Parallelimport
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.
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.
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.
11. 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.
12. 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.
15. In case of nat. approved preparations,the Federal Office requires that holder of AT Reference authorisation at 1 month before the submission of application for authorisation,applicant shall be informed of application.Can the appl. be filed earlier?
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.
19. 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 AMG, holders for distribution in parallel imports are required to track changes to the reference product and notify the Federal Office thereof.
25. 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.
