Principles and Practice of Pharmaceutical Medicine

Good Manufacturing Practice (GMP) compli-
ance.

Research & Development (R&D) activities.

Product information.

There are no time limits for the review of company
registrations by the regulatory authorities, and long
delays are commonly experienced (up to three
years, especially in Turkey and Oman). Further-
more, the bureaucratic process is also not stream-
lined. Legalizations by the equivalent of a Notary

Public are obligatory for many certificates, confir-

mations and leaflets. Sometimes, it seems that no

piece of paper moves without a rubber stamp.

Drug registration (see Figure 36.1)

Product classification: As a first step, the relevant

Ministry of Health (MoH) classifies the new drug

into one of

Prescription only medicine (POM), for e.g. new

chemical entities or narcotics.

General process Process in Egypt, Kuwait,

UAE, Jordan and Qatar

LebanonApplication

Company

Registration

Administrative

Review

Approval

Company

Registration

Product

Classification

Review File

Laboratory

Analysis

Pricing

Application

Company

Registration

Application

Product

Product

Classification

Administrative

Review

Review File

Approval

Company

Registration

Application

Product

Laboratory

Analysis

Pricing

Approval

Product

Approval

Product

Launching

within 1–2 years

Figure 36.1 Flow chart for the company and product registration process in the Middle East. During examination of
the application, many interim responses are usual to meet the requests of the Health Ministry (MoH) concerned

36.2 COMPANY AND PRODUCT REGISTRATION 511