image
DE_SN_01_REG_2015_xxxx
Seite 1 von 3
xx.xx.20xx
Union Format for Registration
1
of Manufacturer, Importer or Distrib-
utor of Active Substances to be used as Starting Materials in Medic-
inal Products for Human Use
1. Registration number
2. Name or corporate name of registrant
3. Permanent or Legal address of registrant
4. Address(es) of site(s) where registered activities take place
(All relevant sites should be listed if not covered by separate registrations)
5. National legal basis of registration
6. Name of responsible officer of the competent authority of the member state validating
the registration
2
7.
Signature
2
8. Date
This registration form is valid only when presented with all pages. The authenticity of this
registration form may be verified in the Union database or with the validating authority.
The registration holder referred to in section 2 shall communicate annually to the competent
authority an inventory of the changes which have taken place as regards the information pro-
vided in this registration form. Any changes that may have an impact on the quality or safety
of the listed active substances must be notified immediately.
1
Without prejudice to any further national legislative requirements
2
Optional
LANDESDIREKTION SACHSEN
09105 Chemnitz

DE_SN_01_REG_year_xxxx
Seite 2 von 3
SCOPE OF REGISTRATION
Name and address of the site:
1. MANUFACTURING OPERATIONS
Active Substance(s):
A
Manufacture of Active Substance by Chemical Synthesis
1. Manufacture of active substance intermediates
2. Manufacture of crude active substance
3. Salt formation / Purification steps : <free text> (e.g. crystallisation)
4. Other <free text>
B
Extraction of Active Substance from Natural Sources
1. Extraction of substance from plant source
2. Extraction of substance from animal source
3. Extraction of substance from human source
4. Extraction of substance from mineral source
5. Modification of extracted substance <specify source 1,2,3,4>
6. Purification of extracted substance <specify source 1,2,3,4 >
7. Other <free text>
C
Manufacture of Active Substance using Biological Processes
1. Fermentation
2. Cell Culture <specify cell type> (e.g. mammalian / bacterial )
3. Isolation / Purification
4. Modification
5. Other <free text>
D
Manufacture of sterile active substance (note Parts A, B & C, to be completed as
applicable)
1. Aseptically prepared
2. Terminally sterilised
E
General Finishing Steps
1. Physical processing steps < specify > (e.g. drying, milling / micronisation, sieving)
2. Primary Packaging (enclosing / sealing the active substance within a packaging mate-
rial which is in direct contact with the substance)
3. Secondary Packaging (placing the sealed primary package within an outer packaging
material or container. This also includes any labelling of the material which could be

DE_SN_01_REG_year_xxxx
Seite 3 von 3
used for identification or traceability (lot numbering) of the active substance)
4. Other <free text> (for operations not described above)
F
Quality Control Testing
This section should be completed only if any parts of sections A, B, C, D, E are completed
1. Physical / Chemical testing
2. Microbiological testing (excluding sterility testing)
3. Microbiological testing (including sterility testing)
4. Biological Testing
2. IMPORTATION AND DISTRIBUTION OPERATIONS
A
Importation
(list all imported active substances together with details of the relevant manufacturers, and
where applicable, distributors)
Active substance
3
rd
country manufacturer
(name & address)
Distributor
(name & address)
B
Distribution
Active substance(s) (list all active substances for which distribution operations apply)
Any restrictions or clarifying remarks related to the scope of these registered operations
.................................................................................................................................................
.................................................................................................................................................
Name of responsible officer of the competent authority of the member state validating the
registration
1
Signature
3
3
Optional