On June 2nd, 2021, the resolution from the AEMPS to the Regulation (EU) No. 528/2012, which attributes the status of medicine for human use to “antiseptics intended for the preoperative surgical field and for disinfection of the injection site”, came out.
Although these products may continue to be manufactured and marketed as biocides until June 1st, 2022, this approval has a significant impact due to the switch from Biocides to medicines, such as:
- The Manufacturer will have to comply with GMP and use active ingredients also manufactured with GMPs.
- A Technical Dossier that complies with the regulations required for medicines will have to be prepared, Modules 1 to 5, in eCTD format.
- As for any commercializing company located in Spain, if not previously authorized by the AEMPS as the Marketing Authorization Holder of Medicinal Products with warehouse (laboratorio titular), they will need to prepare the necessary documentation and request registration, have a technical responsible, as well as their own or subcontracted warehouse, duly authorized for the storage of medicines.
ASPHALION can help you in the preparation of the necessary documentation and the procedures with the AEMPS until the obtention of the requested authorizations.
Contact us at: [email protected] and we will provide you with more information!
