entitles the sponsor to the above listed incentives
for development of the drug.
Sponsors need to notify the EMEA of the intent
to file an application for orphan designation. A pre-
submission meeting with COMP will be arranged,
if viewed as desirable. The submission is usually
validated within 10 days of receipt, and then
COMP will assess the submission within a further
60–90 days. When the COMP has adopted an
opinion, it is send to the European Commission,
whose binding decision is issued within a further
30 days. Orphan drug designations are published in
the Official Register on the EMEA web site, after
applicants have had the opportunity to review a
draft and redact proprietary information.
34.10 Generic medicinal products
Directive 2004/27 provides the following defini-
tion of generic medicinal product (Article 10,
- (b)): ‘generic medicinal product shall mean a
medicinal product which has the same qualitative
and quantitative composition in active substances
and the same pharmaceutical form as the reference
pharmaceutical product, and whose bioequiva-
lence with the reference medicinal product has
been demonstrated’. As a result of various recent
treaties, Europe, like the rest of the world, recog-
nizes patent protection on all new inventions for
20 years after the patent application is filed. How-
ever, in the special case of medicinal products,
where the long development cycle allows a product
into the market only late in the life of the patent, a
supplementary patent protection for a maximum of
five years can be applied for, under certain circum-
stances. Although detailed discussion of European
patent law is outside the scope of this chapter, we
shall adopt a general definition for a ‘generic drug’
as one that is approved as a bioequivalent product
after the innovator’s patent has expired.
Nomenclature
Dossiers for generic products must be as complete
for all quality and manufacturing aspects as any
innovator product. However, a generic drug dossier
can merely reference an innovator’s dossier for
data concerning product safety and efficacy. For
this reason the application for a generic product is
also known as an ‘abridged’ application.
The innovator’s product is termed a ‘reference
medicinal product’ for the same reason. This is a
product that has a legally valid MA in a (some) MS,
which was granted on the basis of a full-length
dossier.
Application to market a generic medicinal pro-
duct can be made in one MS even when the refer-
ence product is only authorized in a different MS.
In this case, the MS in which the reference product
is marketed can be askedto transfer a copy ofall the
relevant documents by the MS holding the generic
application. There is a one-month deadline for this.
Quite apart from patent protections, innovator
products are granted eight years of data protection
and ten years of market exclusivity (see above),
plus a further year of market exclusivity if a major
new indication is registered. This means that a
generic medicinal product can be placed on the
market only 10 (or 11) years after the original
authorization, although experimental activities to
prepare the dossier, in particular to conduct bioe-
quivalence studies, can start two or three years
earlier.
FollowingtheCTD format,a generic application
must contain Module I (administrative informa-
tion), Module II (overviews and summaries) and
Module III (quality). Bioequivalence data, as they
refer to clinical experimentation, are submitted in a
separate binder, following the numbering system
of Module V (Section 5.3.1.2).Drug substance
Different salts, esters, ethers, and derivatives of the
same active moiety from acceptable generic pro-
ducts, are permitted provided that they have the
same characteristics of safety and efficacy. Proof of
absence of significant differences must be supplied
by the applicant through appropriate studies, the
extent and content of which has to be decided on a
case-by-case basis.
The use of different synthetic pathways by dif-
ferent manufacturers may also be acceptable. It is466 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION