When a recall procedure is required due to quality product defects, the Company GMP Qualified Person must inform immediately AIFA Quality Office and in parallel start an efficient and rapid recall procedure.
The Marketing Authorisation Holder (MAH) in fact has to perform without delay the following actions:
- inform distributors, logistic sites, trade associations, hospitals in order to block the use of the medicinal product and to make safe the product with defect at all distribution levels
- verify unsold stocks, verify sold stocks and recipients
- verify the presence of product in the in progress distribution
- have the complete traceability of all batches
In Italy AIFA issues a communication that confirms the recall performed by the MAH and informs accordingly several trade associations (e.g. Pharmacists association, etc) , Italian databases, Istituto Superiore di Sanità (ISS), NAS (department of the National Military Police responsible for control of medicines), Regions, etc. In order to safeguard the public health, AIFA consequently prohibits the sale of the relevant batch of the medicinal product for the entire time duration of the AIFA measure.
In the same communication AIFA includes also the timing granted to the MAH to prove the activation of the recall procedures (i.e. within 48 hours starting from the receipt of the AIFA communication, MAH must communicate to all its customers the start of the recall procedure so that the concerned medicinal product from the time of the communication cannot be sold anymore. The practical recall of packs can take longer).
Usually also NAS is involved to verify that the above mentioned activity has been properly done checking the documents provided by the MAH and performing audits, as required.
In order to properly manage the above circumstance, the MAH and all parties involved in the distribution of the medicinal product must have detailed procedures, with a clear definition of the responsibilities, for the management of recalls of medicinal product batches from the Italian market.