Standard operating procedure

Title: Handling of financial procedure for certificates

Status: PUBLIC

Document no.: SOP/INSP/2007

Lead author

Approver

Effective date: 09-JAN-12

Name: Stefanos Voutselas

Name: Fergus Sweeney

Review date: 09-JAN-15

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.

4. Changes since last revision

New SOP.

5. Documents needed for this SOP

Certificates finance list (itemised bill) generated by certificates database

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom

Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416
E-mail info@ema.europa.eu Website www.ema.europa.eu

An agency of the European Union

European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

6. Related documents

Council Regulation (EEC) No 297/95 articles 3 and 5, as amended:

ec.europa.eu/health/files/eudralex/vol-1/reg.../reg_1995_297_en.pdf

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

Financial Regulation (FR) of the European Medicines Agency, as amended: Doc.-Ref.:

EMA/MB/216485/2009

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

SOP/INSP/2000 Certificates of medicinal products.

7. Definitions
Certificates database

Certificates database of the European Medicines Agency

P-CI

Compliance and Inspections Sector in the Patient Health Protection Unit

Standard operating procedure PUBLIC

SOP/INSP/2007, 09-JAN-12

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8. Process map(s)/ flow chart(s)

START

1. Record request

no

2. Correct
administrative
fee applied?

2.1 Correct administrative

fee level in database

yes

no

3. Billing
address
correct?

3.1 Correct billing address

in database

yes

4. Create master, issue certificate

and record issue date in
database

5. Search database
for issued certificates

6. Produce financial report for

issued certificates

7. Allocate to correct
conglomerate in certificates
database

8. Complete sales order and

send it off for verification

9.1 Send sales order back

to Initiating Agent

9.2 Correct sales order

no

9. Sales
order
correct?

yes

10. File financial report

END

Standard operating procedure PUBLIC

SOP/INSP/2007, 09-JAN-12

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9. Procedure
Step

Action

Responsibility

Operational initiation of sales order

1

Record certificates request received in Microsoft outlook inbox

Certificates

(according to SOP/INSP/2000).

assistant

The database automatically calculates the administrative fee and

imports the address of the requesting company from the request
form.
Operational verification of sales order
2

Check whether correct administrative fee level is applied per

Certificates

request.

assistant

If administrative fee is correct, proceed with step 3.

If administrative fee is wrong, proceed with step 2.1.
2.1

If the recorded administrative fee is wrong, correct it in the

Certificates

database.

assistant

Go to step 2.
3

Check whether the billing address recorded in the database

Certificates

corresponds to the company address on the request.

assistant

If billing address is correct, proceed with step 4.

If billing address is wrong, proceed with step 3.1.
3.1

If there is a discrepancy between the billing address recorded and

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

issue date in the database.

Financial initiation of sales order
5

Search the database for issued certificates in the time period for

Initiating agent

which invoices are prepared, i.e. for every quarter of year.

6

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

Allocation of the certificate to the right conglomerate is done

Initiating agent

automatically by the certificates database.

Standard operating procedure PUBLIC

SOP/INSP/2007, 09-JAN-12

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Step
8

Action

Responsibility

Certificates database completes automatically the data in the

Initiating agent

financial database to create the sales orders. Sales orders

processed into the SAP workflow. A hard copy of the sales orders
report, with a dated sticker, is sent to verifying officer.
Financial verification of sales order
9

Check if the company details and the amount of the administrative

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

If there are mistakes on the sales order, reject it in the financial

Verifying officer

database, inform the initiating agent about what information is

incorrect and send it back to the initiating agent for correction.
Continue with step 9.2.
9.2

According to the comments from the verifying officer, correct the

Initiating agent

sales order. After correction, send it back to the verifying officer.

Go to step 9.
10

File the hardcopies of the financial report in the designated folder

Initiating agent

located in the initiating agents office.

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.

Standard operating procedure PUBLIC

SOP/INSP/2007, 09-JAN-12

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