Cosmetics: licences, compliance, and market access
At Medical Devices Sur Consulting, we specialise in providing pharmaceutical consulting services and legal advice throughout Spain.
We help you market cosmetic products in compliance with the applicable regulations, preparing the required documentation and processing the registrations needed to sell safely in Spain and the EU.
Our team of experts is ready to provide you with more information and offer you a free consultation.
Personalised approach
We are defined by our personalised approach, adapting to the specific needs of each client and providing an agile, reliable, and efficient service. We work with the commitment to ensure that our clients’ products comply with all applicable regulations, facilitating their access to the market and ensuring their success in a competitive environment.
Legal advice for cosmetic products
In addition to ensuring that all health and legal documentation is compliant, it is necessary to verify that the physical facilities and the activities inherent to the marketing and distribution of the product comply with the legal requirements established by the AEMPS.
At Medical Devices Sur Consulting, we provide you with the necessary guidelines so that your product can be received, stored, traced, released, and distributed with all health guarantees.
More on traceability and product release
Perhaps the most important point in all these processes is traceability, as it is always necessary to keep the movement of the product under control both forwards and backwards, in case there is ever an adverse event associated with the use of the product, requiring the implementation of all legally established protocols to determine the cause and the action taken by the person responsible for placing the product on the market.
On the other hand, the release of the product is also essential. At this stage, the technical manager must directly verify that the product meets all regulatory requirements (labelling and instructions for use comply with applicable regulations) so that it can be released and placed on the market.
This release must always be properly recorded and signed by the technical manager.
Cosmetics licences
At Medical Devices Sur Consulting, we offer specialised services in the management of licences and the registration of cosmetic products to ensure their marketing in accordance with current regulations. We handle the submission of the Responsible Declaration to the competent authorities, ensuring that the product meets the safety, efficacy, and labelling standards set out in Regulation (EC) No 1223/2009.
In addition, we manage product notification in the Cosmetic Products Notification Portal (CPNP), a mandatory requirement for sale in the European Union. Our team also provides technical and regulatory advice, verifying that formulas, packaging, and documentation meet legal requirements.
We handle all procedures, ensuring that your cosmetic products meet all the standards required for distribution and commercial success.
Preparation of the national code application for cosmetic products
The national para-pharmacy code is a 7-digit code: 6 digits corresponding to the product itself plus a check digit, which facilitates the identification and marketing of the product to end customers such as pharmacies or clinics.
Although it is not mandatory for products, it greatly facilitates identification and traceability.
If you are interested in obtaining this code, we can also assist you with its management and acquisition.