Сближаване на законодателствата

1. In considering a marketing authorisation for a new product (C) under [point 8(a)(iii)], referencing a product (A) authorised more than 6/10 years ago, is a national competent authority ever entitled to cross-refer, without consent, to data submitted in support of a product (B) which was authorised within the last 6/10 years?
2. If so, may such cross reference be made in circumstances where:
(a) product B was authorised under the [point 8(a)] hybrid abridged procedure, referencing product A; and
(b) the data to which reference is made consists of clinical trials which the national competent authority indicated would be necessary if the marketing authorisation was to be granted and which were submitted in order to demonstrate that product B, though supra-bioavailable to product A when administered in the same dose, is safe?
3.(a) Does the final subparagraph of [point 8(a)] (“the proviso”) apply only to applications made under [point 8(a)(iii)] or to applications made under point [8(a)(i)] also?
(b) Is essential similarity a prerequisite for the use of the proviso?
4. Can products ever be essentially similar for the purposes of [points 8(a)(i) and (iii)] when they are not bioequivalent, and if so in what circumstances?
5. What is the meaning of the term pharmaceutical form, as used by the Court in its judgment in Case C-368/96 Generics
In particular, do two products have the same pharmaceutical form when they are administered to the patient in the form of a solution diluted to a macro-emulsion, micro-emulsion and nano-dispersion respectively?
6. Is it consistent with the general principle of non-discrimination for a national competent authority, faced with hybrid applications for marketing authorisations under point 8(a) referencing product A for two other products, neither of which is bioequivalent to product A:
(i) to indicate that it is necessary for a marketing authorisation to be granted for product B to be supported by full clinical data of the type required by Part 4(F) of the Annex to Directive 75/318/EEC; but
(ii) having considered the data filed in support of product B, to grant a marketing authorisation for product C if that application is supported by trials not meeting the requirements of Part 4(F) of the Annex to Directive 75/318/EEC …?