By: Jacqueline Castellanos
In El Salvador, the National Directorate of Medicines is the authority in charge of granting the permit for the Renewal of registration of cosmetic products, said 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 obtain its due approval.
Keep in mind that the renewal can be of two types, and this must be requested six months in advance: Sanitary registration renewal and Recognition Renewal, depending on the way in which the registration of the cosmetic product was made.
Currently the requirements required by the DNM are:
Sanitary Registration Renewal:
- Complete current form with the corresponding signatures.
- Sworn statement stating that the original conditions of the registration or approved modifications to the product registration are maintained.
- Number of proof of payment canceled for the procedure.
Recognition Renewal:
- Complete current form with the corresponding signatures.
- Original certificate of the renewal of registration or sanitary registration of the country of origin duly legalized.
- Complete qualitative formula, indicating the amounts of restricted substances with the stamp of the health authority.
- Number of proof of payment canceled for the procedure.
It is important to mention that prior to requesting the renewal of the cosmetic product, the following aspects should be considered:
- That the product is solvent for annuity payment.
- The information declared in the documents to be presented (owner name, manufacturer and product) coincide 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 registration conditions.
- The complete qualitative-quantitative formula must include the stamp 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 up.
The physical documents must be prepared to be presented at the DNM Cosmetics window, upon receiving favorable notification of the procedure.
With the appropriate advice, due follow-up to the regulatory processes of cosmetic products can be ensured to guarantee compliance with the quality standards of the product, marketing and sale.
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.