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Austria Drug Product Registration

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Austria Drug Product Registration

Austria Drug Product Registration

Ministry of Health

European Centre for Disease Prevention and Control

Ministry of Health Website

http://www.bmg.gv.at/

Regulatory Authority 

BASG – Federal Office for Safety in Health Care

AGES- Austrian Agency for Health and Food Safety

Link for Regulatory Authority

https://www.basg.gv.at/en/about-us

http://www.ages.at/

Local Authorised Representative Required

Yes

License Validity

5 years

Fees

https://www.basg.gv.at/fileadmin/redakteure/02_Ueber_Uns/Geb%C3%BChrentarif/Fees_01.01.2024.pdf

Dossier Format 

Common Technical Document (CTD)

Austria Drug Product Registration Process

One of the primary responsibilities of the Federal Office for Safety in Health Care (BASG) is the authorization of drugs based on the Austrian Drug Law. The professionals review the medication’s quality, safety, and efficacy during the approval procedure. Only when the advantages of a pharmaceutical product outweigh the hazards and the current risk-benefit profile is proportional can it be authorized. Initially, an authorization is given for a duration of five years. 

After that, the medicine will be re-examined based on a fresh application that is filed to the BASG. The extension happens if the outcome is favorable. Modifications to pharmaceuticals must also be approved by the BASG before being submitted. Austrian government’s healthcare spending clearly showcases good market for drug/medicinal products in the country. 

The primary causes of the rising demand for pharmaceutical items in Austria are the country’s aging population and rising health consciousness. Manufacturers are required to get a Market Authorization authorized by the Austrian Agency for Health and Food Safety prior to marketing medical items locally. 

Any new pharmaceutical product must be registered through a Marketing Authorization Application (MAA) in accordance with Directive 2001/83/EC, which requires the following steps to be taken: 

  1.  New Chemical Entity (NCE) Article 8(3)
  2. Article 10 for biological medicines that are hybrid, generic, and comparable

Furthermore, with the UK being the third nation after March 30, 2019, the Market Authorization Holder (MAH) must fulfil all requirements set out by the European Union (EU) and the European Economic Area (EEA).

The marketing authorization holder is allowed to distribute medicinal products only after obtaining official approval from the authorities. In Austria, the legal foundation for this approval is the Medicinal Products Act (MPA) of 1984, which has undergone several amendments over time.

Three Different Procedures to obtain Marketing Authorization

There are three different procedures to obtain a marketing authorisation of Generic and medicinal product in Austria:

1. National Procedure

 The MPA establishes the exclusive national authorization process, applicable solely to medicinal products seeking approval for use in Austria. Within AGES, the agency AGES PharmMed assesses the application, and the marketing authorization is granted by the BASG.

  1. Mutual recognition/Decentralized Procedure

When a drug is to be approved in more than one EU nation, the authorization process must be followed. The mutual recognition of marketing authorizations from Member States forms the foundation of this approach. For an authorization that is currently in place in one of the Member States, the mutual recognition method ought to be utilized. 

Only if none of the Member States has any other comparable authorization does the decentralized process apply. The decision about which Member State to approve a medical product rest with the applicant. The authorization application must be positively approved by each of the participating Member States as a fundamental need. Once the process is finished, each Member State issues a nationwide marketing authorization.

  1. Centralized Procedure

The authorization process is required for biotechnological pharmaceuticals, pharmaceuticals for innovative therapeutics, some veterinary medications, orphan medicines, and new compounds for specific uses.

In this process, the EMA, which has its headquarters in London, UK, conducts the review instead of the national authority. The European Commission grants an EU authorization to each and every Member State in accordance with the EMA evaluation.

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