Questions and answers on Art. 14 para. 1 letter abis-quater TPA

The procedure according to Art. 14 para. 1 letter a^bis TPA can be applied both for new and known active substances. Combinations of several active substances are also possible.

The time limits for the procedure according to Art. 14 para. 1 letter a^bis TPA are based on the application type (e.g. NA KAS, NA NAS or type II IE also possible). The time limits for the various application types are described in the Guidance document Time limits for authorisation applications.

There are no limitations to specific medicinal product categories.

Yes.

No, the interchangeability is not checked by Swissmedic in the simplified procedure according to Art. 14 para. 1 letter a^bis TPA. A standard application for the authorisation of a known active substance without innovation is required for the examination of interchangeability.

The authorisation date of the national reference authority to which the Information for healthcare professionals also refers is decisive.

There are no restrictions.

The pharmaceutical forms may differ but, according to the latest scientific and technical findings, any difference in the pharmaceutical form should not be expected to result in a different evaluation of efficacy and safety.

In the event of differences in pharmaceutical form, Swissmedic accepts, in addition to the documentation required by Guidance document Authorisation according to Art. 14 para. 1 letter a^bis-quater TPA, bioequivalence studies in order to be able to evaluate the impact of the difference on efficacy and safety.

In modules 2.6 and 2.7, Swissmedic expects a summary of the bibliographic data on non-clinical and clinical aspects. The selection criteria for the literature compilation (search strategy, list of searched databases, service providers) should also be presented in a transparent and comprehensible manner.

The documentation on quality must correspond to the latest scientific findings at the time of the authorisation application and must be complete. If the validation of the manufacturing process satisfies the currently valid requirements (Guideline on process validation for finished products - information and data to be provided in regulatory submissions, EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1), and if no changes have been made to the manufacturing process since the validation, then revalidation is not required. Any revalidation can be submitted at a later date as a condition, provided this is permitted by the above-mentioned Guideline (for a standard process). The analytical methods must be validated according to the ICH requirements at the time of submission.

Yes. Authorisation of a medicinal product according to Art. 14 para. 1 a^bis of the Therapeutic Products Act (TPA, SR 812.21) requires submission of documentation on pharmacological, toxicological and clinical studies according to Art. 4 and 5 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO, SR 812.212.22) or Art. 8 and 11 TPLRO for veterinary medicinal products. This may be submitted in bibliographic form if sufficient proof of the safety and efficacy of the medicinal product is available in the published specialist literature. Based on accumulated experience, Swissmedic will now accept submission on the basis of study reports or EU dossiers instead of bibliographic documentation.

Irrespective of which documentation the application is based on, the evidence submitted by the applicant must be summarised in a scientifically sound way and, for example evaluated critically by means of expert statements. For human medicinal products, this may also be in the form of a non-clinical / clinical overview (Module 2.4 / 2.5), or an expert report or detailed and critical summaries (DACS) for veterinary medicinal products.

The wording of the foreign product information should be taken over as a matter of priority, according to Art. 17b para. 4 TPLO. However, the product information texts must be supplemented by safety-related fixed and specimen texts according to Swissmedic requirements if these exist.

The crucial factor is that the sections of the product information (IHP and PI) specified in Art. 17b TPLO can be taken over only from a foreign comparator medicinal product. Comparability should be demonstrated between the medicinal product notified for authorisation and the comparator medicinal product whose product information texts are taken over.

No.

The requirements applicable to packaging are based on TPLRO. A list of countries in which the active substance is also authorised is not permitted.

Yes, medicinal product combinations can also be authorised according to Art. 14 para. 1 letter a^bis TPA. In this case the product information for the medicinal product combination is based on the comparator medicinal product sections specified in Art. 17b TPLO. In exceptional cases, Swissmedic will require the product information to be adapted to the Swiss requirements for safety-related aspects.

The key point is whether the active substance combination in a medicinal product combination has already been authorised for 10 years in the EU/EFTA.

No.

Art. 14 para. 1 letter a^bis TPA can also be used for additional indications, provided the medicinal product was already newly authorised according to Art. 14 para. 1 letter a^bis TPA. It should be noted that the sections of the product information (IHP and PI) specified in Art. 17b TPLO must be taken over from the same foreign comparator medicinal product. Mixing indications that are based on original documentation or indications that are based on a foreign comparator medicinal product are not permitted.

Swissmedic maintains its practice in respect of dispensing categories and classifies products in dispensing categories based solely on the criteria currently applicable in Switzerland.

This would involve a type IB variation (variation A.100)

No.

If the foreign comparator medicinal product is deleted in the reference country for marketing reasons, there will be no direct consequences for the authorisation status of the medicinal product authorised in Switzerland. The relevant note in the IHP / PI would probably be adapted to the new circumstances: "...is based on MEDICINAL PRODUCT NAME Y, which contains the same active substance(s) and has been authorised in COUNTRY Z for more than 10 years."

If the foreign comparator medicinal product is withdrawn from the market for safety reasons, the corresponding safety signals must also be reported to Swissmedic voluntarily (Art. 14a, para. 2 TPA). Furthermore, the authorisation holder is under an obligation to adapt the medicinal product information – continuously and without being prompted – in line with the state of the art in science and technology and with new events and assessments (Art. 28 TPO). If the authorisation holder does not withdraw the medicinal product voluntarily, Swissmedic would very probably initiate a review procedure and may well suspend the authorisation of the medicinal product for the duration of the procedure.

In this context, please also refer to question 1.33.

