Authorisations & Certificates

Manufacturing & Import Authorisation

Manufacture and import of the following investigational medicinal products for clinical trial phases I-III
in accordance with § 13 par. 1 and § 72 par. 1 AMG (German drug law);
as well as medicinal products in accordance with § 1 Arzneimittelhärtefallverordnung (German law), (Compassionate use):

Manufacturing of non-sterile products:

• hard shell capsules, soft shell capsules
• Overencapsulation of solid oral dosage forms
• liquid dosage forms for exterior application
• liquid dosage forms for interior application
• semi-solid dosage forms
• manufacture of herbal products

Primary packaging (Refilling, Packaging and Labelling):

In addition to the above-mentioned dosage forms also the primary packaging of:

• Tablets
• Soft shell capsules
• Chewing gums
• Other solid dosage form (powder & granulates)

Secondary and tertiary packaging:

• All dosage forms

Batch certification:

• Sterile und non-sterile products
• Immunological products
• Biotechnological products

With exception of products listed in § 15 par. 3 und 3a AMG (German drug law)!

Manufacturing of Human medicinal products (commercial products) in accordance with § 13 par. 1 AMG (German drug law):

Secondary, tertiary packaging & batch certification:

• All dosage forms

Import and batch certification of medicinal products:

• Sterile products
• Non sterile products
• Biological medicinal products
• Commerical market products from non-EU countries used as IMPs in clinical studies
• Importation of intermediate which goes further processing

Wholesale Distributor Authorisation (Human & Veterinary medicinal products)

Authorised activities:

• Sourcing
• Storage
• Shipping & Delivery
• Export

Medicinal products with special requirements

• Medicinal products in accordance with Art. 83 of Directive 2001/83/EC
• Medicinal products in accordance with Art. 67 of Directive 2001/82/EC
  • Narcotics and psychotropic substances
  • Blood-derivatives medicinal products
  • Immunological drugs
• Medicinal gases
• Pharmaceuticals requiring an uninterrupted cold chain (documentation during storage and transport at low temperatures)