Source: https://www.swissmedic.ch/swissmedic/en/home/services/documents/faq_art14abs_1bst_abis-quater_hmg.html
Timestamp: 2020-07-12 09:10:01
Document Index: 402255889

Matched Legal Cases: ['Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 17', 'Art. 17', 'Art. 14', 'Art. 17', 'Art. 14', 'Art. 14', 'Art. 17', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 17', 'Art. 14', 'Art. 14', 'Art. 28', 'Art. 14', 'Art 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 9', 'Art. 14', 'Art. 17', 'Art. 14', 'Art. 14', 'Art. 14', 'Art 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art. 14', 'Art 14', 'Art. 14', 'Art. 14', 'art14']

Questions and answers on Art. 14 para. 1 letter abis-quater TPA HMV4
1. Art. 14 para. 1 letter abis TPA
2. Art. 14 Abs. 1 Bst. ater HMG
3. Art. 14 para. 1 letter aquater TPA
1.1	Can both known and new active substances be submitted according to Art. 14 para. 1 letter abis TPA?
The procedure according to Art. 14 para. 1 letter abis TPA can be applied both for new and known active substances. Combinations of several active substances are also possible.
1.2	What time limits apply to the procedure according to Art. 14 para. 1 letter abis TPA?
The time limits for the procedure according to Art. 14 para. 1 letter abis 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 HMV4.
1.3	Do the procedures according to Art. 14 para. 1 letter abis TPA apply only to synthetic products, or can e.g. biologics, herbal medicinal products, transplant products or vaccines also be submitted in these procedures?
There are no limitations to specific medicinal product categories.
1.4	Can an application that has been rejected by Swissmedic be resubmitted according to Art. 14 para. 1 letter abis TPA if all conditions are fulfilled?
1.5	Can a medicinal product also be authorised according to Art. 14 para. 1 letter abis TPA as interchangeable with a Swiss reference product?
No, the interchangeability is not checked by Swissmedic in the simplified procedure according to Art. 14 para. 1 letter abis TPA. A standard application for the authorisation of a known active substance without innovation is required for the examination of interchangeability.
1.6	What date is decisive for the calculation of the 10-year period in a Mutual Recognition Procedure? The authorisation date of the national authority (e.g. in UK) or the MRP authorisation date (day 90)?
The authorisation date of the national reference authority to which the Information for healthcare professionals also refers is decisive.
1.7	Can all pharmaceutical forms be submitted, or are there restrictions?
1.8	Does the pharmaceutical form of the notified medicinal product have to be the same as that of the foreign reference product?
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 abis-quater TPA HMV4, bioequivalence studies in order to be able to evaluate the impact of the difference on efficacy and safety.
1.9	What requirements exists for modules 2.6 and 2.7?
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.
1.10	If a revalidation of the manufacturing process and the analytical methods is required in connection with the updating of module 3, can this be implemented after authorisation? What post-approval commitments (PAC) are possible?
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.
1.11	Can study reports also be submitted instead of publications? (Modified on 1 May 2020)
In the greatly simplified procedure according to Art. 14 para. 1 letter abis TPA, a review of original clinical documentation is generally only admissible for bioequivalence studies, e.g. where the pharmaceutical forms differ.
As an addition to the bibliographical documentation, Swissmedic accepts findings from non-published clinical study reports as supporting evidence, provided the results of the studies have been assessed and shown to be scientifically reliable and are accompanied by an expert statement. In the expert statement, the applicant must critically evaluate these study results in terms of efficacy and safety as part of an overall summary of the evidence submitted. Moreover, the expert statement should state the extent to which the study results are applicable to the medicinal product for which authorisation is being applied for and to the foreign reference medicinal product, and should critically evaluate any deviations e.g. in terms of composition and pharmaceutical form.
1.12	When applying Art. 14 para. 1 letter abis TPA, can the EU dossier be submitted 1:1 instead of bibliographic documentation?
