Questions and answers regarding the application of the Administrative Ordinance (Art. 13, Therapeutic Products Act)

In the first version of the Administrative Ordinance (Instructions relating to the application of Art. 13, TPA) of 11 November 2008, Chapter 6.1.1, it was stated that following a first authorisation or a modification requiring approval in application of Art. 13, TPA, all subsequent modifications proved or prescribed by the reference authority must also be submitted and approved for Switzerland. In the new Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries (Art. 13, TPA) of 23 June 2010, this statement is no longer included.

a) Does this mean, therefore, that now that the new version is in force, it is no longer necessary to inform Swissmedic of modifications approved or prescribed by the reference authorities?

Yes. When Swissmedic issues the official authorisation, the authorisation procedure in application of Arts. 5a - 5d of the Ordinance on Medicinal Products (VAM) is concluded. Conditions imposed by the reference authority that have not yet been fulfilled at the point when the Agency issues a decision regarding authorisation are usually also imposed by Swissmedic. After the granting of the authorisation in Switzerland, decisions on the part of the reference authority regarding the fulfilment of such conditions must be submitted to the Agency within a reasonable time.

b) Does this also apply automatically to medicinal products that were authorised in application of the former Administrative Ordinance of 11 November 2008 relating to the application of Art. 13, TPA, and which include such conditions?

Yes. Under administrative law, the general rule is that a subsequent modification that is made with regard to the legal situation (in this case, the entry into force of Art. 5a et seq., VAM), is applied for decisions whose legal consequences have an effect for a specified or unspecified duration in the future.

Last updated on: 13.04.2011

In the Administrative Ordinance relating to the application of Art. 13, TPA of 11 November 2008, Chapter 6.1.1, it was stated that after an initial authorisation or a modification requiring approval in application of Art. 13, TPA, it was also necessary to continue submitting all relevant information regarding market surveillance in foreign countries (PSUR, PV plan). This statement has also been removed from the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries (Art. 13, TPA) of 23 June 2010.

Does this mean, therefore, that now that the new version is in force, it is sufficient to comply with mandatory reporting in application of with Art. 59, TPA and with Arts. 35 and 36, VAM, and that no additional information regarding market surveillance in foreign countries need be submitted?

Yes. Complying with mandatory reporting in application of Art. 59, TPA and Arts. 35 and 36, VAM is sufficient. The "Information regarding market surveillance in foreign countries" in question may, however, be subject to mandatory reporting under certain circumstances, in application of Art. 59, TPA. The routine submission of risk management plans or PSURs is nevertheless not required although they may be requested by Swissmedic at any time.

Last updated on: 13.04.2011

Yes. It is no longer necessary to inform Swissmedic on condition that the withdrawal from the market took place for purely financial reasons. If its distribution in foreign countries is restricted or halted on the basis of safety signals, however, reporting is mandatory in application of Art. 59, TPA and Arts. 35 and 36, VAM, i.e. the Agency must be informed that distribution has ceased. It is therefore possible that a product is withdrawn from the market in foreign countries, for purely financial reasons, without this affecting the authorisation of the product concerned in Switzerland.

Last updated on: 13.04.2011

Yes. An authorisation granted in application of Art. 13, TPA is a "normal authorisation", on whose basis it is possible to apply for a co-marketing authorisation.

Last updated on: 13.04.2011

Yes. Art. 5a, para. 1, VAM explicitly provides for this possibility ("If the applicant applies for (...) a modification to an authorisation for a medicinal product (...) for which the authorisation has already been granted in a country with a comparable regulatory authority for medicines, then the Agency takes the results of the relevant evaluation into consideration, (...)").

For a medicinal product with a new active substance (= NAS) and its extended indication (= EI), the provisions of Chapter 10 of the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries (Art. 13, TPA) apply. This states that NAS and their EI are usually assessed independently by Swissmedic. A reduced assessment is only possible in certain exceptional cases (orphan drugs, etc.).
If the medicinal product is one with a known active substance, however, an application for the results of the evaluations by foreign authorities when authorising major changes to be taken into consideration (incl. EI) is assessed with reference to Chapter 9 of the Administrative Ordinance, taking the evaluation results of the foreign authorities into consideration.

