By: Jackeline Castellanos
In El Salvador, the National Directorate of Medicines is the authority in charge of granting the permit for the Renewal registration of cosmetic products, such permit must be renewed every 5 years so that its commercialization can continue in force, for this it is necessary to know the requirements to process it, the previous time to request it and to obtain its due approval.
Keep in mind that the renewal can be of two types, and this must be requested six months in advance: Renewal of sanitary registration and Renewal by Recognition, depending on how the registration of the cosmetic product was carried out.
Currently, the requirements required by the DNM are:
Renewal of Sanitary Registration:
- Current form is complete with the corresponding signatures.
- Affidavit stating that the original conditions to the registration or approved modifications to the product registration are maintained.
- Number of the payment voucher canceled for the procedure.
Renewal of Recognition: - Completed form in force with the corresponding signatures.
- Original certificate of registration renewal or sanitary registration from the country of origin, duly legalized.
- Complete qualitative formulation, indicating the quantities of restricted substances with the stamp of the sanitary authority.
- Number of proof of payment 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 of payment of annuity.
- The information declared in the documents to be presented (name of the holder, manufacturer, and product) coincides with what is authorized.
- No post-registration procedures are in process at the time of requesting the renewal of the cosmetic product.
- All documents must be duly legalized.
- The Affidavit must faithfully indicate the current conditions of registration.
- The complete quality-quantitative formula must include the seal of the sanitary authority of the country of origin.
Note: The renewal process for cosmetic products 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, a request number is received with which the renewal process will be followed up.
The physical documents must be prepared to be presented at the Cosmetics window of the DNM, upon receiving the favorable notification of the process.
With the right advice, you can ensure the proper monitoring of the regulatory processes of cosmetic products to ensure compliance with product quality standards, marketing, and sales.
If you need any advice, you can contact our team of professionals in the Life Sciences-Regulatory Affairs area through the communication channels indicated on our platforms.