Guidance for companies

Guidelines for companies 

On 1 June 2022, a new fee structure was introduced in the pharmaceutical area, including new fees for veterinary variations.

Applications for new marketing authorisations and subsequent extensions

The fee for applications for new marketing authorisations comprises all strengths and pharmaceutical forms in a procedure regardless of procedure type. A separate fee is charged for any subsequent applications for extension of the authorisation, e.g. with new pharmaceutical forms or strengths. 

Surcharges

To ensure the fee corresponds as much as possible to the actual review performed, a fee has been set for the review of an application for a new marketing authorisation based on a standard assessment equivalent to the documentation of quality, safety and efficacy usually submitted for the type of application in question. However, the standard fee does not cover the assessment of bioequivalence or any extra assessments of a non-clinical, clinical or veterinary clinical nature. In this case a surcharge is added to the standard fee.  

Duplicate applications

Duplicate applications are applications for new marketing authorisations in which the applicant can refer to the review of an application for which a full fee was charged, and where the dossier (modules 1, 2, 3, 4 and 5), the legal basis and the time line are the same.  
The requirement for the time line to be same implies, for example, that an application for new marketing authorisation cannot be considered duplicate if the application is submitted after marketing authorisation has been granted for the initial reviewed application. As a result, the Danish Medicines Agency will charge a full fee.

Denmark as Reference Member State (MRP-RMS) including RUP (Repeat Use Procedure for human medicines) and SRP (Subsequent Recognition Procedure for veterinary medicines)

1) Procedure with full updating 

 This fee is charged for applications requiring a full update of the assessment report prior to the procedure itself. 

2) Procedure with administrative updating 

This fee is charged for applications requiring only a minor administrative update of the assessment report prior to the procedure itself. 

3) Day zero procedure

This fee is charged for applications requiring no update to the assessment report and where the procedure is a “Day zero procedure”. 

Fees for applications requiring an update of the assessment report will generally be charged in connection with updating of the assessment report.  

Variations and extensions

Applications for variations and extensions are subject to a fee per case/procedure, regardless of the number of changes or medicinal products in it. However, the fee amount for variations will vary depending on whether the application is a single or a grouped application. 

Concepts and definitions in the field of variations

”Administrative” means applications for variations categorised as administrative in accordance with the European Commission’s categories of variations. In the case of human medicines, this corresponds to classifications beginning with the letter ”A” in the guidelines from the European Commission1.  In the case of veterinary medicines, this corresponds to classifications beginning with the letters “A” and “E”, respectively, in the European Commission’s implementing regulation establishing a list of variations not requiring assessment and the EMA/CMDv Guidance on the details of the classification of variations requiring assessment.

”Quality” means applications for variations categorised as changes to the medicinal product’s quality or PMF/ VAMF in accordance with the European Commission’s categories of variations. In the case of human medicines, this corresponds to classifications beginning with the letters ”B” and “D” in the guidelines from the European Commission1. In the case of veterinary medicines, this corresponds to classifications beginning with the letters ”B” and ”D” and ”F” and ”H”, respectively, in the European Commission’s implementing regulation establishing a list of variations not requiring assessment and the EMA/CMDv Guidance on the details of the classification of variations requiring assessment.

”Regulatory/clinical” means variations categorised as changes to the medicinal product’s safety, efficacy or pharmacovigilance in accordance with the European Commission’s categories of variations. In the case of human medicines, this corresponds to classifications beginning with the letter ”C” in the guidelines from the European Commission1. In the case of veterinary medicines, this corresponds to classifications beginning with the letters ”C” and ”D” and ”E” and ”G” i, respectively, in the European Commission’s implementing regulation establishing a list of variations not requiring assessment and the EMA/CMDv Guidance on the details of the classification of variations requiring assessment.
All variations to veterinary medicines not requiring assessment (VNRA) are charged as “VNRA administrativ” except for classifications beginning with the letters “C” and “D”, which are charged as “VNRA regulatorisk”.

Complex and simple quality variations

Complex quality variations mean applications for type II variations and variations requiring assessment (VRA) that will result in a more complex assessment. The list includes the following variations: 

Human medicinal product

• New manufacturer of active pharmaceutical ingredient or active substance (ASM) applied for with or without ASMF (B.I.a.1.b, B.I.a.1.c, B.I.a.1.e, B.1.a.1.g) or change to raw material manufacturing (B.I.a.2.c, B.I.a.3.c, B.I.a.5)
• Significant change of formulation with/without bioequivalence trials (B.II.a.3.b.2 or B.II.a.3.b.5)
• Significant change of composition of extract/herbal preparation, e.g. in connection with reclassification of extract from standardised or other to quantified extract (B.I.z, B.II.a.z)
• Introduction of real-time release or parametric release (B.II.d.3)
• Introduction of design space (B.I.e.1, B.II.g.1)
• Introduction of post-approval management plan (B.I.e.2, B.II.g.2)
• New finished product manufacturer (B.II.b.1.c), change to finished product manufacturer (B.II.b.3.c) and change in batch size (B.II.b.4.c)
• Significant change in declaration (C.I.4) for herbal medicinal product/traditional herbal medicinal product

If the variation application is not on the above list, the variation is considered to be a simple variation.

Veterinary medicinal product

• New manufacturer of active pharmaceutical ingredient or active substance (ASM) applied for with or without ASMF (F.I.a.1.a, F.I.a.1.b, F.I.a.1.d, F.I.a.1.e) or change to raw material manufacturing (F.I.a.2.b, F.I.a.3.a)
• Significant change of formulation with/without bioequivalence trials (F.II.a.3.b.1, F.II.a.3.b.4)
• Introduction of real-time release or parametric release (F.II.d.3)
• Introduction of design space (F.I.e.1.a, F.I.e.1.b, F.II.g.1.a, F.II.g.1.b)
• Introduction of post-approval management plan (F.I.e.2.a, F.II.g.2.a)
• New finished product manufacturer (F.II.b.1.a), change to finished product manufacturer (F.II.b.3.c) and change in batch size (F.II.b.4.a)

If the variation application is not on the above list, the variation is considered to be a simple variation.

Grouping of veterinary variations requiring assessment (VRA) (Extended mix)

”Extended mix” is a grouped variation application consisting of a mix of safety, efficacy and quality changes requiring assessment. Due to the increased complexity of such a mixed grouping, the review procedure will follow the extended time line and will be subject to a higher fee.

Fee charging/invoicing regarding national procedures and MRP/DCP procedures in general

The Danish Medicines Agency does not require payment at the time the application is submitted but will issue an invoice after the receipt of the application.

The invoice will be issued to the address provided under “Billing address” in the electronic application form. Please tick off ”Proof of payment” at the top and tick off the field ”No”. This will open the field for entering the billing address.

Complete the form with all relevant details including an email address if needed for the handling of the invoice and a “PO number” if relevant. The ”PO number” field can also be used for providing a reference number, an attention person or the like.

If the ”Billing address” field is left empty, the Danish Medicines Agency will send the invoice to the company indicated on the application form as the marketing authorisation holder in Denmark.

Please note that it is not sufficient to provide the billing details in the cover letter only. The application form must be completed with all relevant information.

In the case of veterinary variations not requiring assessment (VNRA), we ask the applicant to fill in the ”Submission comment” field in UPD, detailing which company the Danish Medicines Agency should submit the invoice to, including company name, address, email address and PO number or attention person as needed.

¹ The European Commission’s ”Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures”