FAQ - reportable qualified persons
Which key personnel are companies required to report immediately?
a. Companies which place medicinal products on the market (wholesalers)with an operating licence pursuant to §63 of the Austrian Medicines Act (AMG) as amended:
Changes to the GDP Responsible Person according to § 10 Arzneimittelbetriebsordnung 2009 (AMBO 2009) are not subject to notification. The fulfilment of the formal requirements for the function by the person appointed by the company is evaluated during inspections.
b. Companies with an operating licence according to § 63 of the Austrian Medicines Act (AMG) as amended, which manufacture and/or perform quality control on medicinal products (medicinal product manufacturers and quality control laboratories):
According to §7 (1) of the Arzneimittelbetriebsordnung 2009 (AMBO 2009), every manufacturer of medicinal products, every importer as well as every laboratory that controls medicinal products must have at least one Qualified Person permanently and continuously designated.
Therefore, changes with regard to the Qualified Person have to be submitted in advance or without undue delay in case of unforeseen changes in accordance with § 65 (3) of the Austrian Medicines Act via electronic submission in the eService (https://eservices.basg.gv.at/).
The following key personnel are not subject to notification:
- Head of Production: requirements according to §69 a AMG and §8 AMBO 2009
- Head of Quality Control : requirements according to §70 AMG and § 9 AMBO 2009 The fulfilment of the formal requirements for the function by the persons nominated by the company is evaluated during inspections by the competent authority.
c. Establishments with a licence according to the Tissue Safety Act:
According to § 9. (1) of the Tissue Safety Act (GSG), every tissue bank must have a "Responsible Person" at its disposal without interruption.
Therefore, changes regarding the responsible person according to § 9 (4) GSG via electronic submission in the eService(https://eservices.basg.gv.at/) are subject to notification in advance or without undue delay in case of unforeseen changes.
d. Blood establishments with a licence according to the Blood Safety Act::
According to § 5 (1) of the regulations on the operation and quality system of blood establishments(QS-VO Blut) any company which processes, stores or distributes blood or blood components intended exclusively for transfusion must continuously have a Responsible Person at its disposal who is responsible for ensuring that the processing, storage and distribution are carried out in accordance with the provisions of this Ordinance and Annex B of the (QS-VO Blood), as amended, and the state of the art in science and technology, and that blood and blood components meet the specifications laid out in Annex A of the Ordinance on medicinal products derived from human blood.
Additionally, according to § 7 (2) AMBO, any company that processes, stores or distributes human blood or blood components without any further manufacturing activities must have a Responsible Person at its disposal.
Therefore, according to § 5 (4) QS-VO Blut, changes with regard to the Responsible Person have to be submitted in advance or without undue delay in case of unforeseen changes via electronic submission in the eService (https://eservices.basg.gv.at/).
e. Licence holder:
Pursuant to § 56 (2) of the Austrian Medicines Act (AMG) as amended, the marketing authorisation holder or holder of a registration is obliged to commission a person with the necessary expertise and experience to responsibly perform the task of providing scientific information on the medicinal products placed on the market by the marketing authorisation holder (Information Officer) and to provide this person with the necessary authority to fulfil this task. The Federal Office for Safety in Health Care must be informed immediately of the appointment of the Information Officer and any changes to it.
For this reason, any changes with regard to the Information Officer must be reported in advance or immediately to inspektionen @basg.gv .at using the appropriate form (F_I66 - Form for reporting the Information Officer).
Which formal requirements are obligatory for the exercise of the function of the Qualified Person?
According to § 69a AMG, only persons with the necessary scientific professional training and appropriate practical training may be entrusted with the task of the Qualified Person. The personal requirements for the performance of the task of the Qualified Person are laid down in § 7 of the AMBO 2009.
These requirements are:
1) A level of education which corresponds to completed university studies of at least four years attested by a diploma in a contracting party to the EEA Agreement or in Switzerland and involving theoretical and practical training in one of the following disciplines: pharmacy, human medicine, dentistry, veterinary medicine, chemistry (incl. pharmaceutical chemistry and technology) or biology
2) The theoretical and practical instruction shall cover at least the following basic subjects : 1. applied physics, 2. general and inorganic chemistry, 3. organic chemistry, 4. analytical chemistry, 5. pharmaceutical chemistry, including analysis of medicinal products, 6. general and applied (medical) biochemistry, 7. physiology, 8. microbiology, 9. pharmacology, 10. pharmaceutical technology, 11. toxicology, and 12. pharmacognosy (medical aspects).
