Drug Evaluation & Registration Department
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FREQUENTLY ASKED QUESTIONS (FAQ)

1. How can I apply for registration?

Answer: After collecting the registration guideline compile the required data according to the guideline and submit your application accompanied with evidence of registration fee.

2. Is registration required for drugs locally manufactured or drugs that are going to be imported into the country?

Answer: Yes, any drug, be it manufactured locally or imported in to the country as a finished product by private, government, non-government or donors needs registration.

3. Who should have to apply for registration?

Answer: The actual manufacturer of the product should compile the information required for registration. The application for registration can be submitted, by a person or organization assigned by the manufacturer. One manufacturer can have only on local agent in the country.

4. How can I know the registration status of my application once I have submitted the dossier for registration?

Answer: After 15-21 days of submission of the dossier the local agent can collect the written evaluation report from the Drug Evaluation and Registration Division.

5. How long will it take for registration of an Abbreviated New Drug?

Answer: If the dossier is compiled according to the registration guideline an average of 3-4 month is needed for registration of abbreviated new drug (drug which is registered or marketed in the country previously).

6. How long will it take for registration of a New Drug?

Answer: An average of 4-6 month is required for registration of a New Drug if all the information is compiled according to the guideline (drug which is new to the country or world market).

7. Is registration fee required?

Answer: Yes, registration fee is a must for all products and in fact evidence for the fee should be submitted at the time of dossier submission.

8. Is submission of actual product required during the submission of registration dossier?

Answer: No, actual product submission is not required during submission of the dossier. It will be requested in writing later after the approval of the dossier by the authority.

9. Which pharmaceutical products require registration?

Answer:

a) Human drugs

b) Veterinary drugs

c) Cosmetics

d) Medical devices

e) Traditional medicines

f) Pesticides (

10. Is there any demarcation for application?

Answer: Yes, if the drug is included in to the National Drug List, the applicants can apply for any of the drug in the list. However, if the drug is not included in the list, first the applicant should have to submit clinical data for the safety and efficacy of the drug following drug inclusion format. If the submitted clinical data shows that the new drug is advantageous over the existing drug in the list, the drug will be included in to the list and normal registration proceeds.

11. What is the validity period of registration certificate?

Answer: Registration certificate (i.e. Marketing Authorization) is is valid for five years.

12. When is re-registration required for products already registered?

Answer: Re-registration is required after five years from the date of issue of the certificate.

13. Do I have to notify the Authority if any variation is made to a product?

Answer: Yes, any variation, whether it is major or minor variation should be reported to the Authority and the type of variation and the type of data indicated in the guideline should be submitted and amended before trying to market the product.

14. With which product or drug should I have to make my bio-equivalence comparison?

Answer: With innovative products or market leading products that are already registered in Ethiopia.