1) An application is filed before the Board of Public Health, along with the following data:
1.1 Personal data of applicants, legal attorney and chemist pharmacist.
1.2 Specialty name, pharmaceutical structure, and form of administration.
1.3 Complete formula of composition, qualitative/quantitative. If artificial food colouring agents are included, they must declared, as follows: FD&C blue #1, index colour #42090.
1.4 Therapeutic indication.
1.5 Contraindications and dosage.
1.6 Manufacturer’s name, place and country of manufacturing.
1.8 A statement given by the chemist pharmacist guaranteeing the truthfulness of data stated in numerals 1.2, 1.3, 1.4 and 1.5.
1.9 The application must be sealed and signed by both applicants.
The application has to go with the following documents:
Certificate of Free Sale issued by the corresponding health authority and duly legalized by the nearest Salvadoran Consulate or by Apostille, which must contain the product registration number given in its country of origin.
The certificate must contain:
● Trademark
● Generic name
● Pharmaceutical structure
● Concentration
● Manufacturer’s name
● Country of origin
● Registration number
● Registration expiration date (if applicable)
● Qualitative/quantitative formula
● Good Manufacturing Practices
● Certificate of Good Manufacturing Practices, if not included in the Certificate of Free Sale.
The original certificate or a certified copy issued by the statutory authority in the country of origin, must be in force.
The certificate and method of analysis must contain:
● Name of specialty and its pharmaceutical structure.
● Lot number, manufacturing and expiration date.
● Origin
● Chemical components and content declared.
● Bibliography consulted
The certificate and method of analysis must be printed in a company’s form or in a lab’s form duly authorized.
Important, this document must be sealed and signed by the professional who is responsible for the analysis of quality control and/or with the seal of approval of the lab’s quality control department. The description of method of analysis used for the finished goods (physical, chemical and/or microbiological tests) including calculations made, graphs obtained and bibliography consulted).
Chemical monograph of the pharmaceutical components must include:
● Physical and chemical properties
● Synonyms
● Structural formula and molecular weight
● Description
● Solubility
● Usages and incompatibilities with other chemical compounds
● Bibliography consulted
Pharmacological information of the pharmaceutical components in finished goods. Category (pharmacological classification), which must include:
● Indications
● Pharmacology (distribution, metabolism, excretion)
● Precautions
● Unfavourable results
● Dosing
● Overdose
Original certification of qualitative/quantitative composition of formula
● It must be sealed and signed by the person in charge of production or quality control
● Declare the artificial colouring used, with specifications given by the FDA and its certificate issued by the supplier.
● Medicines containing alcohol in the formulation must be declared with its volume and alcoholic degree.
Pharmacological literature of the pharmaceutical specialty.
● (Inserted: directed to the patient’s information and education).
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