Certification, authorisation, and inspection of tissue establishments
In the first step, the submitted application is checked for completeness. In case documents are missing or inadequate, the establishment will be notified to provide additional information. The administrative framework of the inspection procedure has to comply with the General Administrative Procedure Act (AVG).
Once the information of the application is complete, the inspector arranges an appointment for an on-site inspection with the tissue establishment. A written notice containing a rough agenda and a list of documents and information to be submitted follows this.
The on-site inspection starts with an opening discussion, in which the inspection team, management and key personnel take part. Once opened, the agenda will be consolidated and the objective and scope of the inspection clarified.
Next the tissue establishments presents itself including their quality assurance system, which already represents the beginning of the actual inspection. After having inspected the first documents, the inspection team goes on a tour in the facility. Afterwards the examination of relevant documents is continued.
At the end of the inspection, the leading inspector will summarise the observations in a final meeting for the management and key personnel and discuss the next steps of the procedure.
The observations and deviations will be summarised in an inspection report. The first version is sent to the tissue establishment for party hearing (AVG). The tissue establishment now has the opportunity to comment on this report and is obliged to submit an action plan including a timeline.
After evaluation of the company’s statements by the inspectors, the inspection result together with any authorisation or certification documents and the final report are sent to the Federal Office for Safety in Health Care (BASG).
The procedure has now been completed. (AVG)
If you have further questions about the inspection procedure, our instructions may help you (only available in German).
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.
Support authorisation holder/site
Registration examples are described in the guidance note eService inspections & surveillance (only available in German)
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Guidance note eService inspections & surveillance (only available in German)
The requirements of the Tissue Safety Act (including the associated ordinances) must be met: Tissue Banks, Tissue Collection Establishment and Tissue Vigilance Ordinance). You will find all the legal bases for downloading in the Legal Information System of the Federal Chancellery (www.ris.bka.gv.at).
Yes! When acting persons, activities and locations are contractually recorded. It should be noted that withdrawals are carried out under the responsibility and in accordance with the specifications of the withdrawal facility reported in accordance with § 19 GSG (this does not correspond to the mobile withdrawal team).
If a removal facility wishes to carry out removals by mobile removal teams in the future and has not yet carried out this activity, a change report in accordance with § 19 (2) GSG shall be submitted to the BASG.
Registration of procurement centers and tissue establishments has to be handled via eService inspections & surveillance. Your company has to file an application “GSG Authorisation / Certification” and the eService will guide you through the reporting process.
In order to register a procurement center or tissue establishment your company needs to be registered for the eService (see point “Electronic submission” above for further information).
You will be contacted by AGES Medizinmarktaufsicht, /Institut Inspektionen, Medizinprodukte & Hämovigilanz staff to make an appointment for the inspection of your cell/tissue equipment. The subsequent inspection will, based on the Tissue Safety Act, verify the suitability of your facility and identify any need for improvement before you can begin your activities after successful completion of the process (issuance of the permit or certificate).
Yes! However, depending on the type and scope of the change not every change is a reason for a re-examination during an inspection.
Examples for changes according to § 19 (2) GSG and § 22 (2) GSG:
- Procurement/processing/storage/distribution of new types of tissues or cells
- Significant changes in processing
- (One-off) imports of existing types of tissues or cells from third countries (see point 14. “Import” for further information)
- Changed operating locations regarding procurement/processing/storage/distribution of tissue and cells
- Authorisation / Certification change regarding the procurement/processing/storage/distribution of materials exhibiting positive infection serological diagnostics (exception: Your company already holds an authorization / certification for the procurement/processing/storage/distribution of materials exhibiting other positive infection serological)
Any change that must be reported shall result in an inspection and subsequently in the issue of an amended permit or certificate.
Yes, however, there must be a detailed, signed explanation by both partners of any potential risks to the woman or child and any cross-contamination of other tissues/cells must be prevented by appropriate measures during processing or storage.
If an IVF Institute wishes to carry out future treatments on patients who have been tested positive for infection serology (HBV, HCV, HIV) and has not yet offered this service, amendments must be submitted to the BASG in accordance with § 19 Para. 2 and § 22 Para. 2 GSG, as this is a new process.
