§ 32 (1) No. 7 of the Medicines Act: The sponsor shall make available the sufficiently characterized and labelled investigational medicinal product, the manufacture of which has been carried out in accordance with a company regulation in accordance with Section 62 or, if the trial substance was not manufactured in Austria, in any case in accordance with the internationally recognized standards, in accordance with para. 3.

Identification Ordinance 2008

Labelling of investigational medicinal products § 50

In addition to ICH GCP (Art. 2.12) and the AMBO 2009 (§ 1/4 and § 2/8), the GMP principles and guidelines including annexes (including Annex 13) of the European Commission are to be used for interpretation.

AMBO 2009

§ 1 (4) The provisions on medicinal products contained in this Ordinance shall also apply to investigational medicinal products unless there are special provisions for investigational medicinal products.

§ 2 (8) Good Manufacturing Practice: that part of pharmaceutical quality assurance which ensures that medicinal products are manufactured and controlled consistently in accordance with quality standards corresponding to their intended use; the generally accepted scientific principles and requirements contained in the guidelines and appendices referred to in § 36(1) shall be used to interpret the principles and guidelines of good manufacturing practice;

§ 36 (1) The European Commission's Guide to Good Manufacturing Practice for Medicinal Products and Investigational Medicinal Products and its Annexes is published in Volume 4 of the Regulation on Medicinal Products in the European Community.

According to § 50 (2) 9 of the Labelling Ordinance, the indication of the duration of usability cannot be listed in an accompanying document.

In the case of the use of authorised or registered medicinal specialities in unchanged packaging, the indication of the expiry date is part of the labelling (see § 15 of the Ordinance on Labelling). In the case of the use of approved or registered medicinal specialities which are intended for use in clinical trials after additional manufacturing measures (e.g. repackaging), the provisions of § 50 (1) to (6) shall apply in full.

Changes to the labelling of investigational medicinal products during the clinical trial at the trial site are only possible during the period of use.

In accordance with the AMBO 2009 § 29 (10), it is permissible for the manufacturer to instruct a technically suitable person in an investigating body to subsequently change the expiry date of investigational medicinal products, provided that these investigational medicinal products are intended exclusively for use in this investigating body and it is ensured that this is done in accordance with Good Manufacturing Practice.

According to § 50 (6) of the Labelling Ordinance, if the period of usability is to be subsequently extended, an additional label shall be affixed to the primary packaging and, if used, to the outer packaging showing the new expiry date or the date of retesting and the batch designation. The label can be used to cover the earlier date, but not the existing batch designation.

According to the Marking Ordinance §50 (7), special markings on the primary packaging and outer packaging in accordance with paras. 2 to 6 may be dispensed with insofar as the concept of clinical trials permits and insofar as investigational medicinal products are approved or registered medicinal specialities which are intended for use in clinical trials without additional manufacturing measures. The information referred to in paragraph 1 may also be included in an accompanying document.

Pursuant to § 50 (1), the sponsor of a clinical trial shall ensure that the labelling of the investigational medicinal products provides sufficient protection for the persons concerned, enables traceability and identification of the medicinal product and the trial, and ensures proper use of the medicinal product.

It is therefore not absolutely necessary to affix an adhesive label identifying the merchandise as an investigational product, provided that the identification of the clinical trial (reference to the clinical trial, trial plan code, EudraCT number, etc.) is ensured by an accompanying document supplementing the label.

The requirements of the labelling regulation §50 (7) regarding approved and registered investigational medicinal products are to be interpreted exclusively for preparations registered in Austria.

The EU Directive "Guidance on IMPS and other medicinal products used in Clinical Trials", published in Volume 10 of the Notice to Applicants, explicitly provides (under points 3.1 and 3.2) that products with a marketing authorisation in a (preferably EU) country other than the Member State may be used as NIMPs in clinical trials.

May medicinal products with a marketing authorisation outside Austria be placed on the Austrian market in accordance with the AMG?

If the definition of a NIMP applies to a medicinal speciality used in the context of a clinical trial with EU/EEA approval and the definition of an investigational medicinal product according to AMG §2a (14) is to be excluded, the provisions of the Medicinal Products Import Act apply to the application in the context of the clinical trial if the medicinal product is not approved in Austria, i.e. import or shipment to Austria is possible after an import permit or import notification if a technical justification exists. The medicinal product may be placed on the market in the form approved abroad without any further labelling requirements.

Which requirements apply to the labelling (language) or to the information to be provided to the patient?

If the marking of the NIMP is not made out in German, an accompanying text should be provided in German if it is handed directly to the examinee.

No exemptions (reduced information on labels) for push-through packagings are mentioned in § 50 of the Labelling Ordinance, therefore the regulations from Annex 13 point 30 are to be used. Pursuant to Section 28 (2) AMG, GCP Art. 2.12 and AMBO 2009 (Section 1/4 and Section 2/8), the GMP principles and guidelines including Annexes (including Annex 13) of the European Commission are to be used for interpretation.