1.13	As regards the product information, according to Art. 17b TPLO, sections 4-16 of the Information for healthcare professionals and sections 3-9 of the Patient information should be taken over from the foreign product information texts. However, specimen text requirements apply in Switzerland to certain medicinal product groups (e.g. paracetamol or NSAID). Are these specimen texts used?
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.
1.14	When applying Art. 14 para. 1 letter abis TPA, can reference be made to several EU/EFTA reference products with the same active substance?
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 reference product. Comparability should be demonstrated between the medicinal product notified for authorisation and the reference product whose product information texts are taken over.
1.15	Does the product information still need to be referenced when Article 14 para. 1 letter abis TPA is applied?
1.16	If the medicinal product has been authorised in several countries for more than 10 years, can all of these countries be listed on the packaging?
The requirements applicable to packaging are based on TPLRO. A list of countries in which the active substance is also authorised is not permitted.
1.17	Can medicinal product combinations also be authorised according to Art. 14 para. 1 letter abis TPA?
Yes, medicinal product combinations can also be authorised according to Art. 14 para. 1 letter abis TPA. In this case the product information for the medicinal product combination is based on the reference 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.
1.18	Can an application for the authorisation of a medicinal product combination according to Art. 14 para. 1 letter abis TPA be submitted if only the two monopreparations have been authorised in the EU/EFTA for over 10 years?
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.
1.19	Is it possible, for a medicinal product authorised according to Art. 14 para. 1 letter abis TPA, to request "new" indications based on new clinical, published studies as additional indications, if these indications are not authorised for the foreign reference product on which the initial authorisation was based?
1.20	Can the procedure according to Art. 14 para. 1 letter abis TPA be used not only for new authorisations but also for additional indications for medicinal products that are already authorised in Switzerland?
Art. 14 para. 1 letter abis TPA can also be used for additional indications, provided the medicinal product was already newly authorised according to Art. 14 para. 1 letter abis 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 reference product. Mixing indications that are based on original documentation or indications that are based on a foreign reference product are not permitted.
1.21	It is possible that an EU reference product possesses OTC status but would be classified in Switzerland as a prescription-only medicine based on the indication, active substance, dosage strength or pack size. In what dispensing category would such a medicinal product be classified in Switzerland?
Swissmedic maintains its practice in respect of dispensing categories and classifies products in dispensing categories based on the currently applicable criteria.
1.22	Under what variation category should an adaptation of the Swiss product information to the foreign reference product be submitted? As a type IA or IB variation or type II variation?
This would involve a type IB variation (variation A.100)
1.23	Can variations in quality be submitted according to Art. 14 para. 1 letter abis TPA?
1.24	What happens if the foreign reference product is deleted (marketing reasons) or withdrawn (safety reasons)?
If the foreign reference 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 reference product is withdrawn from the market for safety reasons, the corresponding safety signals must also be reported to Swissmedic (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 temporarily suspend the medicinal product.
1.25	Can document protection based on a bibliographic application in the procedure according to Art. 14 para. 1 letter abis TPA and still applicable in Switzerland be circumvented if this has already expired in the EU?
Yes. Since bibliographic documentation comprises published literature ("public knowledge") it is not subject to any document protection. Therefore, the applicant does not need to rely on protected documents (clinical study results) for a medicinal product authorised in Switzerland.
1.26	Can authorisations granted in the procedure according to Art 14 para. 1 letter abis TPA also serve as a basic authorisation for a co-marketing medicinal product?
1.27	Is it essential for the chosen foreign reference medicinal product to have been authorised in the EU/EFTA for at least 10 years?
No. It is sufficient for the active substance(s) of the foreign reference product to have been contained in a medicinal product that has been authorised for an identical indication in an EU/EFTA country for at least 10 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 reference product has been authorised is not relevant.
