Last August, the AIFA, Agenzia Italiana del Farmaco (= Italian Medicines Agency) has provided important clarifications about its own communiqué, published on 15 June 2016: (in italian)“Regolamento delegato UE 2016/161 e precisazioni in merito all’attività di apposizione del bollino (15/06/2016)”. Within the text (in italian) “Chiarimenti in merito alla comunicazione AIFA relativa all’attività di apposizione del bollino farmaceutico (17/08/2017)” it’s specified that the activity of labelling a pharmaceutical packaging can be considered a packing activity just in case the label is applied on packagings containing medicines. In these cases the labelling activity must lie exclusively to the manufacturer or to the laboratories authorized by AIFA, in accordance to EU GMP.

On the other hand, it’s not necessary that the activity of labelling an empty pharmaceutical packaging carton is carried out by the manufacturer or an authorized laboratory, but can be implemented by other appropriate factories and sent to the production facility designated for medicines packing, according to EU GMP.

FAVILLINI’s labelling department

In 2013 we created a labelling department that is only accessible with a pass.

This department means that we can supply our clients with pharmaceutical labels by applying specific procedures with careful checks from the moment the client’s labels enter our plant until delivery of the materials to which they are applied, this includes complete accounting of goods and delivery of any waste materials. The sequential numbering of the labels is included on a different label on the outside of the collective packaging and bears the sequential numbering of those on the packets.

This new department is able to label 30,000/50,000 packets a day.