How to participate in SIGRE
SIGRE is the authorised system in Spain for the environmental management of waste medicines and their packaging generated in households.
Through SIGRE, member companies comply with both environmental and health regulations, guaranteeing compliance with the environmental aspects related to the management of this waste.
Therefore, as established by the Spanish Agency of Medicines and Health Products (AEMPS) in Circular No. 3/2013, if a pharmaceutical company markets medicines for use in private homes, it must join SIGRE.
Through this Circular, and in order to comply with the provisions of article 62.6 of Royal Decree 1345/2007, the AEMPS has created a procedure to ensure that holders of medicines authorisations are adhered to the SIGRE System.
To this end, prior to the marketing of any new medicine, pharmaceutical companies must submit to the AEMPS a certificate accrediting their participation in the SIGRE System.
Those who wish to initiate the accession process should send the following Information Form on the SIGRE accession procedure.
If you have any questions about this process, please contact SIGRE on 91 391 12 30.
In addition, once the company is a member, through the "SIGRELAB Form" application, it must provide SIGRE with information on the number, weight and material of the packaging of the pharmaceutical products marketed.