Parallelimport

1. Is it necessary to apply for an extension of the authorisation at a given time? If so, at what time?

No.

2. Are parallel imports subject to PSUR?

No, as long as the reference approval is upheld. If the reference marketing authorisation expires, the parallel importer must assume all pharmacovigilance obligations in full.

3. Is the parallel import licence for a proprietary medicinal product transferable?

No. In that case, a new application for a marketing authorisation for parallel imports shall be submitted.

4. A parallel import licence for a product covers all the import countries applied for. Does the addition of another importing country or package size require a change notification or a new marketing authorisation application?

Each country requires a separate application for authorisation and each country has its own authorisation number. Adding or omitting a package size, on the other hand, requires a change pursuant to § 24 AMG.

5. must applications be submitted in paper form in addition to the e-submission?

An additional paper version is not required.

6. is it possible to submit the licenses and company functions (wholesale license, manufacturing license) only once as a company main document?

No, each application must contain all the documents listed in § 10c AMG.

7. The original product information includes several strengths, but not all strengths are imported in parallel. Should the parallel import-package leaflet nevertheless contain the strengths not desired?

Yes, provided there are no inconsistencies. The texts for the outer packaging, primary packaging and, if applicable, package leaflet and SmPC may not contain any textual deviations from the labelling, if applicable, package leaflet and SmPC of the medicinal product authorised or registered in Austria, apart from company-specific information and information to avoid inconsistencies.

8. must the hazard symbol "Warning triangle" in the instructions for use and packaging be coloured?

No, in accordance with § 13 (1) of the Marking Ordinance 2008, the provisions regarding the colour of the hazard symbol do not have to be complied with.

9. Is it customary in Austria (as in Germany) for ready-to-sell pack sizes to be produced by cutting blisters (e.g. if the imported pack does not correspond to the number of blisters or tablets desired for the country of sale)?

Yes, the 'repackaging' of blisters in the context of repackaging is permitted under Community case-law. From the perspective of counterfeit medicines, however, we would like to point out that any perceptible manipulation may give rise to suspicion of counterfeiting, since it is not immediately apparent whether the manipulation took place in the context of authorised manufacture or in an unfair context.

10. Are there official requirements to the effect that imported, different package sizes must be shipped in their own folding boxes? Are bundles (e.g. 5 packs of 20 tablets each as 100 packs) common?

Specifications for bundled packaging can be found in Section 44 of the Labelling Ordinance 2008.

11. Company X distributes parallel import products in Denmark. The Danish authorities have imposed a requirement that imported packages which already have security features within the meaning of the Counterfeiting Directive (2011/62/EU) and which are lab

Such a condition is meaningful and welcome. However, the provisions of the Delegate Ordinance 2016/161/EU are only binding as of 9 February 2019.

12) How are the security features within the meaning of the Counterfeiting Directive to be displayed?

Information on the security features according to Directive 2011/62/EU can be found on the homepage of the European Commission, in particular the continuously updated and extended 'Questions and Answers' document on the Delegate Regulation 2016/161/EU. The Implementation plan of the EMA and the CMDh can also be found there. For general enquiries on the subject of "Serialisation and national implementation", the e-mail address info@serialisierung.at has been set up.

13. Where can you find national requirements, similar to the German "Besonderheitenliste"? In Germany, for example, a lactose warning must be affixed.

In principle, the provisions of the Labelling Ordinance 2008 apply, as do the Guideline on the packaging information, "Blue-box" Requirements and the Excipients Guideline. Product-specific labelling requirements can also be found in the approval notice.

14 The primary container (e.g. a syringe) is in a closed tray. Must the tray be opened to open the primary container or can the tray be labelled with the information required for the primary container?

No, cf. § 10c (6) AMG.

15 How is the BASG to be informed about the products we display at the EMA?

An informal notification is currently considered sufficient, cf. § 10c (4) AMG.

16 In the case of nationally authorised preparations, the Federal Office requires that the marketing authorisation holder of the Austrian reference authorisation be informed of the application at least one month before submission of the marketing authoris

See also § 10c (5) AMG. From the point of view of the BASG, this provision must be interpreted as meaning that the marketing authorisation holder must be informed at the latest at the same time as the application; from the point of view of the BASG, there is nothing to prevent an earlier communication, provided that it contains exactly the same information as the later application for approval.

17. Does the BASG also require a notification to this effect for centrally authorised products?

The marketing authorisation holder must also be informed in the idF, cf. § 10c (4) and (5) AMG.

18. Is a translation of the foreign package leaflet necessary? If so, which sections?

Yes, all product information must be available in German, cf. § 10c (3) Z12 AMG.

19. Is information proactively provided on changes to the reference authorisation (e.g. text change requirements)?

It is informed that something has changed in the reference authorization or the reference authorization has been revoked.

20. Are notifications of changes subject to authorisation even if they have already been issued for the original marketing authorisation holder?

Pursuant to Section 25a (2) of the German Medicines Act (AMG), holders for distribution in parallel imports are required to track changes to the reference product and notify the Federal Office thereof.

21 Which change notifications are generally subject to licensing for parallel imports?

Pursuant to Section 25a (2) of the German Medicines Act (AMG), holders for distribution in parallel imports are required to track changes to the reference product and notify the Federal Office thereof.

22. Are change notifications to be displayed only once a year, similar to EMA Annual updates, and are the costs covered by the annual fee?

No, the deadlines according to § 25a (2) AMG apply. The costs are covered by the annual fee.

23. Is there any proactive information on the part of the BASG in the case of measures to be implemented immediately in order to avert drug risks (e.g. text adaptation requirements)? Is a step-by-step plan or information officer required?

See § 75q (6) AMG.

24. Does the parallel importer need a pharmacovigilance system?

§ Section 10c(3) Z13 provides for a pharmacovigilance system for the licensing of parallel imports; the resulting obligations are laid down in Sections 75i et seq. of the German Medicines Act.

25. Can complaints and recalls from another Member State be dealt with centrally?

Yes, provided that such measures are dealt with by an actor established in the EEA.

26. The reference product is classified as a medical device in the exporting country, but as a medicinal product in the importing country. Can a parallel import licence be applied for for this product?

No. The European and national regulations stipulate that the reference product must have a valid marketing authorisation as a medicinal product in both the exporting and importing country.

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