Principles and Practice of Pharmaceutical Medicine

in the EMEA opinion, then the decision-making
procedure is suspended, and a new opinion is
requested of the EMEA. A further Standing Com-
mittee review follows the EMEA reply. A favor-
able opinion of the Standing Committee is adopted
as a decision within 15 days and is published in the
Official Journal.
Very rarely, the Commission, being politically
and legally responsible for the approval decision,
may disagreewith the scientific opinion adopted by
the EMEA even after Standing Committee review.
In this case, the decision is submitted to the Coun-
cil. If within three months of submission the Coun-
cil has not made a decision, then the Commission
will adopt its own proposed decision.

Post-authorization provisions

Application withdrawals:Applicants withdrawing
their dossiers do so at some cost. An explanation
why the dossier is being withdrawn must be pro-
vided to the EMEA, and this information will be
published. The EMEAwill also publish assessment
reports if prepared at this time.
Expedited reviews:The new Regulation fore-
sees the possibility of an expedited procedure of
only 150 days duration, for products of major
interest for public health, which are addressing
an unmet medical need. Also, a conditional
approval may be granted, which would be
reviewed yearly.
Exclusivity:All medicines approved through the
CP will be granted an eight-year period of data
protection and a ten-year period of marketing pro-
tection (see below). This period can be extended to
11 years if, during the first 10 years, a major new
indication is developed.
Once a product has been approved through the
CP, all further regulatory activities, such as license
variations, labeling changes, new indications and
so on must be CP submissions.

Community referral

The European pharmaceutical legislation includes
mechanisms whereby a Community arbitration

may be triggered on the basis of specific articles

of Directive 2001/83, as amended. The arbitration

ends up in a binding decision, issued after a scien-

tific evaluation of the matter involved. The CHMP

is responsible for the evaluation and will endorse

the referral as admissible when the issue to be

discussed can be framed in the relevant articles of

Directive 2001/83 EC.

A referral may be started not only for a particular

medicinal product but also for a specific class of

products.Community referrals are contemplatedin

cases foreseen by the following articles of Direc-

tive 2001/83 EC:

Article 29 – mutual recognition referral:This

applies whenever a concerned MS, during a MRP,

considersthat aproductmay presentarisk topublic

health.

Article 30 – divergent decisions referral:This

article applies whenever divergent national

decisions are taken by MS concerning authoriza-

tion, suspension or withdrawal of a medicinal

product.

The procedure covers purely national MA or

MA issued following a MRP in cases, for example,

where

indications significantly diverge in different MS;

a product is suspended or withdrawn in one or

more but not all concerned MS;

a national authorization is varied, introducing a

divergence versus other national authorities.

The referral may be started by any MS, the Com-

mission or by the MAH.

Article 31 – community interest referral:This

article applies to conditions where the interest of

the Community are involved. This may especially

refer to public health issues related to a product

marketed in the EU, in the light of new data

emerged on quality, safety, efficacy or pharmacov-

igilance.

The referral may be started by MS, the Commis-

sion or the applicant/MAH.

Articles 35, 36, 37 – follow-up referrals:These

articles refer to arbitration mechanisms aimed at

resolving divergences after harmonization has

34.8 PRODUCT REGISTRATION 463