In El Salvador, the National Directorate of Medicines is the authority responsible for granting the permit for the renewal of the registration of cosmetic products, this permit must be renewed every 5 years so that its marketing can continue in force, for this it must know the requirements to process it, the previous time to apply for it and get its proper approval. Keep in mind that the renewal can be of two types, and must be requested six months in advance: Renewal of health registration and Renewal by recognition, depending on how the registration of the cosmetic product was made. carried out.
Currently, the requirements required by the DNM are:
Renewal of health registration:
- The current form is complete with the corresponding signatures.
- Affidavit stating that original conditions of registration or approved changes to product registration are maintained.
- Number of the payment document canceled for the procedure. Renewal of recognition:
- Completed form in force with the corresponding signatures.
- Original certificate of renewal of health registration or health registration from the country of origin, duly legalized.
- Complete qualitative formulation, indicating the quantities of regulated substances with the stamp of the health authority.
- Proof of payment number canceled for the procedure. It is important to mention that before requesting the renewal of the cosmetic product, the following aspects must be considered:
- That the product is solvent annuity payment.
- The information declared in the documents to be presented (name of holder, manufacturer and product) coincides with what is authorized.
- No post-registration procedure is in progress at the time of the cosmetic product renewal request.
- All documents must be duly legalized.
- The affidavit must accurately reflect the conditions for registration in effect.
- The complete qualitative-quantitative formula must bear the seal of the health authority of the country of origin.
Note: The cosmetic product renewal process is carried out by the professional responsible for the product in the online system, attaching the previously mentioned documents; at the end of the process, an application number is received with which the renewal process will be followed.
The physical documents must be prepared for presentation to the Cosmetic Counter of the DNM, upon receipt of the favorable notification of the process.
With the right guidance, you can ensure proper monitoring of cosmetic product regulatory processes to ensure product quality, marketing, and sales standards are met.
If you need advice, you can contact our team of professionals in the Life Sciences-Regulatory Affairs field through the communication channels indicated on our platforms.