Pharmacy only, and there are differences (with
sub-classes for over-the-counter (OTC) products
and herbal medicines.
Food supplements or cosmetics.
The regulatory application requirements are diff-
erent for each category, with most needed POM
products, and least for food supplements or
cosmetics.
General requirements for product
registration
Documentation for submission
A country-specific application form.
Certificate of a Pharmaceutical Product (CPP)
according to the format issued by the World
Health Organization (WHO).
Dossier with administrative data, pharmaceuti-
cal, pharmacological–toxicological and clinical
documentation.
The dossier should include the following:- Documentation similar to that specified in the
Notice To Applicants (NTA). - Stability data (which are probably more strin-
gent than elsewhere in the world); three
batches must be tested at three different
temperatures/humidities for the complete
shelf life: 25C/60%RH and 30C/70%RH.
Additionally, six months, 40C/75% RH must
be studied. - Specific documentation with regard to phar-
maceuticals containing alcohol, which usually
have the most difficulty during the registration
process (especially in Saudi Arabia). Special
declarations, confirmations and statements of
interest are necessary to convince authorities
which prefer the traditional absolute ban on
alcohol.- Expert reports on pharmaceutical, pharmaco-
logical–toxicological and clinical data. - Supporting literature from any source.
- Expert reports on pharmaceutical, pharmaco-
Price certificate, which is country specific,
sometimes in three forms, Cost Insurance
Freight (CIF) price, wholesale price, retail price.Finished product samples with Certificate of
Analysis (CoA).Packaging (leaflet has to be part of the CPP for
some countries, e.g. Jordan, Israel).Reference substances with CoA.Pricing
Pricing is part of the registration process, and in
some countries,pricing is strictlytied to someother
parameter, for example, the lowest price in Europe
or elsewhere in the Middle East region (see also
Appendix).Product launch
After approval, the registered product must be
launched within a certain time period – usually
one to two years. At the time of launch, in most
countries, the product supply must meet a defini-
tion of ‘fresh’, that is, that at least two-thirds of the
product’s shelf life must be remaining. Usually, the
product must also be registered and sold in the
country of origin. It should have the same trade
name, composition, shelf life (confirmation often
required as an attachment to CPP, e.g. UAE) and
leaflet. Exceptions are possible; often it depends on
good contact with the partner in the country.Labeling
The package insert must be like the leaflet of the
country of origin, pending an officially approved
translation in some countries (Saudi Arabia, UAE,512 CH36 DRUG REGISTRATION AND PRICING IN THE MIDDLE EAST