Art. 13 TPA: Using a Foreign Authorisation

Which authorities count as comparable?

In practice these are the EMA and the authorities of the EU member states, the FDA, Health Canada, the MHRA, the TGA in Australia and the HSA in Singapore. The last four form the Access Consortium together with Swissmedic, which enables work-sharing and joint assessments.

The EMA and national authorities of the EU and the EEA.
The FDA (United States).
Access Consortium: Australia (TGA), Canada (Health Canada), Singapore (HSA), United Kingdom (MHRA), Switzerland (Swissmedic).
For global health products, additionally the MAGHP procedure involving WHO process participation.

What additional documents does Swissmedic require?

You submit the complete CTD and enclose the foreign authority's authorisation decisions, assessment reports and approved product information. A complete comparison is central: what is identical, what differs, and why. Any unexplained deviation becomes a question in the List of Questions.

Documents for an application under Art. 13 TPA
Document	Purpose	Common mistake
Foreign authority's authorisation decision	Proof of authorisation	Only the approval letter, without annexes
Assessment report, unredacted	Basis for consideration	Redacted version without the evaluation section
Approved product information abroad	Comparison with the Swiss version	Outdated version
Deviation table, Swiss dossier versus foreign dossier	Focusing the assessment	Missing or incomplete
Current status of foreign variations	Consistency of the data	Ongoing variations not mentioned
Swiss Module 1	Trilingual information, proof of domicile	Direct translation without adaptation to the Swissmedic template

Where does consideration stop?

Swissmedic remains responsible for the Swiss decision and assesses benefit and risk for the Swiss care situation independently. Indications, dosages, dispensing category and warnings can differ from those abroad. A refusal abroad must be disclosed and is likewise taken into account.

The dispensing category is determined afresh under Swiss law, independent of the position abroad.
Indication wording is adapted to the comparators available in Switzerland.
The medicinal product information follows the Swissmedic template, not the EU SmPC layout.
Applications refused or withdrawn abroad must be disclosed.

What does the procedure actually save?

The time saving is around 130 days of regulatory time compared with the standard procedure, because one round of questions is avoided. The fee is lower than for a full fresh assessment. The bigger effect is internal: the effort of answering scientific questions falls, because the reasoning is already fully worked out.

Frequently asked questions

Is Art. 13 TPA automatic recognition of an EU authorisation?

No. Swissmedic must take the foreign assessment results into account, but it decides for itself. There is no mutual recognition agreement for medicinal product authorisations between Switzerland and the EU.

Do I need the unredacted assessment report?

Yes; without the evaluation section, Swissmedic cannot take the assessment results into account. If it is missing, the application is effectively assessed like a standard application.

Can I use Art. 13 TPA for generics too?

Yes. A generic authorised abroad can rely on the assessment results obtained there, provided the reference product and the bioequivalence data can be transferred to the Swiss situation.

What is the Access Consortium?

A coalition of the authorities of Australia, Canada, Singapore, the United Kingdom and Switzerland. It enables joint or work-shared assessments on a coordinated timetable, with each authority still taking its own national decision.

Is the Swiss dispensing category taken over from abroad?

No. Classification into categories A, B, D or E is made under Art. 40 et seq. TPO and can differ from the prescription status abroad.

Art. 13 TPA: Authorisation Using Foreign Assessment Results