HOW TO OPEN PHARMACY IN ETHIOPIA

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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.
  • Importers, Government Institutions, UN Agency, NGOs, etc. request import permits through Single Window and i-Import will approve the requested import permits automatically.
  • This will update the Importers, Government Institutions, UN Agency, NGOs, etc. of the status of their requested application status throughout the approval process.

         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.

  • Pre-shipment: is a process which will allow traders to request for pre-shipment document verification through ESW and get document verification approval from EFDA through i-clearance one of eRIS module.
  • Physical Assessment (Port Clearance): is a process with will allow traders to request the actual release of the products once they are delivered to the ports from the supplier/ license holders trough eSW and EFDA will process the review and generate release permit of the products through eRIS i-Clearance module.

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

Check list for opening a pharmacy in Ethiopia

  • A good plan
  • A good place
  • Startup budget
  • Professionals required:
    • A technical manager – One pharmacist who has at least 3 years of job experience.
    • A store manager – One druggist who has at least 2 years of job experience.
  • A TIN

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:
  • Cost to rent or buy a place.
  • Cost of furniture

2. Running costs including:

  • Inventory cost to maintain a supply of medication and cosmetics. Click here to know the list of medication a pharmacy should supply.
  • Staff cost

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
    • First, create an account
    • Login to the account
    • Fill in the required application form

4. After you apply, you will be called you within a week to check all the filled pieces of information are correct.

5. Your place will be inspected.

6. If the inspection was a success then a certificate of competence will be given.

7. 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

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