Variations to an Authorisation at Swissmedic

What are the four variation classes?

The TPO distinguishes between variations to be notified within twelve months (Art. 21), variations subject to prior notification (Art. 22), variations requiring approval (Art. 23), and variations requiring assessment (Art. 24). The annex to the TPO lists the categories and the documents required for each.

Anyone who treats a variation requiring approval as a mere notification is formally placing an unauthorised medicinal product on the market. This is the most common finding raised in inspections of marketing authorisation holders.

How does a variation application proceed?

You classify the variation using the TPO annex, assemble the documents it requires, and submit via the Portal. For variations requiring approval, Swissmedic reviews both form and substance and issues a decision. Only once that decision is issued may the variation be implemented.

1. Assign the variation to a class and category using the TPO annex.
2. Check the conditions and documents for the category; if not all are met, the class moves up.
3. Check grouping options: related variations can be bundled into one application.
4. Submit via the Swissmedic Portal, with updated dossier parts in CTD format.
5. Where approval is required, wait for the decision, then implement it and adjust batch release.
6. Update the medicinal product information via AIPS, where affected.

What timelines and fees apply?

Notifications under Art. 21 TPO must be submitted within twelve months of implementation. Prior notifications carry a waiting period, after which the variation may be implemented without a decision. Variations requiring approval take, depending on scope, a few weeks to several months.

• Notification under Art. 21 TPO: submission within twelve months, lowest fee.
• Prior notification under Art. 22 TPO: implementation after the waiting period expires.
• Variation requiring approval: processing typically takes two to four months.
• Variation requiring assessment: processing typically takes six to twelve months, with a round of questions.
• Grouped applications reduce the total fee compared with variations submitted individually.

What applies to renewal and the sunset clause?

The authorisation is valid for five years. The renewal application must be submitted at least six months before expiry and includes an updated benefit-risk assessment. Independently of this, under Art. 16a TPA the authorisation lapses if the medicinal product is not placed on the market within three years or is off the market for three years.