ARCSA registration for foreign medicines in Ecuador
To sell a medicine in Ecuador you need a sanitary registration from ARCSA, the national regulator, filed by a local company. Global Medical Services takes that role for foreign laboratories.
What ARCSA requires
Documents from the title holder, apostilled and translated into Spanish.
- Letter of authorizationThe title holder names the Ecuadorian company as local applicant. It does not need to be exclusive.
- Certificate of Pharmaceutical Product (CPP)WHO format, issued by the authority of the country of origin.
- GMP certificateFor the manufacturing site.
- Technical dossierQuality, stability, labels and package insert.
Homologation: the fast track
If the product is already approved by a high-surveillance authority such as the US FDA or the EMA, ARCSA registers it by homologation, with a much shorter dossier.
A registration lasts 5 years and covers one strength: warfarin 5 mg and 1 mg, for example, are two separate registrations.
Reference fees
Per product and strength, as of October 2026. Confirm the current fee with ARCSA.
| Product type | Fee |
|---|---|
| Foreign medicine by homologation | USD 2,258.41 |
| Generic medicine | USD 565.21 |
| Generic on the National Essential List | USD 452.17 |
What we do
- Local applicantWe file with ARCSA.
- ImportShipping and customs.
- StorageA partner's licensed warehouse in Quito.
- DistributionHospitals, clinics and pharmacies nationwide.
Frequently asked questions
Can a foreign laboratory register directly in Ecuador?
No. ARCSA requires an applicant domiciled in Ecuador, acting with the title holder's letter of authorization.
Do I need an exclusive distribution agreement?
No. ARCSA only requires the letter of authorization. Exclusivity is a commercial term negotiated separately.
How long is a sanitary registration valid?
Five years, then it is renewed.
Does each strength need its own registration?
Yes. Each strength and dosage form is a separate registration.