Chiara Ottavianelli -

With the new disposition DG/512/2019 of 12 March 2019, AIFA has updated the application of the assent-by-default procedure, in force since 2011 (with the AIFA disposition dated August 25th, 2011), extending it also to other types of variations.

In particular, the assent-by-default procedure will also be applied to type I variations of National, Mutual Recognition and Decentralized (MR/DC) procedures, related to:

THMPs (Traditional Herbal Medicinal Products) registered with a simplified authorization procedure;
type IB and IAIN variations concerning “quality” variations (group B of the Classification Guideline) for radiopharmaceuticals, biological/biotechnological medicinal products, vaccines, toxins, serums and allergens authorized with National procedure;
“safety” variations (group C of the Classification Guideline) to implement changes on the authorized texts where there is a reference wording in Italian approved by a Competent Authority (for example: PRAC recommendations not requiring a substantial change of the texts, referral implementation etc.).

According to the assent-by-default procedure, once the deadline provided by Regulation (EC) No. 1234/2008 has expired and in the absence of a negative opinion, even partial, by AIFA or the RMS, it will be possible to proceed with the implementation of the changes.

The MAH has the responsibility of the publication on the Official Journal within 45 days from the above-mentioned deadline using the templates provided on the AIFA website.

After the publication, the MAHs will have to upload through the AIFA Front END portal, as integration to the original variation procedure, a copy of the IOJ publication in pdf format and, if applicable, the updated texts in “track” version, with respect to the last authorized texts.

For type I variations regarding MRP/DCP medicinal products without impact on the MA decree and following the assent-by-default procedure it is not required the IOJ publication.

Regulatory Pharma Net team is available to support companies in the documents preparation and submission in order to comply with these requirements.

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