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Tuesday, 16 July 2019

EDA gets sharper teeth under newly passed legislation

LEGISLATION WATCH- EDA’s mandate expands under new pharma legislation: The Health Ministry will transfer regulatory powers over the pharma market to the Egyptian Drug Authority (EDA) under legislation passed by the House last week, the local press reported. The EDA will now be in charge of registering new products, maintaining production standards, and setting customs rates on imported products. The Prime Minister must issue the executive regulations of the legislation within six months of its announcement in the official gazette. Here’s a breakdown of the legislation:

  • The National Organization for Drug & Control Research and the Drug Planning and Policies Fund will be dissolved, with the EDA receiving the budgets and responsibilities of both organizations. Some employees will be transferred to the EDA while others will be moved to other public sector entities;
  • EDA employees will be allowed to enter facilities to supervise and inspect them if approved by the justice minister;
  • The EDA will be able to set up companies by itself or in partnership with existing companies. It will be part-funded via returns on its investments and sales, and will be exempt from paying preliminary or final insurance fees on purchases;
  • The Egyptian Authority for the Unified Procurement of Medical Supply and Technology will be in charge of making available medical products and appliances for all government entities.

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