Last updated on: 13.04.2011

A reduced assessment in application of Art. 13, TPA is only possible for oncological medicinal products if the said medicines have a known active substance and if Swissmedic has already authorised the indications for the said active substance.
New oncological medicinal products or new indications for them are assessed independently by Swissmedic and the normal authorisation procedure is applied.
If the Agency completely waives its own scientific assessment, a reduction in the duration of the process of around one third is possible. This reduction in time cannot, however, be compared with the fast authorisation procedure as stated in Art. 5, VAM.

Last updated on: 13.04.2011

According to Art. 13, para. 1, AMZV, it is generally speaking necessary to draw up product information for all medicinal products. In some cases, however, Swissmedic may waive this requirement and designate medicinal products or groups thereof that require no product information (Art. 13, para. 3, AMZV). Based on Chapter 7.1 of the Administrative Ordinance relating to requirements for product information on human medicinal products of 30 August 2010 it is possible, for instance, for the requirement to be waived, on corresponding request, for herbal medicines of dispensing category D (with the exception of laxatives containing anthrachinone or products from dispensing category C containing St John's wort). Swissmedic nevertheless recommends that if product information has already been approved in the reference country, then the product information should also be submitted for Switzerland. For the Swiss product information it is not, however, necessary to refer to the foreign documentation.

Last updated on: 13.04.2011

Yes. The documentation submitted to Swissmedic must be identical to that based on which the reference authorities authorised the product (see the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries [Art. 13, TPA], Chapter 8.1).

Last updated on: 13.04.2011

The documentation submitted to Swissmedic must be identical to that based on which the reference authorities authorised the product or its modification (final version). Any approved modifications / additions that have taken place since the authorisation decision by the reference authority must be submitted to Swissmedic together with the application. This additional or replacement documentation must not be integrated within the documentation or the module concerned, but be submitted separately with the corresponding assessment report. The modifications must be mentioned in the accompanying letter, and a comparison showing them (former / current) must also be appended thereto (see the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries [Art. 13, TPA] of 23 June 2010, Chapter 8.1).

Last updated on: 13.04.2011

An application in accordance with Art. 13, TPA for the authorisation of medicinal products and that is based on an EU DCP authorisation primarily requires only the submission of the Assessment Report and the authorisation decision from the Reference Member State (RMS). The official decisions or authorisations issued by the Concerned Member States (CMS) need no longer be submitted.

This modification is valid as of November 2011.

Last updated on: 20.01.2012

Submitting a modification requiring approval in application of Art. 13, TPA is only possible if Swissmedic previously authorised the product in application of Art. 13, TPA and if an evaluation report for it from a foreign authority is available. For all other modifications requiring approval, authorisation taking into consideration Art. 13, TPA would result in no savings of time or efficiency.

Last updated on: 13.04.2011

As long as an authorisation procedure has not been completed, modifications submitted at a later point are considered to be a part of the current process. Depending on the additional resources this implies, it is possible that the processing will take longer and that a supplement to the fee will be applicable.

Last updated on: 13.04.2011

We wish to apply for the authorisation of a generic in application of Art. 13, TPA. The product has already been authorised abroad by means of the DCP, and is now to be authorised by means of the Repeat Use MRP in further countries. If we now have the product authorised in Switzerland in application of Art. 13, TPA and wish to refer to the MRP process in so doing, is it sufficient to use the documentation for the Repeat Use MRP, or are other reports from the successfully concluded DCP necessary in order to assess the application?

