Establishment of a pharmaceutical company in Germany / EU / US

We establish your pharmaceutical company

When founding a pharmaceutical company in Germany, specifically, in the EU, or in the US, in general numerous steps, regulations, and legislation must be observed. Especially when placing drugs on the German market, the requirements to serve as pharmaceutical entrepreneur (pU) according to § 67 paragraph 1 of the German Drug Law (AMG) have to be fulfilled.

The company must also appoint a step-by-step plan officer, in accordance with Section 63a of the AMG, who has the necessary reliability and expertise to carry out the activity. Furthermore, an information officer, according to § 74a AMG with the legally required expertise and reliability must be notified. The following documents must be enclosed with the notification of the pharmaceutical company: a current excerpt from the commercial register, the nomination of the information and step-by-step plan officer (including proof of professional qualification, a certificate of good conduct of document type O, not older than 3 months, a copy of the policy on the required pharmaceutical liability insurance, information on the procurement of the medicinal products (e.g. contract manufacturer, co-distribution right, possibility of own production, etc.).

A pharmaceutical company must comply with Good Manufacturing Practice (GMP) guidelines, the Arznemittelgesetz (AMG), and the Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV) and establish a quality management system (QMS). The decisive factor is whether you and your company manufacture medicinal products yourself (manufacturer’s permit in accordance with § 13 AMG), only want to distribute medicinal products (§ 52a AMG wholesale permit) or want to import medicinal products from third countries (import permit in accordance with § 72 AMG). The application at the competent authority for the respective permit has to me made before starting the activity. An import permit can only be granted if, analogous to the manufacturing permit, certain personnel and material requirements are fulfilled (described in more detail in §§ 13-20a AMG).

When placing medical devices on the market, on the other hand, requirements such as CE marking in accordance with the General Safety and Performance Requirements for Medical Devices and the prescribed conformity assessment procedure must be fulfilled. Likewise, a QMS must be in place and personnel functions, such as those of a medical device safety officer, must be assigned in accordance with the Medical Devices Act (MPG).

Likewise, in the case of food supplements and cosmetics, the corresponding legal requirements must be met by the company.

We support you with individual tasks such as the recruitment of personnel or obtaining official approvals– or we can manage the entire establishment of a company in Germany, in another EU country or in the US. Feel free to contact us!