By: Karla Salmeron, Olga Torres.
Changes that impact El Salvador according to the new RTCA of Medicines RTCA 11.03.59:18
In the general provisions section, it is included that correspond to the same registration:
1- Medicines with the same manufacturing site of the pharmaceutical form and formulation, but different primary or secondary packager. In this case, the packaging must declare the information of the primary and secondary packager, as appropriate.
2- Drugs with the same concentration and dosage form that have different packaging and closure systems, provided that they have stability studies that support each of these systems.
REQUIREMENTS FOR SANITARY REGISTRATION
Are included:
- For the item of Certificate of Pharmaceutical Product, in the case of Costa Rica, Guatemala, El Salvador, and Honduras a certificate of pharmaceutical product issued by a strict regulatory authority that approves the product will be accepted, even though it is not the country of origin, provenance or holder, this in the case of first registration of products whose safety and efficacy has not been documented in the official literature, and to guarantee early access to medicines never before registered.
- Pigments and colorants used at any stage of the manufacture of the product must be declared in the formula, including the code “color index, C.I”, the code “Food Drug and Cosmetic, FD&C” or another equivalent.
- In the composition of empty capsules, the number of capsules used must be declared.
MUTUAL RECOGNITION OF SANITARY REGISTRATION OF MEDICINAL PRODUCTS FOR HUMAN USE
The term for the resolution of the procedure is extended to 10 working days.