Updates on Authorization Fees in Algeria
11/06/2020
SAARPE Association / Algeria
Drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law in Algeria. Fees are payable by the person who makes the application or submits variations, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones.
The supplementary Finance Law for 2020 has just been published in the Official Gazette. Its Article 61 has modified authorization fee due for a new application related to imported and non-essential drugs and biologics.
As at June 2020, the current authorization fees are:
- For each new application related to imported and non essential drug or biological: 2.000.000 to 20.000.000 DZD (approx. 16.700 to 167.000 USD);
- For each new application related to imported and essential drug or biological: 600.000 DZD (approx. 5.000 USD)
- For each new application related to locally-manufactured and non essential drug or biological: 150.000 DZD (approx. 1.250 USD);
- For each new application related to locally manufactured and essential drug or biological: 100.000 DZD (approx. 835 USD)
- For each new application related to imported medical device: 300.000 DZD (approx. 2.500 USD);
- For each new application related to locally-manufactured medical device: 150.000 DZD (approx. 1.250 USD);
- For each product assessed: 30.000 DZD (approx. 250 USD);
- For each API batch controlled in laboratory: 15.000 DZD (approx. 125 USD);
- For each finished product batch controlled in laboratory: 12.000 DZD (approx. 100 USD);
- For each market authorization renewal application: 300.000 DZD (approx. 2.500 USD);
- For each variation(s) submission: 150.000 DZD (approx. 1.250 USD);
- For each application related to clinical trial authorization: 300.000 DZD (approx. 2.500 USD).