If the completed academic course does not cover all of the subjects listed, the missing knowledge can be acquired after successful completion of the academic course. The Federal Office for Safety in Health Care must be provided with clear evidence of the acquisition of the knowledge.
3) After completion of the academic course, at least two years' practical experience in one or more companies in a contracting party to the EEA Agreement or in Switzerland which are authorised to manufacture or control medicinal products. The activities have to encompass the qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing required to ensure the quality of medicinal products.
The performance of the relevant activity within the framework of pharmaceutical quality control must be proven beyond doubt to the Federal Office for Safety in Health Care by means of job references or job descriptions.
What must be taken into account for an application i for the issue of a confirmation of a Qualified Person in accordance with the Arzneimittelbetriebsordnung (AMBO 2009)?
Pursuant to § 7 (8) AMBO 2009, the authority has to examine, upon application, whether the applicant fulfils the formal requirements to perform the function of a Qualified Person.
For this purpose, processing fees are charged in accordance with the currently applicable fee tariff under the GESG.
An application for "Confirmation of a Qualified Person" is personal. It does not replace the immediate mandatory notification of a change to the Qualified Person by the company in accordance with § 65 (3) of the Austrian Medicines Act as amended.
The application is to be submitted using the application form (F_I220 Application for the issue of a Confirmation of a Qualified Person, Head of Production, Head of Quality Control according to AMBO 2009) to inspektionen @basg.gv.at.
Does a Qualified Person in accordance with § 7 AMBO 2009 have to be permanently employed? What is the lowest possible level of service?
On the basis of the relevant provisions of the AMBO 2009, from the perspective of the BASG it must be stated that the Qualified Person is a dependent employee of the company. It is precisely the required organisational integration into the company, including the obligation to follow instructions, in particular with regard to working hours, the lack of own operating resources etc., that draws a clear line to self-employment. The employment relationship of the Qualified Person has to be assessed according to the individual area of responsibility in the company and may deviate from a full-time employment relationship in individual cases. Exceptions are considered only appropriate for small companies in which, due to the activity to be carried out and the responsibility of the Qualified Person, an employment relationship of the type described would be disproportionate to the company . This must be demonstrated by the company in each individual case and decided by the BASG.
What must be taken into account for an application for the issue of a confirmation of a Head of Production or Head of Quality Control in accordance with the Arzneimittelbetriebsordnung (AMBO 2009)?
Upon application, the authority shall examine if the Head of Manufacture or the Head of Quality Control , have acquired the formal requirements for exercising the function outside a contracting party of the EEA or Switzerland, whether the relevant technical training or the qualified activity is equivalent to the requirements in § 8 para 2 or § 9 para 2 AMBO 2009.
Note: If the relevant professional training or qualified activity was acquired or carried out within a contracting party of the EEA or Switzerland, no application can be made for a preliminary examination of suitability. In this case, the procedure will be discontinued ex officio. Processing fees according to the currently applicable fee tariff according to the GESG are charged for each application.
The application must be submitted using the application form (F_I220 Application for issuance of a Confirmation of a Qualified Person, Head of Production, Head of Quality Control according to the AMBO 2009) to inspektionen @basg.gv.at
May responsibilities of a Qualified Person be delegated?
The release of a batch of medicinal products must be carried out by a Qualified Person. The Qualified Person may only delegate the tasks incumbent on him/her to another Qualified Person. See also Annex 16 to the EU-GMP (Certification by a Qualified Person and Batch Release) guidelines.
Can an external consultant take over activities of the Qualified Person?
No. In principle, the Federal Office for Safety in Health Care considers an employment relationship in the form of a contract of employment to be necessary (other forms of employment law such as a "contract for work and labour" or a "free service contract" are thus excluded).
Which formal requirements are obligatory for the performance of the function of the Responsible Person according to § 5 (4) QS-VO Blut?
The Responsible Person must have completed a course of study in human medicine, dentistry or veterinary medicine in a contracting party to the EEA Agreement or in Switzerland, or another course of study in the field of life sciences, or a course recognised as equivalent in the contracting party concerned, and on successful completion of that course must have completed at least two years' specialist employment in the EEA or in Switzerland in one or more establishments which were authorised to process, store and distribute blood or blood components during the period of that employment.