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CISPLATIN "EBEWE" 0.5MG/ML CONCENTRATE FOR INFUSION

Active substance: CISPLATIN

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Guidance Notes for completion of Application Form for WHO Export Statement
of Licensing Status of Pharmaceutical (s) from the MHRA
Section of the Application form
1
Date of Application
2
Applicants own Reference Number

Notes on Completion
Self explanatory
As required to identify the certificate on
return

3.1

Application Details

Name, address and phone number of the
applicant for the certificate. This is the
address to which the certificate will be
returned and will not necessarily be the same
as the name of the exporter appearing on the
certificate.

3.2

Invoice Details

This is the address to which the invoice will
be sent. If the name and address are the
same as those of the applicant, this section
can be left as blank.

4
Importing country for which the
certificate is required
5
Type of Service Required
6
Number of Certificates Required

7

Language Required

8
Details of the Product Requiring a
Statement

9
The Name of the Product
9.1
The Dosage Form of the Product
9.2
The Marketing Authorisation Number
of the Product
9.3
If the Product does not have a
Marketing Authorisation
9.4
Active Ingredients involved in the
Formulation of the Product

MHRA/Export Certificates (SLS)/ November 2010

Self explanatory
Self explanatory
Up to 1 original and 2 copies of the
certificate will be supplied at no additional
cost to the fee for the selected service.
Additional Certificates are available at a cost
of £33 per certificate. If no indication is given
to the amount required on the application
form then only one certificate will be
supplied.
Self explanatory – note that if no language is
indicated on the application, then certificate
will be processed in English.
Indicate here the number of page attached
containing the additional information and the
number of products for which the Statement
of Licensing Status is required. It should be
noted that the maximum number of products
on each certificate is ten. Any further
products will merit a further application.
As per product Licence
As per product Licence
Self explanatory
Self explanatory
All the active ingredients involved in the
manufacture of the product should be listed,
with their respective unit dose.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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