medical BLOG | DATE- 2022-12-27

HOW TO OPEN PHARMACY IN ETHIOPIA

A pharmacy is a shop or hospital dispensary where medicinal drugs are prepared or sold. Ethiopia is one of the countries in which a license in required to practice and open pharmacy. An applicant must be qualified by graduation from a recognized college of pharmacy, meet specific requirements for experience, and pass an examination conducted by a board of pharmacy appointed by the government.

On planning to open a pharmacy in Ethiopia one comes across with Ethiopian Food and Drug Administration (EFDA).

What’s EFDA?

The Ethiopian Food and Drug Administration (EFDA) oversees the market authorization and import permit approval for both medical and food products for a wide variety of vendors from multiple countries using the Electronic Regulatory Information System (eRIS). Fully online, both applicants and EFDA use eRIS to manage the licensing, registration, and import application process using this shared portal. This has dramatically increased processing efficiency and transparency and facilitated one unbroken chain of information – from application to port.

How the eRIS system works?

  1. i-License: is an open source, online application developed for the Ethiopian Food and Drug Administration (EFDA) which allows importers, exporters, wholesalers and manufacturers to apply for certificate of competency and for EFDA authorities to approve these applications online.
  2. i-Inspect: is a web-based application that allows EFDA to inspect importers, exporters, wholesalers, and manufacturers online using ODK collect as a supporting application to fill checklists offline and upload to i-Inspect and also i-License. It also helps manufacturers to request cGMP inspection applications online. EFDA utilizes i-Inspect as a tool to speed up the inspection process.
  3. i-Register: is an open source, online application developed for the Ethiopian Food and Drug Administration (EFDA) which allows importers to apply for market authorization approval to register products in Ethiopia for import and for EFDA staff to review and approve these applications online.
  4. i-Import: is an open source, online application developed for the Ethiopian Food and Drug Administration (EFDA) which allows importers to apply for and receive permits to import medicines & Medical device products online and EFDA staff to manage these applications online.

         5. i-Clearance: is an open-source, an online application developed for the EFDA which allows importers to apply pre-shipment document review & Physical assessment through eSW and receive                document verification & port release for medicines and medical devices online.

One has to go through those steps and application forms online through the portal.

Check list for opening a pharmacy in Ethiopia

Having the above requirements, you now can apply for EFDA (Ethiopian Food and Drug Authority) on the above system mentioned.

Budget needed

It can be categorized into two.

  1. Startup costs including:

       2. Running costs including:

Summarized steps

  1. Make sure to have all the requirements on the check list
  2. Pay for the application
  3. Apply to i-License using the following address - CLICK HERE
  1. After you apply, you will be called you within a week to check all the filled pieces of information are correct.
  2. Your place will be inspected.
  3. If the inspection was a success then a certificate of competence will be given.
  4. Then your good to go to get your license.

YOU CAN SEE THE LIST OF MEDICINES HERE

 

For more information contact the EFDA through the following address:

Place – Africa Avenue, near wolosefer, Kirkos sub city, 02/03 kebelle, 02

Phone number – +251-11-552-41-22

Website – CLICK HERE

Contact page –CLICK HERE

Email – regulatory@fmhaca.gov.et

 

WRITTEN BY - Bezawit Girma-Med In Ethiopia Team

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WRITTEN BY - Bezawit Girma

Med In Ethiopia Team

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