For the importation, distribution, commercialization, prescription and promotion, all medicines previously require their sanitary registration before the regulatory authority, for which the following aspects must be considered:
If a product is manufactured in more than one country, a sanitary registration must be processed for each country or manufacturing laboratory.
For products to be marketed with a brand and generic name, an individual Sanitary Registry will be granted and processed separately.
All certificates or official documents required must be valid at the time of presentation. Official documents that do not have a declared validity period will be valid for two years from the date of issue.
If the Certificate of Free Sale does not include the expiration date, it will be valid for two years from the date of issue as long as the sanitary registration of the product is valid in the country of origin, in accordance with the declared in the document.
Corrections in the certifications or in the official documents presented are not allowed, unless they are supported by the same body that issued the original document.
All official or legal documents issued abroad must comply with the provisions of Article 37 of the Law of the Judicial Organism.
The name of the drug to be registered must not cause confusion with another already registered, either in its written or pronounced form, therefore the name of the drug to be registered must meet the following conditions:
The registration of medicines with the same brand name and different active ingredients is not allowed, nor is the use of a brand name that has been previously used for products with different indications accepted.
Registration is only accepted using the same brand name, in the case of medicines declared over-the-counter that are used with similar therapeutic indications, even if they contain different active ingredients (treatment lines).
The registration of over-the-counter pharmaceutical products with several active ingredients is accepted, using them as part of the name of a therapeutic action.
When the name of the product is generic, it must be accompanied by the name of the owner of the product.
The name of the drug, the logos or other phrases should not have therapeutic connotations that could lead to confusion in the indications for use.
The name of the drug to be registered must coincide with all the documentation presented, otherwise, an explanatory note must be submitted signed by the responsible pharmaceutical professional, owner or his legal representative if authorized to do so, specifying that all the documents correspond to the same drug.
A pharmaceutical product may be designated by either a trademark name or an International Nonproprietary Name. When it is a trademark, it cannot be confused with an international nonproprietary name or mislead about its therapeutic properties or its nature.
The presentations of the pharmaceutical products must be in accordance with the treatment scheme. Larger presentations must indicate "Hospital use" on the packaging. In the case of office products, presentations will only be accepted in their final packaging for direct sale to the public.
The marketing of medical prescription products in dispenser boxes will be accepted, provided that all the information contained in secondary packaging with legible font size can be included in its final packaging for sale to the public.
To register products in associations with fixed doses, you must take into account the list of associations with fixed doses not allowed issued by the Department.
All documents attached to the file must come in Spanish or with their respective sworn translation, in the case of documents from abroad, they must comply with the provisions of Article 37 of the Law of the Judicial Organism.
