FAQ - reportable qualified persons

Which specialists are required to report immediately by the company?

a. Businesses with an operating licence pursuant to Section 63 of the German Medicines Act (AMG) as amended which place drugs on the market (drug wholesalers):

Changes to the Qualified 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 within the scope of an inspection.

b. Companies with an operating licence according to § 63 of the German Medicines Act (AMG) as amended, which produce and/or control drugs (drug manufacturers and control laboratories):

According to Section 7 (1) of the Arzneimittelbetriebsordnung 2009 (AMBO 2009), every business of a manufacturer of medicinal products, every business of an importer as well as every business that controls medicinal products must have at least one qualified person permanently and uninterruptedly.

For this reason, changes with regard to the qualified person are subject to notification in advance or without delay for the respective operating site in accordance with Section 65 (3) of the German Medicines Act via electronic submission in the eService (https://eservices.basg.gv.at/).

The following persons in managerial or responsible positions are not subject to reporting to the authorities: - Head of production: requirements according to Section 69 a AMG and Section 8 AMBO 2009 - Head of control laboratory: requirements according to Section 70 AMG and Section 9 AMBO 2009 The fulfilment of the formal requirements for the function by the persons nominated by the company is evaluated in an inspection.

c. Establishments with a licence according to the Tissue Safety Act:

According to § 9. paragraph 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 para. 4 GSG via electronic submission in the eService(https://eservices.basg.gv.at/) are subject to notification in advance or without delay for the respective operating site.

d. Establishments with a licence according to the Blood Safety Act:

According to § 5 paragraph 1 of the regulations on the operation and quality system of blood establishments(QS-VO Blut) in conjunction with § 7 paragraph. 2 AMBO, every establishment which processes, stores or distributes blood or blood components intended exclusively for transfusion must have a responsible person at its disposal without interruption 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 Ordinance on medicinal products derived from human blood(QS-VO Blood), as amended, and the state of the art in science and technology, and that blood and blood components meet the specifications in Annex A of the Ordinance on medicinal products derived from human blood.

Therefore, according to § 5 para. 4 QS-VO Blood, changes regarding the responsible person via electronic submission in the eService(https://eservices.basg.gv.at/) are subject to notification for the respective operating site in advance or without delay.

e. Licence holder:

Pursuant to Section 56 (2) of the German 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 inspektionenbasg.gvat 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 competent 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 or biology

2) The theoretical and practical instruction shall cover at least the following basic subjects : 1. experimental 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 even after successfully completing the course. The Federal Office for Safety in Health Care must be provided with clear evidence of the acquisition of the knowledge (for further information see the website of the University of Vienna):

3) Oncompletion of the training course, at least two years' experience in one or more undertakings in a contracting party to the EEA Agreement or in Switzerland whichhave been grantedan authorisation to manufacture or control medicinal products shall be required in the field of qualitative analysis of medicinal products , quantitative analysis of the active ingredients and the tests and trials necessary 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 when an application is made for the issue of a confirmation Qualified Person in accordance with the Arzneimittelbetriebsordnung (AMBO 2009)?

Pursuant to Section 7 (8) AMBO 2009, the authority has to examine, upon application, whether the applicant fulfils the formal requirements to perform the function of a competent person.

For this purpose, processing fees are charged in accordance with the currently applicable fee tariff under the GESG.

An application for "confirmation of competent person" is personal. It does not replace the immediate mandatory notification of a competent person by the company in accordance with Section 65 (3) of the German Medicines Act as amended.

The application is to be submitted using the application form (F_I220 Application for the issue of a confirmation Competent Person, Head of Production, Control Laboratory Manager according to the German Drug Operation Regulations 2009) to inspektionenbasg.gvat.

Does a competent person § 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, it must be stated from the perspective of the BASG that the qualified person must normally be a dependent employee of the company covered by the AMBO 2009. 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 only seem appropriate for very 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 organization. This must be demonstrated by the company in each individual case and decided by the BASG.

What must be taken into account when an application is made for the issue of a confirmation to the head of the production or control laboratory in accordance with the Arzneimittelbetriebsordnung (AMBO 2009)?

Upon application, the authority shall examine for the head of manufacture or the head of the control laboratory, if they 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. CAVE: 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 under the GESG are charged for each application.

The application must be submitted using the application form (F_I220 Application for issuance of a confirmation Expert, head of production, control laboratory manager according to the 2009 Medicinal Products Ordinance) to inspektionenbasg.gvat

How can the competent person be represented?

The release of a batch of medicinal products must be carried out by a competent 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 competent person for a company?

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 para. 4 QS-VO Blood?

The responsible person must have completed a course of study in human medicine, dentistry or veterinary medicine in a Contracting Party to the Agreement on the European Economic Area 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 work in the European Economic Area 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 work.