from the IFPMA Offices, 30 Rue du St Jean, P.O.
Box 9, 1211 Geneva 18, Switzerland.
The clinical guidelines applicable to the EC may
be obtained from the MHRA, EuroDirect Guide-
line Service, Room 1615, Market Towers, 1 Nine
Elms Lane, London SW8 5NQ, UK. Tel.:þ44 (0)
171 273 0352/0228.
Mutual recognition of established
products and line extensions
The bulk of national licensing activities relates to
new formulations of older products, generics and
line extensions. However, over the years, the
indications, contraindications, warnings, dosages
and so on of even well-known products differ
significantly from member state to member
state. The national reviews required of older
products that were conducted by each member
state of the EC were not accompanied by any
international concentration of effort and did not
lead to harmonization within the EC. This has
made it difficult for companies to use the mutual
recognition procedure for the introduction of
generic products, as the summary of product
characteristics (SPC) differs between member
states. The same problem can affect the origina-
tor of an established chemical entity when the
company wishes to introduce a line extension,
because even under the operation of the mutual
recognition procedure, where the CPMP opinion
was not binding, there were differences in
dosages, indications, contraindications and warn-
ings between member states.
In 1996, the Swedish government proposed a
solution to the impasse affecting the use of the
mutual recognition procedure for generic pro-
ducts. This would have allowed generic compa-
nies to apply for recognition only of the quality
and bioequivalence data, the rest of authorization
to market, that is indications, contraindications
and warnings, would be decided by the national
authorities, bearing in mind these factors as they
applied to the originator’s product in each
member state.
In April 1997, the EC Commission announced
that, rather than change the Directives to allow
the ‘core SPC idea’ as advanced by Sweden, it
would ‘reinterpret’ them. In practice, this means
that generic companies would, from 1 January
1998, be able to use the mutual recognition pro-
cedure only when the originator’s SPC was iden-
tical in all member states, that is the originator’s
product had mutual recognition status or a cen-
tralized license. In practice, this means that gen-
erics will have to use national procedures ‘which
were due to be phased out on 31 December
1997’. Line extensions of existing products,
that is new dosage forms and so on, would logi-
cally be caught in the same net as generics if the
initial product did not have an identical SPC in
all member states. Currently, some companies
are withdrawing products from the market and
replacing them with a new salt of the same active
substance in an attempt to thwart generic pro-
ducts entering the market.Changes ahead for European regulation?
Possible changes to the centralized procedureIn view of the increased membership of the EU,
in future years, if standards of granting MAs for
medicines are not to decline, measures will have
to be taken to preserve the standards that oper-
ated in Northern Europe prior to 1994. It could be
conceded that all NCEs should be handled
through the centralized procedure. This could
only be acceptable in terms of consumer safety
if the competence of advice available to the
EMEA was increased. EMEA staff themselves
must be technically competent to do the assess-
ment work currently done by those national drug
regulatory authorities, appointed to act on behalf
of the rapporteur and co-rapporteur. The use of
national drug regulatory authorities to do the
work of rapporteur and co-rapporteur would
cease. The staff recruited to the EMEA to do
this expert work should be recruited on the
basis of quality, rather than having regard to the
adherence of ‘national quotas’ of staff. The
CPMP, currently composed of one member
from each of the 25 member state’s regulatory
authority, should be disbanded. The technical33.4 THE EUROPEAN CONTROLS OF MEDICINAL PRODUCTS 439