Austria Pharmaceutical Licensing

This record discusses only the Austrian compliance entry points for retail, wholesale and manufacturing/import of human medicinal products; it is not an explanation of financial licences. Public pharmacies, medicinal-product wholesale and manufacturing/import follow different legal pathways; incorporating a company or obtaining general business registration does not replace the relevant medicinal-product concession or BASG operating licence.

Federal legislation sets the main requirements for public pharmacies and medicinal-product businesses, but applications to establish a new public pharmacy are decided by the district administrative authority for the proposed location. Therefore, first confirm the competent authority and its procedural documents for the specific address. Apart from the statutory nationality and professional requirements for applicants for a public pharmacy concession, this review did not identify any foreign-ownership restriction that can safely be summarised as applying to all medicinal-product businesses.

— Retail: public pharmacy concession and review of pharmacy location/service needs.

— Wholesale: commercial wholesale qualification plus a BASG medicinal-product operating licence; general trade registration alone is not sufficient to operate.

— Manufacturing/import: assess the BASG operating licence, GMP, and import/product procedures separately.

BASG is the federal regulatory authority for medicinal-product marketing authorisations and medicinal-product business operating licences, and carries out inspections and supervision through the AGES medical market surveillance system. Its public medicinal-product business register covers businesses authorised under Article 63/63a of the Medicinal Products Act, but the register itself does not replace transaction-by-transaction verification of a counterparty’s actual purchasing eligibility.

Public pharmacies are governed by the federal Pharmacy Act, but concessions for new pharmacies are processed by the district administrative authority where the pharmacy is located. The Chamber of Pharmacists has a specific role in pharmacy partnership arrangements that meet the statutory requirements and in changes to those arrangements.

— BASG: medicinal-product business licences, GMP/GDP, product authorisations and import procedures.

— District administrative authority: location-specific decisions on concessions for new public pharmacies.

— Federal health authority: a separate import permit from this authority is required for imports containing narcotic drugs or psychotropic substances.

Austrian public pharmacies supply medicinal products to the public and must hold an operating concession. A concession for a new pharmacy is not an ordinary asset that a company may freely buy and sell: the law defines it as a personal right to operate and it is non-transferable. Applicants must also meet the statutory requirements concerning the pharmacy profession, management capability, reliability, health and German-language proficiency.

The location and service needs of a new pharmacy must be reviewed. The Pharmacy Act sets out, in certain circumstances, conditions relating to local doctors and doctors’ dispensing facilities; these are reviews applied by law according to the location and facts, and do not justify independently imposing nationwide fixed thresholds for floor area, distance or market share.

— An applicant for a public pharmacy concession must be an individual with the relevant pharmacist qualifications and management qualification.

— As a rule, the law requires the concession holder to operate as a sole proprietor; any partnership arrangement must comply with Article 12 of the Pharmacy Act, and the Chamber of Pharmacists reviews the relevant arrangements.

— Hospital pharmacies, doctors’ dispensing facilities, online/distance sales and veterinary medicines are subject to separate rules; this record does not treat them as automatic extensions of a public pharmacy concession.

The definition of a medicinal-product wholesaler links qualification under commercial law with a licence under Article 63 of the Medicinal Products Act. BASG expressly states that a business qualified under commercial law to wholesale medicinal products may operate as a medicinal-product wholesaler only if it also holds an Article 63 licence; general trade registration alone therefore does not cover medicinal-product wholesale.

The wholesale quality system should be managed in accordance with GDP. The company should ensure that its warehousing, receipt, dispatch, transport and record-keeping arrangements maintain quality and support traceability and recalls; supplying entities that are not legally eligible to purchase is not an issue that can be resolved by a WDA alone.

— Apply to BASG for an operating licence that matches the actual site and distribution scope.

— Personnel responsibilities, training and quality management should be documented internally; this review did not confirm uniform nationwide educational requirements for wholesale personnel in the official materials opened.

— Records of receipt, storage, transport and dispatch should support quality protection and traceability.

