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Spain: New AEMPS application for registration of biocidal products and personal care products

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In brief

The Spanish Agency for Medicinal Products and Medical Devices (“AEMPS“) has launched a new application with the aim of facilitating the registration and improving the communication of biocidal products and of personal care products, as well as regarding facilities that manufacture, import and store biocidal products within the Spanish territory.

In more detail

This new application has been fully operational since 29 April 2022, replacing the obsolete COSMET, which had been active since 2004. All product and facility data collected in the old application have been migrated to the new one. However, COSMET shall not close until the end of 2022 to allow companies to check that the information has been migrated correctly.

The new computer system allows interested parties to carry out the following procedures:

  • Authorization of biocides and personal care products.
  • Modification and revalidation of the authorization of biocides and personal care products.
  • Authorization of manufacturing, import and storage facilities for biocidal products located in Spain.
  • Modification and revalidation of the above biocidal facilities’ authorizations.
  • Electronic payment of fees and downloading of digitally signed authorizations.

Therefore, from now all the applications for the above procedures with the AEMPS must be done through this new platform, which can be accessed by clicking on this link.

To access the application, national companies must identify themselves through the CLAVE platform, while foreign companies must select their country of origin and identify themselves by e-mail and password. The new home screen of the application will display the list of active applications at any given time, both for products and facilities, sorted by seniority. The AEMPS has published a complementary user manual for the new application, which can be consulted at this link.

The AEMPS has also published new instructions for the application for authorisation of personal care products, which can be reviewed by clicking on this link. The application takes into account the existence of wide variety of personal care products, with specific information being requested for each type of product.  In Spain, the commercialization of personal care products requires prior authorisation from the AEMPS. In this regard, companies shall submit to the AEMPS the technical documentation of the product (safety and efficacy), the information provided to end users and an assessment report on the classification, labelling and packaging of the finished product, in line with the implementation of the objectives of the EU Sustainability Strategy for Chemicals.

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Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

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