Egypt is one of the largest markets in the Middle East, with 25% market share. The market is estimated at USD $700M with an average growth of 7.1% per annum.
Egypt is facing nutritional challenges mainly due to low income, high food prices, low local agricultural production, and poor dietary practices. Due to low enforcement of existing laws, there are also problems with environmental pollution and food safety. During the last few years the Ministry of Health and Population in Egypt has placed nutrition as one of its main priorities and have developed a 10-year Food and Nutrition Policy and Strategy (2007–2017).
In Egypt, a dietary supplement is not considered a drug or an alternative for food, and is not used alone to treat, diagnose or prevent diseases. The Egyptian Drug Authority is responsible for overseeing the registration of dietary supplements. The Egyptian Drug Authority (EDA) is responsible for protecting the population’s health by regulating the safety and quality of medicines (human and veterinary), biologicals, medical devices, cosmetics, dietary supplements and pesticides. The EDA has three sub-organizations, CAPA, NODCAR & NORCB.
CAPA (Central Pharmacy Administration) is a regulatory body that includes 4 Services which are Registration, Licensing, inspection and import/export. All importers of dietary supplements must apply for a licence. The validity period of the licence varies from one to 5 years depending on the product.
One of the unique challenges facing foreign suppliers of marketed health products in Egypt is the mandatory pricing imposed by government. In other words, if there are comparable products already on the market in Egypt, any new comparable product would be subject to mandatory pricing to keep it competitive. More than this, there is a very strong incentive for Egyptian manufacturers over imported products. This means that exporting a Canadian-made product to Egypt may not be possible, and the product may need to be manufactured in Egypt (using “toll manufacturers”). Also, government regulatory fees are around $3,000 USD per product, not including regulatory consulting fees such as through our company.
NHP Consulting has expertise in Dubai and the surrounding region, providing regulatory and business development services to the region. Contact us to learn more about how we can help.