Immediate notification of the manufacture of a new active substance is required if it differs from active substances already listed in the manufacturing operations of the company’s ASR.
Examples include:
• Introduction of highly potent, sensitising active substances;
• Introduction of new technology or significant process changes.
Please note that this application form must be submitted as part of a variation or immediate notification of change to registration under the Falsified Medicines Directive (FMD) (2011/62/EU). The FMD requires that manufacturers, importers and distributors of active substances 'maintain' their registration with the local competent authority. Changes can occur at facilities (e.g. the introduction of the manufacture of new active substances) which can potentially have a quality and safety impact.