Information Officer §74a AMG

The Information Officer according to §74a of the German Medicines Act (AMG) is responsible for coordinating and monitoring the information and marketing activities of a pharmaceutical company. He is responsible for ensuring that all activities in this area comply with legal requirements and that no misleading information reaches the public. In this way, he plays a decisive role in ensuring that information about medicinal products is correct, transparent, and compliant with regulations.

Tasks of an Information Officer

The goal of an Information Officer is to ensure that information and advertising about a drug comply with legal requirements. In order to do this, an information officer has to perform a variety of tasks:

  • He or she must safely navigate the medical/scientific environment to apply all relevant guidelines
  • He is responsible for ensuring that the labeling, package insert, specialized information, and advertising for a product are consistent with its approval or registration
  • He/she must prepare expert information, directions for use, mandatory texts, and red or yellow list entries
  • He is responsible for up-to-date directions for use and expert information as well as mandatory texts
  • He must always be informed about relevant changes in national and EU-wide regulations, laws, and deadlines and implement them accordingly.
  • Coordinate with the relevant authorities
  • He must conduct training to sensitize sales and marketing personnel to applicable legal regulations

Legal Framework

Section 74a of the German Medicines Act (AMG) stipulates that every pharmaceutical entrepreneur who markets finished medicinal products must appoint a person with the necessary expertise and the reliability required to perform his or her duties to responsibly perform the task of providing scientific information about the medicinal products (information officer).
The main task of the information officer is primarily oriented towards not violating §8 para. 1 no. 2 of the German AMG – i.e. to ensure that medicinal products or active ingredients are not “provided with misleading designation, indication or presentation.” (AMG §8 para.1 no. 2)

In Austria, Section 56 of the Medicines Act contains a similar provision:

“The marketing authorization holder or holder of a registration is obliged to appoint a person who has 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 authorization holder (information officer) and to provide him or her with the necessary powers to perform these tasks.” (Medicines Act § 56)

In both countries, the pharmaceutical entrepreneur must notify the information officer and any change in this position to the competent authority in advance.
Since the legal framework may vary from nation to nation, it is important that both companies and the information officer are aware of the relevant regulations in their jurisdiction.

Requirements and Prerequisites for an information officer

Those who want to pursue a career as an information officer should have some requirements and knowledge:

  • Education and expertise: Although this is not mandatory, an Information Officer is usually required to have a degree with a pharmaceutical or medical focus. In-depth knowledge of the legal basis for human and veterinary medicine, personal liability in the event of misconduct, various marketing and sales strategies, as well as basic product knowledge and basic medical knowledge are also usually required.
  • Soft Skills: An Information Officer should work in a structured and scientific manner, as well as have an accurate and reliable work ethic. In addition, good project management, teamwork, communication skills, assertiveness and negotiation skills are important for a career as an Information Officer.

 

Do you have a vacancy for an Information Officer or would you like to develop your career in this direction? Feel free to contact us – we will find the perfect match to suit your individual circumstances.

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