Yes. Bibliographic documentation comprises published literature ("public knowledge"). Therefore, the applicant does not need to rely on protected documents (clinical study results) for a medicinal product authorised in Switzerland.

Yes.

No. It is sufficient to prove that, at the time of submission, the active substance(s), indication, dosage, administration route and application in the target animal species have been authorised as a medicinal product (foreign reference medicinal product) in at least one EU or EFTA country for at least ten years.

In other words, the key requirement is that the active substance(s) must have been authorised in the EU/EFTA for ten years. How long the chosen foreign comparator medicinal product has been authorised is not relevant.

Yes, the chosen foreign comparator medicinal product must be authorised in the EU/EFTA when the application is submitted and at the time of Swissmedic's authorisation decision. However, if the foreign comparator medicinal product is withdrawn from the market at a later date for commercial reasons, the medicinal product authorised in Switzerland under Art. 14 para. 1 let. a^bis TPA can retain its authorisation provided the authorisation holder complies with all post-marketing obligations (see also 1.24).

No: according to Art. 12 TPLO para. 2, the reference medicinal product must have been authorised on the basis of complete authorisation documents; in other words,  all test results to which the KAS is supposed to refer must be contained in the documentation on the reference medicinal product.  In the Art. 14 para. 1 a^bis procedure, the documentation on preclinical and clinical efficacy and safety is only submitted in bibliographic form.

The UK has no longer been regarded as an EU/EFTA country since 1 January 2021. However, during a transitional period of five years, Swissmedic will continue to accept applications in accordance with Art. 14 para. 1 let. a^bis TPA that relate to 10-year authorisation of an active substance in the proposed indication (foreign reference medicinal product) in the UK. The authorisation of the active substance must have been granted before 1 January 2011. From 1 January 2026, this type of reference to a medicinal product authorised in the UK will no longer be permitted for new applications.

No. The date refers to the first authorisation and should not be revised when updates are made.

Yes. Since 26 May 2021, new authorisations have been required to comply with the new medical devices regulation and its practical interpretations. You can find further information in the publication on revised requirements regarding combination products on the Swissmedic website.

Non-exhaustive list of examples:

• Public Assessment Report that is older than 10 years or that shows the conditions under which the foreign reference medicinal product was authorised 10 years ago
• Confirmation from the therapeutic products authorities in the reference country
• SmPC or medicinal product information showing information that is older than 10 years

No. Authorisation according to Art. 14 para. 1 letter a^bis TPA is based on a specific foreign comparator medicinal product, which cannot be changed. The marketing authorisation holder is free to forgo the existing authorisation in Switzerland and to submit a new application with a different foreign comparator medicinal product.

In this context, please also refer to question 1.23.

The procedure according to Art. 14 para. 1 letter a^ter TPA can be applied both for new and known active substances. Combinations of several active substances are also possible.

The time limits for procedures according to Art. 14 para. 1 letter a^ter TPA are based on the application type (e.g. NA KAS, NA NAS or type II IE also possible). The time limits for the various application types are described in the Guidance document Time limits for authorisation applications.

Where the TPA exempts medicinal products from the obligation to be authorised (see Art. 9 para. 2 letter a-c^bis TPA), cantons may, within the scope of their powers, decide whether they wish to subject medicinal products to registration or reporting obligations.

Yes, deviations are possible if these accord with the dosage recommendation and the treatment regimen.

Yes, the company may use its own discretion to decide whether or not to issue Information for healthcare professionals.

Yes.

The requirements relating to the documentation for applications according to Art. 14 para.1 letter a^ter TPA vary considerably and depend on the therapy approach and the field of application. In order to clarify specific questions concerning documentation requirements, applicants can request Pre-Submission Advice from Swissmedic before submitting an application.

Usually yes. The documentation on medical use, safety and the therapeutic effect should be submitted in Module 5. (Summary in Module 2.5)

A complete and updated Module 3 on quality must be submitted. Accordingly, Swissmedic also expects a complete Module 2.3 "Summary on pharmaceutical quality".

Yes.

No.

The UK has no longer been regarded as an EU/EFTA country since 1 January 2021. However, during a transitional period of 15 years, Swissmedic will continue to accept applications in accordance with Art. 14 para. 1 let. a^ter TPA with a foreign comparator product from the UK.

From 1 January 2036, foreign comparator products from the UK will no longer be permitted.

The procedure according to Art. 14 para. 1 letter a^quater TPA can be applied both for new and known active substances. Combinations of several active substances are also possible.

The time limits for procedures according to Art. 14 para. 1 letter a^quater TPA are based on the application type (e.g. NA KAS, NA NAS or type II IE also possible). The time limits for the various application types are described in the Guidance document Time limits for authorisation applications.

The requirements relating to the documentation for applications according to Art. 14 para.1 letter a^quater TPA vary considerably and depend on the therapy approach and the field of application. In order to clarify specific questions concerning documentation requirements, applicants can request Pre-Submission Advice from Swissmedic before submitting an application.

Usually yes. The documentation on medical use, safety and the therapeutic effect should be submitted in Module 5. The Summary in Module 2.5

A complete and updated Module 3 on quality must be submitted. Accordingly, Swissmedic also expects a complete Module 2.3 "Summary on pharmaceutical quality".

In principle, Swissmedic does not check and approve any information for healthcare professionals when authorising a medicinal product according to Art. 14 para. 1 a^quater. However, the applicant can also prepare additional information for healthcare professionals at their own discretion and under their own responsibility if they believe this is necessary for the safe use of the medicinal product.

Yes.

No.