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)