Regulatory Affairs Services Provider in Austria
DDReg supports pharmaceutical, medical device, and biologics companies with regulatory affairs services in Austria. Our consultants manage submissions to BASG and coordinate technical evaluation through AGES MEA, across national authorisation procedures, EU mutual recognition, decentralised, and centralized procedures.
Austria's Regulatory Framework for Medicines and Medical Devices
Austria is an EU Member State. All marketing authorisations for medicinal products must comply with EU pharmaceutical legislation transposed into national law through the Austrian Medicines Act (Arzneimittelgesetz, AMG). The Federal Office for Safety in Health Care (BASG) is the national competent authority responsible for granting marketing authorisations, approving clinical trials, and overseeing market surveillance.
BASG is a subordinate authority of the Federal Ministry of Social Affairs, Health, Long-Term Care and Consumer Protection (BMASGPK). All operational and scientific tasks are carried out by the Austrian Medicines and Medical Devices Agency (AGES MEA), a business division of the Austrian Agency for Health and Food Safety (AGES). Employees of AGES MEA act on behalf of BASG when executing regulatory authority functions.
Austria participates fully in EU regulatory network procedures. AGES MEA provides scientific experts to EMA committees including CHMP, PRAC, and CVMP. Austria regularly acts as Reference Member State (RMS) in mutual recognition and decentralised procedures, with a documented record of timely, high-quality assessment reports.
Regulatory Authorities in Austria
| Authority | Role |
|---|---|
| BASG | National competent authority - grants marketing authorisations, approves clinical trials, issues GMP certificates, oversees pharmacovigilance and market surveillance |
| AGES MEA | Scientific and operational arm of BASG - conducts technical evaluations across specialised institutes (REGA, MRAT, QUAL, BPSA, CPAA, OMCL) |
| EMA | EU-level central authority - AGES MEA contributes scientific assessors to CHMP, PRAC, and CVMP; mandatory for biotechnology products and ATMPs |
| BMASGPK | Federal ministry with overall oversight responsibility for reimbursement, pricing policy, and health system legislation |
Regulatory Affairs Consulting Austria - Services Portfolio
DDReg's pharmaceutical regulatory affairs Austria practice covers the full product lifecycle across medicinal products, medical devices, biologics, and advanced therapy medicinal products.
-
Marketing Authorisation - Pharmaceuticals
-
Clinical Trials
-
Medical Device
-
Biologics and Advanced Therapy Medicinal Products (ATMPs)
-
Post-Approval Lifecycle Management
BASG Regulatory Support Austria - Submission Process
DDReg manages AGES regulatory services submissions through structured phases:
-
Pre-Submission Preparation
-
Dossier Preparation
-
AGES MEA Technical Evaluation
-
BASG Authorisation Decision
-
Post-Authorisation Compliance
Austria Regulatory Approval Timelines
Assessment timelines follow EU regulatory standards. Clock stops for applicant responses are excluded from the active assessment period:
| Procedure | Standard Assessment Period |
|---|---|
| National Procedure (pharmaceuticals) | 210 days (excl. clock stops) |
| Mutual Recognition Procedure - RMS phase | 90 days |
| Mutual Recognition Procedure - CMS phase | 90 days |
| Decentralised Procedure (DCP) | 210 days (RMS + CMS combined) |
| Centralised Procedure (EMA) | 210 days (CHMP opinion) |
| Type IA variation | 30 days (notification; immediate implementation) |
| Type IB variation | 30 days (assessment) |
| Type II variation | 60 days (major; up to 90 with extension) |
| Medical devices (Class I - CE marked) | Registration within days of EEA market placement |
| Medical devices (Class IIa/IIb - CE marked) | Notified body dependent; 3–9 months |
| Medical devices (Class III - CE marked) | Notified body dependent; 6–18 months |
Note: Clock stops for deficiency responses and outstanding GMP issues add to calendar time. DDReg's pre-submission quality review reduces clock-stop frequency.
DDReg's Expertise in Pharmaceutical Regulatory Affairs Austria
Our consultants understand how submissions flow between BASG sovereign authority and AGES MEA institute allocation. This knowledge informs dossier structure, scheduling of pre-submission meetings, and responses to REGA allocation scheme requirements.
DDReg manages Austria RMS procedures from day-zero meeting preparation through final national assessment report issuance. Our team coordinates CMDh breakout sessions and handles Concerned Member State question lists in MRP and DCP procedures.
Different product types receive evaluation from specific institutes: MRAT handles clinical assessment for standard chemical medicinal products; BPSA covers biologics, preclinical data, and statistical review; QUAL addresses pharmaceutical quality. DDReg aligns submission content with the expected evaluation focus of each assigned institute.
EU procedure dossiers submit in English, but Austrian national labelling, package leaflets, and BASG correspondence require German. DDReg provides German-language regulatory medical writing for Module 1 national documents and PIL preparation.
Austrian marketing authorisation does not automatically trigger reimbursement. DDReg coordinates the subsequent Heilmittelausschuss submission for green box (unrestricted reimbursement) or yellow box (physician-initiated) status, and supports Pricing Kommission applications where required.
Global Reach Explorer
Find Your Solution
Our Regulatory Affairs Consulting Services in Austria portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