Businesses manufacturing, placing on the market or controlling medicinal products or medicinal products/active substances must obtain a BASG licence before commencing activities. BASG administers manufacturing/import licences (MIA) and wholesale authorisations (WDA) separately, and requires relevant applications and certifications to be submitted through its electronic inspection and supervision service.

GMP is a quality assurance standard for production processes and the production environment. Manufacturers, importers and medicinal-product control companies must continuously have at least one qualified person; for imports of products from third countries, BASG states that if the actual import site differs from the QP release site, separate corresponding operating licences or a compliant outsourced arrangement may be required.

— The manufacturing scope, site, equipment and quality activities must correspond to the scope of the BASG licence.

— Manufacturing/import businesses must appoint a QP and demonstrate that the statutory qualification requirements are met.

— A GMP licence does not automatically grant a blanket right to market products in Austria, wholesale, handle controlled substances or import across borders.

A public pharmacy concession is centred on an individual pharmacist who meets the requirements. Statutory application requirements include professional qualifications, five years of professional pharmaceutical activity after obtaining those qualifications to acquire the management qualification, reliability, health and the German-language knowledge needed to manage a pharmacy; the specific evidence and recognition requirements should be verified with the receiving authority and the legally designated professional body.

Manufacturers, importers and medicinal-product control companies must continuously have a QP. The statutory minimum route for a QP includes at least four years of relevant education recognised in the EEA or Switzerland, followed by at least two years engaged in activities related to statutory quality analysis and testing at an authorised medicinal-product/veterinary medicinal-product manufacturing or control business. There is no basis for stating that wholesalers must also appoint the same QP.

— Public pharmacy: the pharmacist concession holder and their statutory management qualification.

— Manufacturing/import/control: continuously maintain at least one QP.

— All relevant businesses: a sufficient number of competent and trained personnel, with responsibilities and authority documented in writing.

The location of a public pharmacy is not purely a commercial site-selection issue: a new concession requires an assessment of the statutory location and service needs. Publicly available materials do not support stating any particular floor area, distance between pharmacies or fit-out configuration as a uniform national threshold; the proposed address and the competent authority’s actual requirements should govern.

The facilities of medicinal product businesses must prevent deterioration in quality, contamination or cross-contamination. Medicinal products must be stored separately from other goods; applicable temperatures and humidity relevant to product quality must be measured and recorded regularly. Goods-receiving and dispatch areas, weather protection, segregation, cleaning and transport validation are also part of operational quality control.

— Retail: assess the location/service needs first, then put the premises in place.

— Wholesale: warehousing and transport must meet GDP quality and traceability controls.

— Manufacturing/import: the premises, equipment and logistics design must be consistent with the scope of the authorisation, GMP and QP release arrangements.

An application for a public pharmacy should be submitted to the district administrative authority responsible for the proposed location. The core application materials should cover the applicant’s personal qualifications, the proposed location and service needs; where a partnership is proposed, the partnership agreement and relevant arrangements required to assess control must also be submitted as required by law. Local authorities may request additional documents; confirm requirements with the authority for the relevant location.

Since 2020, applications for BASG authorisations/certifications for manufacturing, import and wholesale have in principle been submitted via the “Inspection and Surveillance” e-service. BASG publicly lists categories of business authorisation documents for placing medicinal products on the market, active substances, and the manufacture/control/import of medicinal products, and incorporates inspection findings into authorisation decisions.

— Define the business first: a public pharmacy, WDA, MIA, product marketing authorisation and import formalities cannot be combined into a single application.

— Before submitting electronically to BASG, confirm that the applicant entity/site has the required organisational information and system access credentials.

— After submission, cooperate with requests for additional information, inspections and corrective action; do not assume an authorisation will be granted while major deficiencies remain unresolved.

A statutory concession fee becomes payable when a public pharmacy concession is granted; the law sets its calculation basis as a proportion of contributions to the pharmacists’ salary fund, rather than as a uniform euro amount that can safely be stated here. BASG authorisation procedures are subject to its fee schedule; BASG FAQs indicate that the full fee may still be payable if an application is withdrawn or rejected after substantive review has been completed.

This review did not identify a uniform processing time applicable to all public pharmacy applications. For BASG medicinal-product business authorisations, official FAQs state that WDAs/MIAs generally do not specify an expiry date; this must not be confused with the initial five-year validity of a medicinal product marketing authorisation.

— Public pharmacy: fees are determined under the statutory calculation mechanism and the decision.

— WDA/MIA: confirm against BASG’s current fee schedule and the scope of the specific application; do not invent a uniform amount.

— Product marketing authorisation: initially five years; this is at product level, not the duration of a business authorisation.

Manufacturing must continuously comply with GMP, and wholesale must continuously comply with GDP. Businesses must maintain competent personnel, defined responsibilities, training, a quality system, storage and transport controls, and traceability records. BASG’s e-service also handles periodic inspections; the public register is updated monthly, but this does not replace a business’s responsibility to verify the qualifications of each trading partner transaction by transaction.

The fact that WDAs/MIAs generally have no expiry date does not mean they are not subject to ongoing oversight. Product marketing authorisation is a separate level: BASG states that an extension and reassessment must be applied for after the initial five-year period.

— Manufacturing/import: maintain QP coverage, GMP compliance, the quality system and inspection readiness.

— Wholesale: maintain GDP compliance, qualified storage and transport, and customer/supplier qualification controls.

— Retail: continue to meet the personal and operational conditions of the public pharmacy concession; no uniform renewal cycle has been verified.

A public pharmacy concession is a personal right to operate and is expressly non-transferable by law. Pharmacy partnership arrangements or changes to them are subject to review by the Chamber of Pharmacists; therefore, before acquiring a company or assets, or leasing premises for a pharmacy business, do not assume that the existing concession can automatically be taken over.

A BASG authorisation is required for material changes to manufacturing, placing on the market or control, particularly changes to the type/scope/location of activities, or to the nature, size, equipment or use of premises and technical equipment, where these may affect the product or the manufacturing/distribution plan. The law provides for a decision generally within 30 days of receipt of the application, extendable to 90 days in exceptional cases; this is not a uniform time limit for all authorisation applications.

— Public pharmacy: first assess whether a new concession application is required and whether the partnership arrangements need review.

— Businesses holding an MIA/WDA: before relocating, adding a process/dosage form, changing quality-relevant premises or making a significant equipment change, assess the change-authorisation requirement under Article 65.

The full implications of an equity or change-of-control transaction for a WDA/MIA are not answered uniformly in the official materials reviewed for this guide; confirm each case with BASG and the competent company/pharmacy authorities.

BASG assesses product marketing authorisations for efficacy, safety and quality; these are distinct from retail, wholesale or manufacturing business authorisations. An initial product marketing authorisation is generally valid for five years, after which an extension must be applied for from BASG; product changes must also be approved. Authorisation for business premises cannot replace a product marketing authorisation.

Applications or notifications under the Medicinal Products Import Act are handled by BASG and submitted through its electronic portal. Eligible applicants are limited to public pharmacies, hospital pharmacies or businesses holding a medicinal product/blood product distribution authorisation in any EEA contracting party. Imports from third countries generally require an import authorisation, while transfers within the EEA generally require notification; the specific requirements still depend on the goods, origin and applicable exceptions.

Imports of medicinal products containing narcotic drugs or psychotropic substances require, in addition to the Medicinal Products Import Act requirements, an import authorisation for controlled substances from the federal health authority. Do not state that a BASG business authorisation or medicinal product marketing authorisation automatically covers this separate authorisation.

— Product: marketing authorisations, extensions and variations are handled through BASG product procedures.

— Import: first verify the country of origin/dispatch, EEA or third-country route, customs classification, and whether an import authorisation or notification is required.

— Controlled drugs: separately check the controlled-substances rules and authorisation from the health authority.