Source: https://www.swissmedic.ch/swissmedic/en/home/services/documents/faq-art-13.html
Timestamp: 2019-12-09 03:02:36
Document Index: 673818714

Matched Legal Cases: ['Art. 13', 'Art. 59', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art.13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 13', 'Art. 10', 'Art. 13', 'art-13']

Questions and answers Art. 13 TPA
1. Is it no longer necessary to notify Swissmedic if it is more than two years since a medicinal product was last marketed in the countries in which it was authorised?
No. Provided the product was withdrawn on purely commercial grounds, there is no longer any requirement to notify Swissmedic. However, if sale of the product has been restricted or stopped in other countries because of safety signals, these signals are subject to the mandatory notification requirement under Art. 59 TPA and Arts. 61 and 62 TPO. In such cases, Swissmedic has to be notified of the withdrawal. Consequently, a medicinal product may be withdrawn in another country for entirely market-related reasons without the withdrawal affecting its authorisation status in Switzerland.
2. Is it possible to apply for authorisation of a co-marketing product of a medicinal product that has been authorised under Art. 13 TPA, and, if so, are the requirements the same as for applications for medicinal products authorised under the regular procedure?
Yes, the requirements are identical.
3. The final report on readability testing has been inserted as section 1.3.4 of the reference country’s Module 1. Does this report also have to be submitted?
Yes, the documentation submitted to Swissmedic has to be identical to that on which the reference authority based its authorisation of the medicinal product (see also Chapter 5.1 of guidance document Authorisation of human medicinal products under Art. 13 TPA HMV4).
4. If pharmacovigilance planning or other updated documents are available for an application for authorisation of or for a variation to a medicinal product under Art. 13 TPA, should applicants provide the documents submitted to the reference authority for the original procedure or the updated versions of those documents? And in what form should they submit the documents?
The documentation submitted to Swissmedic must be identical to that on which the reference authority based its authorisation of the medicinal product or a variation to the product (final version). In parallel with the application, the variations and/or additions approved since the reference authority granted authorisation must also be submitted to Swissmedic. This additional or replacement documentation can either be integrated within the application documentation or the module in question, or it can be submitted separately. The variations must be referred to in the cover letter, and a comparison showing the changes (old/new) must be appended to the corresponding final assessment report (see also Chapter 5.1 of guidance document Authorisation of human medicinal products under Art. 13 TPA HMV4).
5. When applying for authorisation of a medicinal product that has been authorised in over 20 EU states under a DCP, do the decisions of all 20 states have to be submitted?
Any application for a medicinal product under Art. 13 TPA that is based on an EU DCP only needs to include the assessment results and authorisation decision of the Reference Member State (RMS). The decisions and authorisation certificates of the Concerned Member States (CMS) no longer have to be submitted to Swissmedic.
6. Once formal control has been completed, should new variations to an ongoing procedure under Art. 13 TPA be submitted subsequently or as variations (major variations, type II, or minor variations IA/IAIN/IB)?
Until such time as a procedure has been completed, subsequently submitted variations that have been approved by the reference authority count as part of the ongoing procedure. Depending on the extra workload incurred, it may be necessary to extend the duration of the procedure and levy an additional fee.
7. If a medicinal product was approved under Art. 13 TPA, can variations also only be submitted under Art. 13 TPA?
No, once a medicinal product has been authorised under Art. 13 TPA, applications for variations can be submitted either with or without a request for application of Art. 13 TPA.
8. Can applications for the authorisation of herbal and complementary medicinal products be submitted under Article 13 TPA?
Yes, Art. 13 TPA can also be applied to applications for the authorisation of herbal and complementary medicinal products.
9. What documents are needed for a Repeat Use Procedure MRP?
Wir möchten die Zulassung nach Art. 13 HMG beantragen. Dieses Arzneimittel wurde bereits im We want to apply for authorisation under Art. 13 TPA. The medicinal product in question has already been authorised abroad under the DCP and we now plan to have it authorised in additional countries using the RUP. If we wish to refer to the RUP in our application for authorisation in Switzerland under Art. 13 TPA, is it sufficient if we use the documents from the RUP or does Swissmedic need additional reports from the original, approved DCP to assess our application?
If an applicant is using a Repeat Use Procedure to extend the validity of a completed Mutual Recognition Procedure (MRP) to additional Member States, a complete, updated dossier has to be submitted for the Member States in question. This dossier is assessed by the national authority of the Reference Member State that conducted the initial MRP. Since this updated dossier contains all variations that have been approved since initial authorisation, the documents should meet the requirements for authorisation under Art. 13 TPA.
10. Is it possible to have orphan drugs authorised under Art. 13 TPA using the EU dossier as the reference dossier?
We are planning to submit an application for rapid authorisation in Switzerland of a chemical NAS. The substance has Orphan Drug Designation for the indication in question in Switzerland, the EU and the USA. The EMA has issued a positive opinion recommending authorisation, and the EU Commission is expected to approve the medicinal product soon. This raises the following questions:
a) Is it possible to have the product authorised under Art. 13 TPA using the EU dossier as the reference dossier?