The collection centre must verify the donor's identification and, in that case, obtain written confirmation from the donor of the origin of the semen donation. Care must be taken to ensure that transport specifications (duration, temperature, etc.) are set and that these are checked for compliance when the semen donation is accepted.
The requirements for premises and air quality are described in § 4 GBVO.
These GBVO requirements refer to incompletely closed systems or open (partial) process steps: "...when cells or tissues are exposed to the environment...". The requirements do not apply when a 'subsequent inactivation or sterilisation process' is carried out. The wording 'during processing' indicates the timing and frequency of the monitoring of requirements.
§ 4 Abs. 3 GBVO demands "...an air quality with a bacterial count and particle count according to stage A of the definition of the current guideline for good manufacturing practice, Annex 1 to Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use...with a background environment suitable for the processing of the cells or tissues concerned, which in terms of bacterial count and particle count at least corresponds to stage D...".
The following parameters for air quality in clean rooms and clean air systems (Class A or D) are defined in Annex 1 of the EU GMP Guidelines:
- Classification of rooms in accordance with EN ISO 14644-1 (point 4 of Annex 1 to the EU GMP Guidelines) - classification must be carried out at rest and in the operating state; for classification purposes, the methodology of EN/ISO 14644-1 defines both the minimum number of sampling locations and the sampling volume as well as the method for assessing the collected data. EN ISO 14644 refers to particle numbers. The limit values for air germ count determination in accordance with Annex 1 of the EU GMP Guidelines shall also be taken into account when classifying in the operational state.
- To demonstrate continued compliance with the specified cleanroom class, reclassifications shall be performed at appropriate intervals in accordance with EN ISO 14644-2.
- Ongoing air quality monitoring measurements should be carried out in the operational state. The monitoring points and frequency should be based on a formal risk analysis and the results obtained from the classification of the premises.
- Calibrated particle counters (certificate) and air samplers as well as sedimentation plates are to be used as measuring instruments.
- The limit values for particulates and airborne microbial counts are laid down in points 4 and 5 of Annex 1 to the EU GMP Guidelines.
Note: Surface disinfection can lead to surface-damaged organisms. These damaged germs are also found in the air and show a relatively long lag-phase. Therefore, when measuring airborne germs, care must be taken to determine the incubation conditions accordingly.
Documentation requirements: The documentation requirements for qualification shall comply with Annex 15 of the EU-GMP Guidelines. This requires a corresponding plan with acceptance criteria defined in advance and a report with a summary evaluation of the results for the functional and performance qualification. The documents are to be released by the responsible person.
Further information can be found in the following regulations:
- Annex 1, 15 of the EU-GMP Guideline
- VDI 2083-3
- ISO 14644-1,-2,-3
- Collection facilities that plan in future to collect ova intended for a third person must submit a change notification for the collection of cells and tissue to the Federal Office for Safety in Health Care (BASG). The application has to be handled via eService.
- Tissue banks which plan to store and distribute ova intended for a third person in the future and which do not yet hold an authorisation for the storage and distribution of ova must submit an application for an authorisation for a tissue bank (notification of change) to the BASG. The application has to be handled via eService.
Incoming applications will be ranked according to the date of their arrival at the BASG and, if possible, processed in this order. With regard to the possibility of carrying out preimplantation diagnostics, according to today's legal interpretation, no change notification is required. In the course of inspections by the BASG, the (outsourced) process is checked.
When do tissues/cells need to be marked with the Single European Code?
The requirements for this can be found in § 15a (1) and (2) GSG, which stipulate the following:
- Cells and tissues released for human applications shall be labelled by the tissue establishment with the unique European code in accordance with Annex 1 GSG.
- In other cases, where cells or tissues are released for circulation by the tissue establishment, at least the donor recognition sequence shall be documented in the accompanying documentation.
When is it not necessary to mark tissue/cells with the Uniform European Code?
The specification for this can be found in § 15a para. 3 GSG, which states the following:
"Paragraph 1 shall not apply to
- Germ cells from partner donations,
- Cells and tissues remaining in the same facility,
- cells or tissues imported from third countries, provided that they are imported through a tissue establishment with an authorisation to import from third countries located in the hospital where they are used, and
- for direct use in cells or tissues distributed directly to users."
