In order that an immunological medicine or a medicine derived from human blood and plasma be marketed in an EU country, each individual batch must pass the State Control procedure by obtaining a "batch release" certificate from the Official Laboratory of Control (Official Medicines Control Laboratory, OMCL) of a Member State or of a State with which mutual recognition agreements are in force. The Official Control Laboratory in Italy is the Istituto Superiore di Sanità (ISS).
Batches without the release certificate cannot be marketed in any EU country and related information is shared through the official OMCL network or the Network Official Control Authority Batch Release (OCABR).
Upon requesting AIFA to market a specific batch of an immunological drug or medicinal product derived from human blood or plasma, the MAH and/or the licensee is required to send the following documentation to the Product Quality and Pharmaceutical Crime Counteracting Office, through the certified email address firstname.lastname@example.org .
Information on the documentation to be submitted to AIFA
If the applicant is a MAH, all the documentation relating to the Batch Release request must be prepared by the MAH and sent through the licensee. The latter is required to notify the office of the MA, specifying it on the request cover and attaching all the documentation certifying this authorization.
The official start of the procedure (start-up) is marked by the date and the protocol number assigned to the request that are sent by e-mail from the Product Quality and Pharmaceutical Crime Counteracting Office to the applicant.
AIFA has deemed it useful to define two different procedures: ordinary and urgent. The ordinary procedure must be completed by 7 working days, at the end of which, if AIFA has not raised any objections (silent consent), the batch can be marketed. The urgent procedure, justified by particular situations, such as the risk that a shortage on the market may occur relating to a particular medicine, must instead be completed within 3 working days, at the end of which, following the release of the authorization by AIFA, the batch can be marketed.
If the documentation does not comply with the requirements, AIFA sends the MAH and/or the licensee a request for clarification and/or additional documentation. This request suspends the terms of the procedures which start from scratch upon receipt of the necessary additional documentation. The new terms are notified to the applicant via certified email (PEC).
Batch release for seasonal influenza vaccines
The procedure concerning influenza vaccines follows a specific process, as the marketing of these is subject to the entry into force of the AIFA resolution relating to the updating of influenza viral strains for the current season.
The MAHs can still submit to the office the marketing authorization requests for influenza vaccines prior to the publication of the AIFA resolution and before the issue of the specific annual circular by the Ministry of Health, using only the ordinary procedure.
However, up to the date of publication of the AIFA resolution, the release procedure cannot be considered concluded with the “silent consent” mechanism.
- Copy of the Batch Release (CBR) certificate, certificate issued by the OMCL of a Member State (including Italy) or of a State with which mutual recognition agreements are in force, if applicable also to this sector.
- Marketing Information Form (MIF), a model of notification of the applicant's intention to market a specific batch, in which all the information relating to the batch is reported (e.g. trade name, batch number, validity date, expiry date, etc.).
- Batch Release procedure cover, which identifies the type of procedure requested, which can be identified as ordinary or urgent.