If a Repeat Use MRP is carried out (i.e. extending the validity of a completed MRP to other EU Member States), a complete, updated dossier must also be submitted for the new group of Member States, which is then evaluated by the authorities of the Reference Member State of the initial MRP. This updated dossier must also contain all approved modifications made since the first authorisation in order to ensure that these documents meet the requirements for authorisation in application of Art. 13, TPA.

Last updated on: 13.04.2011

We are planning the submission of an application for fast market authorisation in Switzerland (NAS, chemical substance). For the indication applied for, the substance has orphan drug designation in Switzerland, the EU and the USA. The EMA has recommended its authorisation (positive opinion), and authorisation by the EU Commission is expected to take place shortly. This raises several questions:

a) Is an authorisation for orphan drugs possible under Art. 13, TPA with the EU dossier as a reference?
Yes. A reduced assessment for NAS or an extension of its indication is - with the exception of oncological medicinal products - possible for products that have been categorised or authorised as "orphan drugs" by the EMA Committee for Orphan Medicinal Products (COMP) or by the FDA Orphan Drug Act (see Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries [Art. 13, TPA], Chapter 10.1).

b) How much time can be saved by a submission under Art. 13, TPA?
If the authorisation holder submits an application for the evaluations by foreign authorities to be taken into consideration in application of Art. 13, TPA and Arts. 5a - 5d, VAM, if the conditions stated in the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries (Article 13, TPA), are fulfilled, and if the Agency is thus able to base its decision regarding authorisation on the results of the evaluations by the reference authorities, then the target times stated in the guideline relating to time limits for authorisation applications of 9 December 2009 are reduced by one third, with the exception of the formal control phase of the application. Depending on the case, the overall fee applicable is reduced by one third if the above-mentioned conditions are fulfilled.

Last updated on: 13.04.2011

Is it sufficient to include a list on the "Status of application for authorisation in foreign countries" (in concrete terms, there is an ongoing submission in the USA and an authorisation for the same substance in difference dosage strengths in Japan (for a different licensee))?

For the Swissmedic authorisation procedure, no further documents from the authorisation procedure from other authorities need to be submitted in the case of a product authorised by the EMA Centralised Procedure, unless the applicant also has an evaluation decision by the FDA (including in the event of a rejection). For more details, reference can be made to the requirements in the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries (Article 13, TPA) (see in particular Chapter 8.3 and 8.9 and the information in Annex 1).

Last updated on: 13.04.2011

The applicant is informed of the decision by Swissmedic on this subject when the time limit for the List of Questions (LoQ) or the deadlines are communicated (see the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries [Art. 13, TPA] of 23 June 2010, Chapter 12.1).

Last updated on: 13.04.2011

Swissmedic does not "permit" an evaluation in application of Art. 13, TPA. The said article states that the evaluation results of foreign authorities are taken into consideration with regard to the evaluation by Swissmedic. The evaluation results by foreign authorities are always taken into consideration as long as they are submitted to Swissmedic. Arts 5a - 5d, VAM state which documents must be submitted to the Agency in order for it to be able to take the results of evaluations carried out in foreign countries into consideration when taking a decision regarding authorisation. Swissmedic must also, based on an analysis of the environment and background, examine whether or not there are grounds to carry out its own scientific assessment of the product in question. If such grounds exist (see the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries [Art. 13, TPA]), the Agency carries out its own scientific assessment (in certain cases limited to specific points), on the basis of the required documents, i.e. the scope is one of a perfectly normal first authorisation. For the applicant, however, this does not mean a completely different procedure: Swissmedic simply requests that certain parts of the dossier must be submitted in duplicate.

Last updated on: 13.04.2011

No. On the form "Application for authorisation / variation", it is necessary to state "yes" to the question asking whether the application will be submitted with the request to take the evaluation results of foreign authorities into consideration (in application of Art. 13, TPA) and to submit the other corresponding forms (e.g. checklist for formal control Art. 13, TPA in application of with provisions including those of the Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries [Art. 13, TPA] of 23 June 2010) completed in full.

Last updated on: 13.04.2011