Abstract
Knowledge of the new European Union (EU) procedures is vital for pharmaceutical companies. This paper summarizes and comments upon the Draft Notice to Applicants, chapters II and III, which serve as a guide to the new procedures. This document draws from a variety of regulations that are referenced in the newly issued chapters with the goal of identifying key issues that require clarification. The conditions for a community referral as an independent procedure in addition to national, centralized, and decentralized procedures are also described.
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References
1.
III/5445/94.
2.
65/65/EEC: (OJ 022 09.02.65 p 369). D by 172 B M by 66/454/EEC (OJP 144 05.08.66 p 2658) M by 75/319/EEC (OJL 147 09.06.75 p 13) M by 83/570/EEC (OJL 332 28.11.83 p 1) M by 87/021/EEC (OJL 015 17.01.87 p 36) M by 89/341/EEC (OJL 142 25.05.89 p 11) E by 89/342/EEC (OJL 142 25.05.89 p 14) E by 89/343/EEC (OJL 132 25.05.89 p 16) M by 92/027/EEC (OJL 113 30.04.92 p 8) M by 93/039/EEC (OJL 214 24.05.93 p 22).
3.
75/319/EEC: (OJL 147 09.06.75 p 13). M by 78/420/EEC (OJL 123 11.05.78 p 26) M by 83/570/EEC (OJL 332 28.11.83 p 1) M by 89/341/EEC (OJL 142 25.05.89 p 11) D by 89/342/EEC (OJL 142 25.05.89 p 14) E by 89/342/EEC (OJL 142 25.05.89 p 14) D by 89/343/EEC (OJL 142 25.05.89 p 16) E by 89/343/EEC (OJL 142 25.05.89 p 16) M by 89/381/EEC (OJL 181 28.06.89 p 44) M by 92/027/EEC (OJL 113 30.04.92 p 8) M by 93/039/EEC (OJL 214 24.08.93 p 22).
4.
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5.
81/852/EEC: (OJL 317 06.11.81 p 16) M by 87/020/EEC (OJL 015 17.01.87 p. 34) M by 92/018/EEC (OJL 097 10.04.92 p 1) M by 93/040/EEC (OJL 214 24.08.93 p 31).
6.
87/22/EEC: (OJL 015 17.01.87 p 38) M by 93/041/EEC (OJL 214 24.08.93 p 40).
7.
Art 14.5 75/319/EEC as amended.
8.
Art. 7, 7a, 10 75/319/EEC as amended; Art 8, 8a, 18 81/851/EEC as amended.
9.
Art. 11 75/319/EEC as amended; Art. 19 81/851/EEC as amended.
10.
Art. 12 75/319/EEC as amended; Art. 20 81/851/EEC as amended.
11.
III/5445/94, p 15. REF = 894.
12.
Art. 15 75/319/EEC as amended; Art. 23 81/851/EEC as amended.
13.
Art. 15a 75/319/EEC as amended; Art. 23a 81/851/EEC as amended.
14.
Art. 15b 75/319/EEC as amended; Art. 23b 81/851/EEC as amended.
15.
Art. 13 75/319/EEC as amended; Art. 21 81/851/EEC as amended.