Sanitary Registration in El Salvador - Central America

Change to :

El Salvador Pharmaceutical Products Registration

Requirements:

Legal Services:

	Trademark Registration
	Legal Documents
	Tax Advisers
	Companies in El Salvador
	Advisory and Consultancy
	Sanitary Registration
	Labor Law and Inmigration
	Lawyers and Familiar Judgement in El Salvador
	Environmental, Energy and Communications
	Public tender, negotiations and concessions with the State
	Foreing Investment
	Offshore Partnerships

2) Samples of Reference.

12 samples of product must be submitted just as it will be sold in the market, in addition to a quantity of the pharmaceutical structure for its analysis.

The samples must indicate the following:

● Trademark and pharmaceutical structure.
● Generic name even if there are more than one chemical component.
● Lot number, manufacturing and expiration date.
● Composition of formula by unit dosage.
● The following substances must be declared if they are included in the
formulation.

- Artificial colorants
- Lanolin
- Content and alcoholic degree in ethylic alcohol.
- Additives that must be declared as per manufacturer’s judgement.

● Therapeutic indication, contraindications, dosage, special precautions if any.
● The inscription “Medicine, keep out of reach of children”.
● Way of administration.
● Registration number in the country of origin.
● Manufacturer’s name and country of origin.
● Inserted.