Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Lead author
Approver
Signature: ON FILE
Signature: ON FILE
Supersedes:
Date: 06-JAN-12
Date: 06-JAN-12
n/a
TrackWise record no.: 2897
1. Purpose
To enable the processing of financial documents for certificates in a consistent way.
To describe the procedure for processing financial documents for certificates, i.e. preparation and
approval of sales orders.
2. Scope
This SOP applies to the Compliance and Inspection Sector only, and should be read in conjunction with
the documents listed in section 6.
3. Responsibilities
It is the responsibility of the each Head of Sector to ensure that this procedure is adhered to within
his/her own sector. The responsibility for the execution of a particular part of this procedure is
identified in the right-hand column of section 9.
European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.
6. Related documents
Rules for implementation of Council Regulation (EC) No 297/95 on fees payable to the European
Medicines Agency and other measures, as amended:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/03/WC500104381.pdf
Rules for the implementation of the Financial Regulation applicable to the budget of the European
Medicines Agency, as amended: Doc.-Ref.: EMA/MB/281870/2010
7. Definitions
Certificates database
P-CI
Page 2/5
1. Record request
no
2. Correct
administrative
fee applied?
yes
no
3. Billing
address
correct?
yes
5. Search database
for issued certificates
7. Allocate to correct
conglomerate in certificates
database
no
9. Sales
order
correct?
yes
END
Page 3/5
9. Procedure
Step
Action
Responsibility
Certificates
(according to SOP/INSP/2000).
assistant
Certificates
request.
assistant
Certificates
database.
assistant
Go to step 2.
3
Certificates
assistant
Certificates
the address stated on the request, correct the billing address in the
assistant
database.
Go to step 3.
4
Once the company and administrative fee have been checked and
Certificates
are correct, create the master, issue the certificate and record the
assistant
Search the database for issued certificates in the time period for
Initiating agent
Produce the financial report from the database for the quarter for
Initiating agent
which invoices are prepared. This report will filter all information
relevant for the financial procedure, i.e.: company details and
customer number, number of sets requested and total
administrative fee to be invoiced for the issued certificates.
7
Initiating agent
Page 4/5
Step
8
Action
Responsibility
Initiating agent
Verifying officer
fee on the sales order are correct by checking the sales order
against the information contained in the financial report from the
database.
If the information on the sales order is correct, send hard copies to
initiating agent and proceed with step 10.
If the information on the sales order is incorrect, proceed with step
9.1.
9.1
Verifying officer
Initiating agent
Initiating agent
10. Records
When the processing of financial documents for certificates is completed and approved, the retention of
the hard copy will be the responsibility of the P-CI Sector. Retention time according to Business
Classification Scheme.
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