What counts as a medicine recognized by law
The Medicines Law No. 1737 (article 4) includes generic and brand-name medicines, official preparations, magistral formulas, homeopathic medicines, products of plant, animal or mineral origin with medicinal properties, and special medicines, biologicals, blood derivatives, dietary products, dental products, cosmetics, radiopharmaceuticals, medical devices, diagnostic substances and clinical laboratory reagents.
Why the company must be registered
AGEMED reminds that laboratories, importers and distributors must hold the Administrative Resolution of operation issued by AGEMED and comply with Good Storage and Manufacturing Practices as applicable.
There are different opening forms depending on what is imported: medicines recognized by law, cosmetics, medical devices, hygiene products, diagnostic reagents or raw materials.
How the procedure unfolds
Since Circular 12/2024 there is no prior in-person review. The numbered physical file is submitted at Window 3. The Surveillance and Control Department assesses whether the file complies or not.
If it complies, the payment order is issued and the procedure continues. If it does not, the file is returned to correct the observations and is submitted again.
After opening
Licensed companies renew every year and keep their company certificate up to date. To market each product, its health registration is also needed (see the health registration guide).
Sources
- Medicines Law No. 1737, art. 4 (cited in CR-23-2023 and in form FORM-092)
- CR-23-2023: Reminder of national and supranational rules on cosmetics and household hygiene
- CR-12-2024: Document review for operating-license procedures
- Opening forms FORM-092 to FORM-097 and FORM-107 (annual renewal)
- RM-0909-2005, item 2.2.2 (valid company certificate)
General information. Requirements are subject to the current AGEMED regulations.