well respected, the very form of the notarization can
cause concern. For example, Jordan only accepts
documents from the German regulatory authority
(BfArM) when they bear the old-fashioned rubber
stamp with its image of an eagle. Personal contacts
and people with deep local experience become
mandatory under such conditions.
Pricing
For pricing, the classification is necessary to deter-
mine if the product fits into a category that needs
price fixation, or not. Normally, for all prescription
products and some OTC products, a price fixation
is obligatory. For OTC products, it depends on the
active substance and the indications mentioned for
the product itself. No price fixation is necessary for
productsthat are herbals and food supplements, nor
for cosmetics.
For pricing, the process starts by submitting a
legalized certificate for the specific product with
the following information on it:
Name of the manufacturer or marketing author-
ization holder.
Name and address of the local partner.
Wholesale price in the country of origin.
Registered price in neighbor countries (if
available).
Suggested CIF in the specific country.
Such a certificate has to be signed by the manufac-
turer and must be legalized by the Chamber of
Commerce and the Embassy of the concerned
country. Innovative products will generally receive
a price that is higher than for a follow-on product
with the same, or similar, active ingredient. Gen-
erics must accept a lower price. The basis for price
finding is always evolving, and an average price,
using the three lowest prices from the region itself,
is a recent development.
The time needed to obtain a price is usually
about months, depending on the MoH.
Saudi Arabia has a separate pricing committee,
which considers ex-factory wholesale price, public
price in the source country, export price to Saudi
Arabia, and export price of some 30 other countries.
Normally,the lowestprice found willthen be awarded.Tender
Governmental companies or institutions, for exam-
ple, army or hospitals, offer tender business
throughout the Middle East, on anad hocor annual
basis. It is even possible that unregistered products
can be tendered for, especially when serious dis-
eases or the need of huge amounts of medicines
exist. Every company can apply for a tender; the
government will choose the most appropriate one,
depending on quality and price.The GCC-DR
The member states are as follows:Saudi ArabiaKuwaitUAEOmanBahrainQatarThe executive office for the health ministers is
located in Riyadh, Saudi Arabia. The committee
consists of a chairman, two members of each of the
six member states and a secretariat. The responsi-
bilities of GCC-DR are as follows:Registration of pharmaceutical companies.Registration of pharmaceutical products.Inspection of pharmaceutical companies con-
cerning GMP compliance.514 CH36 DRUG REGISTRATION AND PRICING IN THE MIDDLE EAST