Yes, a medicinal product with a new active substance or an indication extension of that product is eligible for a reduced assessment under Art. 13 TPA if the product has been classified and authorised as an orphan drug by the EMA Committee for Orphan Medicinal Products (COMP) or under the FDA Orphan Drug Act (see also Chapter 7.1 of guidance document Authorisation of human medicinal products under Art. 13 TPA HMV4).
b) How much time does submitting under Art. 13 TPA save?
The processing times for authorisation procedures under Art. 13 TPA are those set out in guidance document Time limits for authorisation applications HMV4 for the relevant application type. The procedure for applications under Art. 13 TPA will be shorter if no List of Questions has to be issued and the preliminary decision can be issued straight away.
11. What is the further procedure if an assessment under Art. 13 TPA is not “approved”?
Swissmedic does not “approve” assessments under Art. 13 TPA. Article 13 TPA states that Swissmedic will factor the results of foreign authorities’ assessments into its own review. Arts. 16–20 TPO specify which documents have to be submitted to Swissmedic to ensure that the Agency considers the results of assessments carried out abroad in its authorisation decision. Swissmedic examines whether the criteria set out in Arts. 16–20 TPO for the application of Art. 13 TPA have been fulfilled. If they have not, the applicant will be notified accordingly by means of a preliminary decision Rejection of application to apply Art. 13 TPA. The applicant then has the option of responding to the preliminary decision or of withdrawing its application. Swissmedic will examine the applicant’s response and decide if Art. 13 TPA can be applied. Unless informed otherwise, and assuming the application is not withdrawn, the Agency will review the documents under the regular procedure.
12. Is prior notification of submission (a letter of intent) needed for procedures under Art. 13 TPA?
No. When completing the form New authorisation of human medicinal products HMV4 or the form Variations and authorisation extensions HMV4, applicants should instead answer “yes” to the question of whether they want to request consideration of the results of foreign authorities’ assessments in accordance with Art. 13 TPA. The appropriate additional forms (e.g. form Information for application Art.13 TPA HMV4) should then be completed in full and returned to Swissmedic in accordance with guidance document Authorisation of human medicinal products under Art. 13 TPA HMV4.
13. Are oncologicals also eligible for a reduced assessment under Art. 13 TPA for medicinal products with a new active substance (NAS)?
Yes, provided the product has been granted orphan drug status by the EMA COMP or by the US FDA under the Orphan Drug Act and the product has been authorised by the EMA or FDA. In addition, an application for orphan drug status in Switzerland must already have been approved.
14. Are medicinal products with a new active substance (NAS) that have orphan drug status in Switzerland but not in the EU or USA, but which are nevertheless authorised in the EU and/or USA, eligible for Article 13 TPA?
No. Art. 13 TPA can only be applied to an application for authorisation of a medicinal product with a new active substance if the product in question has been granted orphan drug status by the EMA or FDA. In addition, the medicinal product must have been authorised by the EMA or FDA and an application for orphan drug status in Switzerland must already have been approved before the application for authorisation is submitted.
15. Are applications for the authorisation of biosimilars under Art. 13 TPA subject to additional requirements?
The criteria for applying Art. 13 TPA to applications for the authorisation of biosimilars are geared to the requirements in Chapter 6 of guidance document Authorisation of human medicinal products under Art. 13 TPA HMV4. If the criteria for applying Art. 13 TPA are not fulfilled, an interim decision to refuse application of Art. 13 TPA will be issued and the application for authorisation of the biosimilar will be reviewed in a normal authorisation procedure.
16. If Swissmedic has rejected an indication for a biosimilar, is it possible to submit this indication as an indication extension under Art. 13 TPA?
Yes. Since Swissmedic has rejected the indication in question, however, the reference authority’s Assessment Report will have to be evaluated. If this evaluation does not resolve the concerns that led to Swissmedic rejecting the indication, the Agency will inspect the basic documentation, but limit this inspection to its major concerns.
17. What happens if another authority issues a diverging decision while a procedure under Art. 13 TPA is still in progress?
If a foreign authority issues a diverging decision while a procedure under Art. 13 TPA is still in progress, Swissmedic must be notified of the decision and the associated Assessment Report must be submitted to the Agency. Conflicting decisions by foreign authorities constitute concerns. The diverging assessment result will feed into Swissmedic's ongoing review process.
18. Is the CHMP opinion sufficient for an application for authorisation under Art. 13 TPA or is it necessary to wait for the Commission Decision?
The CxMP / HMPC opinion can be submitted to Swissmedic for first submissions that are based on the EMA's Centralised Procedure.
19. By how much are fees reduced if an application is made to switch a regular authorisation procedure to Art. 13 TPA?
If there are parallel procedures, and Swissmedic permits the application of Art. 13 TPA, and the results of the foreign reference authority’s assessment provide a suitable basis, the flat-rate fees applicable to individual cases under Art. 10 FeeO-Swissmedic are reduced by 60%.
20. Do major objections in the foreign authority’s List of Questions count as major concerns?
If the foreign authority has authorised the medicinal product, it can be assumed that the case made by the applicant and/or the data it has supplied have been sufficient to resolve the major objections.
Questions and answers Art. 13 TPA (PDF, 312 kB, 01.11.2019)
https://www.swissmedic.ch/content/swissmedic/en/home/services/documents/faq-art-13.html