As of February 5, the new RTCA for registering cosmetic products will come into force, for which the following information must be included:
- In case a laboratory that is not a subsidiary or member of the same group is employed, a Manufacturing Contract (or manufacturer’s power of attorney as used in the case of Costa Rica) must be submitted.
- It will not be necessary to submit artwork for each product, but only that which changes the design and information for all products. In other words, by providing only one artwork change, the Authority will be aware that all the artwork is changed. This does not apply to kits, since the RTCA establishes that kits shall be regulated as established by each State that is a party.
- It will be possible to submit registration applications with more than one manufacturer and not wait for one to register and then add an alternate plant in all countries as is the case in Nicaragua and Panama.
- For formula change, finished product specifications will be required if there is a change in any specification, in which case a change in the finished product specifications will also be required.
- It is not necessary that between manufacturers they have the same presentations, i.e. manufacturer X can manufacture different presentations than Y. However, it must be the same owner, same formula and labeling (only one presentation can be presented, but the artwork must contain the same design and information).
- In case of renewal, the GMPs indicated in the sanitary registration must be submitted; therefore, these must be valid and up to date in order to renew the registration.
- Panama is the newest member of the Central American Technical Regulations for the cosmetics category.
For more information, contact us at [email protected]