How much does an application for authorization to market a medicine in Tunisia cost? An order from the Minister of Health, dated November 13, 2026 and published in the JORT No. 110, sets the fees payable to the National Agency for Medicines and Health Products. The amount depends on the medicine, its origin and the filed dossier.
This new tariff schedule is mainly aimed at manufacturers, laboratories, importers and other professionals. It does not set the prices of medicines sold to patients in pharmacies: it concerns administrative, technical and regulatory services.
The essentials
For an ordinary initial marketing authorization application (AMM), the fee is 18,000 DT for an imported reference medicine, 14,000 DT for an imported generic and 12,000 DT for a local generic, per specialty. An abbreviated or verification procedure may reach 25,000 DT. Renewals, checks and inspections have their own fees.
Base tariffs for medicines intended for humans
Here are the seven categories listed in the annex for an initial ordinary AMM application. The amounts are expressed in Tunisian dinars and billed per pharmaceutical specialty, not per box or per patient.
| Product type | Origin | Tariff (DT) |
| Reference | Imported | 18,000 |
| Biological / biosimilar | Imported | 16,000 |
| Generic | Imported | 14,000 |
| Reference | Local | 16,000 |
| Biological / biosimilar | Local | 12,000 |
| Generic | Local | 12,000 |
| Medical gases | — | 12,000 |
Fees for ordinary initial AMM requests, per specialty. JORT No. 110, p. 2670.
The grid distinguishes notably reference medicines, generics, biologics and biosimilars, as well as medical gases. Therefore, you should not automatically apply the tariff of one category to another.
Another procedure may cost 20,000, 22,000 or 25,000 dinars
The JORT also sets the fees for authorization requests under the abbreviated or verification procedure: 25 000 DT for a reference medicine, 22 000 DT for a biologic or biosimilar, and 20 000 DT for a generic. This is a separate procedure from the ordinary request, not a supplementary amount automatically added to the table’s totals.
Other amounts concern additional dosages of the same specialty. In the context of the ordinary application, they reach notably 9 000 DT for an imported reference medicine, 7 000 DT for an imported generic and 6 000 DT for a locally manufactured generic.
Renewals: why the filing date matters
A renewal application filed before the AMM expires and the same application submitted after the expiry are not charged in the same way. For an imported reference medicine, the scale indicates 6,000 DT before expiry and 12,000 DT after expiry. For a local generic, the rate rises from 3,000 to 6,000 DT.
These examples show that anticipating renewal can have a real financial effect for the operator. The text also provides specific fees for minor or major modifications of authorizations, transfers and certain appeal requests.
Veterinary medicines: a different grid
For an initial veterinary AMM application, the annex provides 11,200 DT for an imported reference medicine, 9,500 DT for an imported biologic and 8,000 DT for an imported generic. The amounts are 9,000 DT for a local reference medicine, 7,000 DT for a local biologic and 6,000 DT for a local generic. These amounts should not be confused with those for human medicines.
Medical devices, cosmetics, inspections: other fees
Preliminary technical opinions prior to market entry include, for example, 150 DT per item for certain medical devices, dietary supplements or cosmetic products; 500 DT for technical support equipment and 2,000 DT for diagnostic equipment. Physico-chemical or microbiological analyses, when required, are priced separately.
Periodic inspections of good manufacturing practices are priced at 5,000 DT for the three-year interval stated by the JORT. Periodic inspections of good distribution practices are, themselves, priced at 1,000 DT. The filing of a new industrial-scale international clinical trial dossier is listed at 10,000 DT in the corresponding category.
These amounts constitute a selection of useful services to know, and not an exhaustive reproduction of the grid: the annexes also cover certificates, manufacturing, import, export, technical controls and scientific information.
What documents to provide and who should pay?
According to Articles 2 and 3, the service essentially requires the submission of an administrative and technical file and proof of payment of the fee corresponding to the request. An exception is expressly provided for inspections of good manufacturing and distribution practices. The specifications and procedure guides are prepared by the Agency and published on its official portal.
For certain authorizations of imported medicines — obtaining, transfer or renewal —, Article 4 provides for the collection of the equivalent value in convertible foreign currencies. The order repeals contrary prior provisions, notably two texts from September 8, 2011. It does not, by itself, allow calculating an increase compared to the old tariffs without comparing the corresponding categories and procedures.
What to keep in mind before paying
For a professional file, successively verify the product type, its origin, the nature of the request, the billing unit and, if it concerns a renewal, the expiry date. For patients, these fees are neither the public price displayed by the pharmacy nor the amount reimbursed by CNAM.
Main source : JORT No. 110 of 13 November 2026, Arabic edition transmitted to Tunisie Numérique, pages 2669 to 2679 (order and annexes). See also the regulatory text in French.
