Application for paediatric extension of a Supplementary Protection Certificate for a Medicinal Product

Introduction

Electronic application for paediatric extension of a Supplementary Protection Certificate for a Medicinal Product

Here you can fill in the application form for a paediatric extension of a Supplementary Protection Certificate in Denmark.

The application fee for a paediatric extension of a Supplementary Protection Certificate is 2.500,00 DKK.

Before we start the examination of your application you need to at least provide or submit the following:

  • Name and address of all applicants
  • Application or registration number of the Supplementary Protection Certificate, for which the extension is applied
  • Provide the product and Tradename you want to protect
  • Number and title of Basic Patent
  • Documentation showing marketing authorisations issued for all EC member states
  • Copy of the granted Supplementary Protection Certificate
  • Copy of the statement indicating compliance with an agreed completed paediatric investigation plan

Did you remember everything?
Please see our Guidelines for Patenter. Please note that our Guidelines only exists in Danish.

Before submitting your application you will be able to revise your application. We will examine your application as soon as we have received it and registered the payment for your application.

You can correct your application by using the tabs. In case you need to attach further documents to the application, you may do so under the tab Remarks.

Your application is filed when you have chosen one of the possible payment methods and you will receive a receipt under the tab Receipt. A copy of the receipt may be downloaded with a copy of your application in pdf.

You are welcome to contact our service desk before you send your application. Please note that the application cannot be changed after it has been sent.

 
Guidance
Applicant may be a company or a private person. You must fill in the CVR-No if applicant is a registered company in Denmark. We send our communication to the first applicant in case of more than one applicant. In case you require someone else to receive our communication you can indicate that under the tab Remarks.
Applicant(s)
Applicant 1
Company Optional
Company registration number (CVR) Optional
First name Optional
Last name Optional
Address

Postal Code / City
 
Country
Telephone
Telefax Optional
Email
Representative
Indicate your reference number, if applicable
 
The Application
Relation to a Supplementary Protection Certificate for a Medicinal Product
The application is filed together with an application for a Supplementary Protection Certificate for a Medicinal Product
The application refers to extension of application for Supplementary Protection Certificate filed with the Danish Patent and Trademark Office
The application refers to extension of Supplementary Protection Certificate registration
Product
The product you want to protect
Add the product you want to protect (300 characters)
Add the Trade Name (50 characters)
Basic Patent
Add the number of the Basic Patent (20 characters)
Title of Basic Patent
Add the title of the Basic Patent (100 characters)
Declarations
Valid Marketing Authorisation enclosed
Indicate whether Marketing Athorisation/s to place the product on the market in all EC member states, updated with statement/s indicating compliance with an agreed and completed Paediatric Investigation Plan, PIP is enclosed
Orphan Drug designation
The product you want to protect is not classified as a medicinal product for rare diseases - Orphan Drug designation
One-Year Extension of data exclusivity
No request for a one-year extension of data exclusivity for the marketing authorisation for the product applied for, on the basis of the paediatric indication, has been filed
 
Language in which your application is filed
You may file your application in Danish or English. The Danish Patent and Trademark Office can demand a translation into Danish or English if the application is filed in another language
Filed in Danish
Filed in English
Filed in another language
Language in which your application is examined
You may receive our communication in Danish or English
The examination is requested in Danish
The examination is requested in English
 
Guidance
spcext.files_intro
Enclosures
Type of Document File Format Size of file
No files added
 
Guidance
Remarks to the application
Remarks to the application
Additional enclosures
Type of Document File Format Size of file
No files added