Localization
Youssry Saleh Law Firm / Egypt
The key facts about the localization in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
Yes, the legal framework of localization is regulated through Ministerial Decree No. 425 of the year 2015 and Ministerial Decree No. 820 of the year 2016.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
No, there have not been any significant changes involving localization rules.
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, in Egypt, the marketing authorization process is not affected by localization polices.
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, the pricing process of pharmaceuticals is not impacted by localization policies. The pricing mechanism in Egypt is regulated through Ministerial Decrees No.314 of the year 1991, Decree No.373 of the year 2009 and Decree No. 499 of the year 2012. Egypt adopted pricing method of cost plus margin, which means that each company submits a study reflecting the cost for producing or importing pharmaceuticals in to the market and automatically apply the applicable margin for each stakeholder in the supply chain up the customer price. After issuing decree No. 373 of the year 2009 Egypt adopted a new pricing method based as it applies the least customer price available in any country where the pharmaceuticals is traded after applying a discount 10% , the same margins for distributor and pharmacist remains applicable even after the issuance of this decree.
Under decree No. 499 of the year 2012, the decree aimed to increase the margins for distributors and pharmacists, while maintain the same pricing method with slight variations.
Mainly, the prices of the pharmaceuticals are determined during the registrations phase, the pricing committee in the Central Administration of Pharmaceutical Affairs CAPA is responsible for reviewing the pricing application and documents.
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, the reimbursement policy is not impacted by localization policies.
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No, the access to public tenders of pharmaceutical products is not impacted by localization policies in Egypt.
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?
Neither Import tariffs, importation nor exportation permits nor taxation of pharmaceutical products are impacted by localization policies in Egypt.
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
The ministry of health “MOH” has adopted the Common Technical Document (CTD) system, which supports the Egyptian pharmaceutical companies to register their products and benefit from a number of incentives pertinent to pricing and supply of alternatives.
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
Currently, there have not been any discussions regarding implementing any new localization policies in Egypt, other than the rules, which are declared in the Ministerial Decree No. 425 of the year 2015, and Decree No. 820 of the year 2016.