1.28	Does the chosen foreign reference medicinal product have to be authorised when the application is submitted?
Yes, the chosen reference medicinal product must be authorised in the EU/EFTA when the application is submitted. However, if the foreign reference 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. abis TPA can retain its authorisation provided the authorisation holder complies with all post-marketing obligations (see also 1.24).
2. Art. 14 para. 1 letter ater TPA
2.1	Can both known and new active substances be submitted according to Art. 14 para. 1 letter ater TPA?
The procedure according to Art. 14 para. 1 letter ater TPA can be applied both for new and known active substances. Combinations of several active substances are also possible.
2.2	What time limits apply to the procedure according to Art. 14 para. 1 letter ater TPA?
The time limits for procedures according to Art. 14 para. 1 letter ater 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 HMV4.
2.3	Will cantonal authorisations still be possible?
Where the TPA exempts medicinal products from the obligation to be authorised (see Art. 9 para. 2 letter a-cbis TPA), cantons may, within the scope of their powers, decide whether they wish to subject medicinal products to registration or reporting obligations.
2.4	For applications according to Art. 14 para. 1 letter ater TPA, can the requested pack sizes deviate from those of the foreign medicinal product if this is deemed to be appropriate?
Yes, deviations are possible if these accord with the dosage recommendation and the treatment regimen.
2.5	Under Art. 17c para. 1 TPLO, Information for healthcare professionals can be omitted from applications according to Art. 14 para. 1 let. ater TPA. Is it possible to produce Information for healthcare professionals on a voluntary basis so that this can be made available to the professionals concerned?
Yes, the company may use its own discretion to decide whether or not to issue Information for healthcare professionals.
2.6	Are "30 years of medical use in another country" and "15 years of medical use in the EU / EFTA" conditions that must be fulfilled cumulatively?
2.7	What expectations does Swissmedic have relating to documentation on the therapeutic effect and the undesirable effects?
The requirements relating to the documentation for applications according to Art. 14 para.1 letter ater 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.
2.8	Are Modules 5 and 2.5 required?
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".
2.9	Is an "Information for healthcare professionals" for applications in the procedure according to Art. 14 para. 1 letter ater TPA merely "not necessary" or is it also "not permitted"?
An "Information for healthcare professionals" is not permitted.
2.10	Can authorisations granted in the procedure according to Art 14 para. 1 letter ater TPA also serve as a basic authorisation for a co-marketing medicinal product?
2.11	Can variations in quality be submitted according to Art. 14 para. 1 letter ater TPA?
3.1	Can both known and new active substances be submitted according to Art. 14 para. 1 letter aquater TPA?
The procedure according to Art. 14 para. 1 letter aquater TPA can be applied both for new and known active substances. Combinations of several active substances are also possible.
3.2	What time limits apply to the procedure according to Art. 14 para. 1 letter aquater TPA?
The time limits for procedures according to Art. 14 para. 1 letter aquater 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 HMV4.
3.3	What expectations does Swissmedic have relating to documentation on the therapeutic effect and the undesirable effects?
The requirements relating to the documentation for applications according to Art. 14 para.1 letter aquater 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.
3.4	Are Modules 5 and 2.5 required?
Usually yes. The documentation on medical use, safety and the therapeutic effect should be submitted in Module 5. The Summary in Module 2.5
3.5	Is an "Information for healthcare professionals" for applications in the procedure according to Art. 14 para. 1 letter aquater TPA merely "not necessary" or is it also "not permitted"?
3.6	Can authorisations granted in the procedure according to Art 14 para. 1 letter aquater TPA also serve as a basic authorisation for a co-marketing medicinal product?
3.7	Can variations in quality be submitted according to Art. 14 para. 1 letter aquater TPA?
Questions and answers on Art. 14 para. 1 letter abis-quater TPA HMV4 (PDF, 318 kB, 01.05.2020)
https://www.swissmedic.ch/content/swissmedic/en/home/services/documents/faq_art14abs_1bst_abis-quater_hmg.html