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

including 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)