Jordan and Oman). Otherwise, the language can be
English and/or Arabic. Nonetheless, inadvertent
offencemustbe avoidedinthese religious countries.
Objections to labeling can come from unexpected
quarters in a region where there are cultural obsta-
cles to the use of terms such as ‘naturally powerful’
or ‘uses the knowledge of nature’ in advertising,
which will not be acceptable in Saudi Arabia and
some other countries because of an underlying pre-
sumption within the concept that only Allah is all
knowing, and therefore that only Allah is powerful.
Line extensions
Line extensions, for example, an alternative route
of administration, are approved with similar
requirements for documentation to primary appli-
cations for new chemical entities.
36.3 Summary
The Middle East is a complicated region for the
inexperienced regulatory affairs officer. A local
affiliate, who will act as an intelligent professional
partner and can manage the product registration
details with the Ministries of Health, is a major
advantage for doing business in this region. Busi-
ness plans and financial models must anticipate the
possibility of long approval times, and direct con-
tact between applicant and regulatory authority, or
between Ministry and Marketing Authorization
Holder (MAH) is unlikely. Lastly, during Ramadan
(currently mid-October to mid-November in the
European calendar), most regulators’ offices, phar-
maceutical companies and distribution channels
operate with minimal activity.
Appendix: application process
New application
This requires classification as to prescription-only,
and so on.
‘Variation’
The documentation depends on the kind of change:Change Requirements
Composition CPP, updated documents,
stability, samples
Shelf life CPP, stability data, samples
Leaflet CPP, updated leaflet
Pack size CPP, stability data, samples
Price Price certificate
Analytical methods Updated pharmaceutical
documentsCPP: Certificate of a Pharmaceutical Product.Renewal
Most countries have a re-registration system.
Approvals are valid for five years. Three to six
months before the expiration date of the marketing
authorization, an updated file must be submitted. In
some countries, it is sufficient to submit only a new
CPP, such as in Lebanon.Certification/legalization procedures
As mentioned in Section 36.2 of the chapter, lega-
lizations or notarizations play a major role in the
registration process in Middle East countries. Even
if, as a premise, a relationship based on trust and
honor exists between the authority, partner and
applicant, Ministries will still insist on several
confirmations, certifications, declarations and so
on, additional legalization may also be required
from the Embassy of country of the product’s
origin. A common request for a declaration is to
give a statement that the product does not contain
any substances from animal sources (especially
pork) or that products are alcohol free.
Difficulties also arise in unexpected quarters.
Regulatory authorities may have a particular respect
or regard for some forms of notarization and not
others. Thus, the identity of the notarizing entity
can count for as much as the notarization itself.
Furthermore, even when the notarizing entity isAPPENDIX: APPLICATION PROCESS 513