FAQ - reportable qualified persons

Which qualified persons must be notified immediately by the company?

a. Companies with an authorisation in accordance with § 63 of the Austrian Medicines Act (AMG) as amended which place medicinal products on the market (pharmaceutical wholesalers):

Changes in the qualified person according to § 10 Arzneimittelbetriebsordnung 2009 (AMBO 2009) do not have to be reported. The fulfilment of the formal functional requirements by the person designated by the establishment is evaluated during an inspection.

b. Companies with an authorisation in accordance with § 63 of the Austrian Medicines Act (AMG) as amended which manufacture and/or control medicinal products (pharmaceutical manufacturers and control laboratories):

According to § 7 Para. 1 Arzneimittelbetriebsordnung 2009 (AMBO 2009), every establishment of a manufacturer of medicinal products, every establishment of an importer and every establishment that controls medicinal products must have at least one qualified person permanently and without interruption.

For this reason, changes relating to the qualified person pursuant to § 65 (3) AMG must be reported in advance or without delay using the appropriate form.

The following persons in managerial or responsible positions are not required to report to the authority: - Head of production: Requirements according to § 69 a AMG and § 8 AMBO 2009 - Head of control laboratory: Requirements according to § 70 AMG and § 9 AMBO 2009 The fulfilment of formal functional requirements by the persons designated by the company is evaluated during an inspection.

c. Establishments with a licence in accordance with the Tissue Safety Act:

According to § 9. Abs. 1 Gewebesicherheitsgesetz (GSG) each tissue bank must have a "responsible person" at its disposal without interruption.

Therefore changes concerning the responsible person according to § 9 Abs. 4 GSG are to be reported in advance or immediately by means of the corresponding form.

d. establishments licensed in accordance with the Blood Safety Act:

According to § 5 para. 1 of the regulations governing the operation and quality system of blood establishments (QS-VO Blut), every establishment 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 Regulation and Annex B of the Regulation concerning medicinal products derived from human blood, as amended, and the state of the art in science and technology, and that blood and blood components comply with the specifications set out in Annex A of the Regulation concerning medicinal products derived from human blood.

Therefore, changes regarding the responsible person must be reported in advance or immediately using the appropriate form.

e. marketing authorisation holder:

Pursuant to Section 56 (2) of the Austrian Medicines Act (Arzneimittelgesetz - AMG) as amended, the marketing authorisation holder or holder of a registration is obliged to instruct a person with the required expertise and experience to assume responsibility for the task of providing scientific information on medicinal products placed on the market by the marketing authorisation holder (information officer) and to provide such person with the necessary powers to perform these tasks. The appointment of the Information Officer and any changes thereto shall be brought to the attention of the Federal Office for Safety in Health Care without delay.

Therefore, changes concerning the Information Officer must be reported in advance or without delay using the appropriate form.

Which formal requirements are mandatory for the performance of the function of a competent person?

According to § 69a AMG, only persons with the required scientific professional background and corresponding practical training may be entrusted with the task of a qualified person. The personal prerequisites for carrying out the activities of a competent person are laid down in § 7 of the AMBO 2009.

These prerequisites are:

  1. A level of academic education of at least four years attested by a diploma in a Contracting Party to the EEA or in Switzerland, comprising theoretical and practical instruction in one of the following fields: 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 drug analysis, 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 training course does not cover all of the above subjects, the missing knowledge can also be acquired after successfully completing the training course. The acquisition of the knowledge must be proven beyond doubt to the Federal Office for Safety in Health Care (further information on the website of the University of Vienna):
  3. After completion of the training, at least two years' service in one or more undertakings in a contracting party to the EEA or in Switzerland authorised to manufacture or control medicinal products in the field of qualitative analysis of medicinal products, quantitative analysis of active ingredients and the tests and trials necessary to ensure the quality of medicinal products is required.

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 has to be considered if an application is made for the issuance of a Confirmation of Qualified Person according to the Pharmaceutical Plant Regulations (AMBO 2009)?

Pursuant to § 7 para. 8 AMBO 2009, the authority must, upon application, check whether the applicant fulfils the formal requirements for exercising the function of a qualified person.

Processing costs are charged in accordance with the currently applicable fee tariff in accordance with the GESG.

A request for "Confirmation of a Qualified Person" is person-related. It does not replace the immediate obligatory notification of a competent person according to § 65 para. 3 AMG as amended by the company.

Here you can find the application form (F_I220 Application for issuance of a confirmation Expert person, Head of production, Head of control laboratory according to the Pharmaceutical Plant Regulations 2009).

What has to be considered if an application is made for the issuance of a confirmation of Head of Production or Head of Control Laboratory in accordance with the Pharmaceutical Plant Regulations (AMBO 2009)?

Upon application by the head of production or the head of the control laboratory, if they have acquired the formal requirements to perform the function outside a contracting party to the EEA or Switzerland, the authority shall check whether the relevant technical training or the qualified activity is to be regarded as equivalent to the requirements in § 8 (2) or § 9 (2) AMBO 2009. Processing costs are charged in accordance with the currently applicable fee tariff in accordance with the GESG. CAVE: If the relevant technical training or qualified activity has been acquired or carried out within a contracting party to the EEA or Switzerland, no application can be made for a preliminary aptitude test. In such a case, the proceedings shall be terminated ex officio. Processing costs according to the currently valid fee tariff according to GESG will be charged.

Here you can find the application form (F_I220 Application for issuance of a confirmation Qualified Person, Head of production, Head of control laboratory according to the Pharmaceutical Plant Regulations 2009).

How can the qualified person be represented?

The release of a batch of medicinal products must be carried out by a qualified person. The qualified person may only delegate his duties to another qualified person. See Annex 16 to the EU-GMP Guidelines.

Can an external consultant take over activities of a qualified person for a company?

No. In principle, an employee relationship is required from the point of view of the Federal Office for Safety in Health Care (other service law forms such as a "contract for work" or a "free service contract" are thus excluded). Depending on the scope of production, the employment relationship can also exist as part-time or part-time employment.

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