Authorization will be granted through this procedure and it will apply throughout the European Community. The authorization is renewable every 5 years on provision of a dossier containing up-to-date information including pharmacovigilance. The authorization also carries 10 year's exclusivity against cross referral to the data by another applicant. Once a product is authorized under the centralized procedure, further applications related to that product (e.g., new indications, new dosage forms, and variations to the authorization) must be filed under the same procedure. |
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The full procedure is explained in the Notice to Applicants currently under revision and expected to be reissued by mid-1996 [11]. The procedure itself, as detailed in the draft, is explained diagramatically in Figure 2. The main points are discussed below. |
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1. Verification of Part B Status |
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In the case of products possibly falling under the Part B classification, the applicant must apply for a ruling that the product concerned will be accepted for Part B by the Agency. This may be done at the time when the company is consulting the Agency on the development plans (e.g., for a very innovative product). Otherwise it will be necessary, even before the dossier is finalized, to provide a 23-page document describing the properties of the product in which the innovative character is described. The Agency will then advise on acceptability for Part B. |
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