In this context, Clause 2 is to be interpreted in such a way that the term "same establishment" refers to the whereabouts of cells/tissues within the same hospital (cf. also the definition in § 2 (36) GSG).
Transitional period for labelling with the uniform European code in accordance with Paragraph 37a(2), from when must the cells/tissues concerned be marked with the uniform European code?
For cells and tissues stored and released BEFORE 29.10.2016, no unique European coding is required if the unique traceability of the cells or tissues is otherwise ensured and the cells or tissues are distributed by 20.10.2021.
Cells and tissues processed or stored AFTER 29.10.2016 must be marked with the Single European Code from 29.04.2017 onwards.
What is your EU tissue establishment code?
This code consists of the ISO country code and the site code (for example, AT68XXXX).
Where can I find more information?
In which case do I need an import certificate in accordance with § 23 Abs. 6 GSG?
If your company plans to import tissues or cells from a third country to Austria, an import certificate is required. Please note that tissues and cells may only be imported into Austria from approved tissue banks. The importing tissue establishment (EGE) is entitled to carry out the new activity only after the inspection has been carried out and the procedure has been completed.
My company would like to buy / take over tissues and cells from the EU / EEA, do I need an import certificate in accordance with § 23 Abs. 6 GSG?
No! An import certificate is only required for imports from third countries. Attention, since 01.01.2021 the United Kingdom (with the exception of Northern Ireland) also counts as a third country.
My company has an import certificate according to § 23 Abs. 6 GSG, are changes in activities to be reported to the BASG?
Yes! Any change must be announced. However, not every change is a reason for a re-examination during an inspection.
Changes that affect the import certificate but do not entail inspection are, for example, changes to the contact details of the holder of a licence, or changes to the EU Member States where the imported tissues and cells are distributed.
Changes in third country suppliers must be checked by the BASG depending on their scope and can trigger an inspection procedure.
If an importing tissue establishment (EGE) plans to introduce a new cell or tissue type, it is imperative to notify the BASG before starting the new activity.
The EGE is entitled to carry out the new activity only after the inspection has been carried out and the procedure has been completed; fees will be charged if a new import certificate has to be issued or an inspection of an amendment has to be carried out. All fees can be found in the Ordinance of the Federal Office for Safety in Health Care on the Fee Tariff according to GESG.
Is the responsible person also liable for the activities of the procurement center?
No. The "responsible person" is not liable for the activities of the procurement center. According to § 9 Austrian Tissue Safety Act, the tasks of the responsible person are limited to those of the tissue bank.
Registration of a responsible person
Every tissue bank must have a "responsible person" at all times. Tissue banks must immediately report the responsible person as well as every change of this person (according to § 9 (2) Austrian Tissue Safety Act) immediately to the Federal Office for Safety in Health Care, providing proof of qualification (according to § 9 (4) Austrian Tissue Safety Act).
How many responsible persons must be reported and which qualifications should they have?
According to the Austrian Tissue Safety Act, every tissue bank must have at least one "responsible person" and this person must be registered (see § 9 (1) Austrian Tissue Safety Act). In principle, any person who meets the requirements can be registered, at the Federal Office Safety in Health Care, as a "responsible person" (requirements see § 9 (2) Austrian Tissue Safety Act).
Which tasks does the responsible person have?
According to the Austrian Tissue Safety Act, 'responsible person' must ensure that the human cells and tissues intended for human use are received, tested, processed, stored and distributed in accordance with the provisions of the Federal Act and the ordinances issued on its basis. The person must therefore be granted sufficient authority to fulfill this responsibility. Further regulations can be found in the Ordinance on Human Tissue Banks (e.g. § 2 (2) Ordinance on Human Tissue Banks, § 11 (5) Ordinance on Human Tissue Banks).
On 25.8.2023, a revision of Annex 1 of the GMP Guidelines will come into force, to which reference is also made in the Tissue Bank Ordinance (§ 4 Para. 3 GBVO). In this, under point. 2.3, a so-called Contamination Control Strategy (CCS) is to be implemented. This should include at least the following points for tissue banks, taking into account the operational requirements:
- Classification/qualification of clean rooms and equipment (see e.g. points 4.23ff).
- requalification (see e.g. point 4.32)
- Monitoring (see chapter 9)
Please note the slightly changed limit values in the individual tables.