Good Manufacturing Practice (GMP) refers to the guidelines for quality assurance of production processes and environments in the production of drugs, active ingredients and medical devices. Reference: EMA GMP

For blood establishments and establishments processing, storing or distributing blood or blood components intended exclusively for transfusion, see Licensing and inspection of blood establishments

Good Distribution Practice (GDP) is understood to mean the guidelines for quality assurance in the context of the distribution of medicinal products. Reference: EMA GDP

The list gives an overview of the procedures in progress at the Institute of Surveillance / AGES MEA, which are subject to the Austrian Drug Law (AMG) or the Austrian Blood Safety Law (BSG). It shows all orders, both applied for and periodic procedures, which concern national companies.

The list is arranged alphabetically according to applicants or sites and shows

• whether a procedure is being actively processed or whether (re)action is required by our customers (clock stop);
• the respective order status, from the date of the order to the assignment to the inspector or the inspection team, the execution of the inspection as well as the sending of the initial report to the party belonging to the party and the respective date of completion by the institute (two months in retrospect).

The list is updated monthly on the 10th of each month.

The in the following listed applications in the sense of the Austrian Medicines Act, Austrian Blood Safety Act and Austrian Tissue Safety Act are mandatory starting from 06.04.2020 in accordance with electronic submission regulation (EEVO) over the eService inspections & surveillance:

• authorisations and certificate confirmations
• inspection of a design qualification
• third country (re)inspections
• (de-) registration of brokers
• (de-) registration of responsible persons / Qualified Persons
• official certificate

From this point on, periodic inspections according to Austrian Medicines Act (GMDP, PV), Austrian Blood Safety Act and Austrian Tissue Safety Act are also handled by eService inspections & surveillance. Inspections in the area of narcotic drugs and psychotropic substances should also be handled by eService inspections & surveillance if possible. At present, deviations are possible in individual cases after consultation.

The new regulatory framework for veterinary medicinal products (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022:

• Integration of EudraGMDP into the Organization Management Service (OMS) of EMA.
• Extension of the two following modules in EudraGMDP related to veterinary medicinal products:
  • Wholesale Distribution Authorization (WDA).
  • Active Pharmaceutical Ingredients Registration (API-Reg)

The most important change is the integration of EudraGMDP into OMS. As of January 28, 2022, national authorities will no longer be able to enter organizational data (organization or facility name and location) into EudraGMDP. Instead, the relevant organizational or company names and location data, including the legally (company register) recorded address of the manufacturer/importer/wholesaler/pharmaceutical intermediary, will be transferred from OMS. In the related documents for human and veterinary medicinal products as well as clinical investigational medicinal products and active substances (incl. operating license for manufacturing or wholesale, GMDP certificates,) the OMS data will also be transferred.

As of January 28, 2022, the national authorities can only make entries in EudraGMDP or create documents in this system if the relevant organizational data of the establishments are recorded in OMS. This concerns the following cases:

• First-time creation of documents in EudraGMDP, following an initial application (e.g. new manufacturing or wholesale permit).
• Renewal of existing documents (e.g. new version of the operating license, GMDP certificates issued in the course of a periodic inspection).

For this reason, it is necessary that all organizations that currently appear in EudraGMDP (whose permits / GMDP certificates are available in EudraGMDP), including manufacturers inside and outside the EU, importers and wholesalers of human and veterinary medicines, are registered in OMS.

Comprehensive information on OMS can be found here:

• OMS website
• Video tutorial: Overview of OMS
• Webinar for industry: Introduction to OMS services and activities

If you have any questions, please contact EMA at vetchange.programme@ema.europa.eu.