Questions and answers about the naming of medicines

Updated 22 February 2022

Introduction

Here you can find the answers to frequently asked questions about the naming of medicinal products – see also Naming of medicines

1. What is a D.Sp.No.?

D.Sp.No. stands for ”Danish speciality number”. We allocate a D.Sp.No. to all new applications for marketing authorisations. The number is stated in the marketing authorisation for the medicinal product, in section 0 of the summary of product characteristics and in any other external correspondence about the medicinal product.

Medicinal products that have the same D.Sp.No. are characterised in that they belong to the same product family and form part of the same global marketing authorisation. This is in accordance with section 26 of the Danish executive order on marketing authorisation etc. from 2005, as amended (Danish executive order no. 1239 of 12 December 2005): 

"Section 26. Once a medicinal product has been granted an initial marketing authorisation, any additional animal species, strengths, pharmaceutical forms, routes of administration and pack sizes as well as all changes and renewals must also be authorised or be covered by the original marketing authorisation. All these marketing authorisations are considered to form part of the same overall marketing authorisation."

2. In which cases can medicinal products ”be grouped” and have the same name?

Two or more medicinal products having their own D.Sp.No. and containing the same active substance can be grouped under one D.Sp.No. if the following three criteria have been satisfied:

Criterion I

At least one of the following conditions must be met:

  • Different strengths of the same pharmaceutical form
  • Different pharmaceutical forms 
  • Other conditions, for example different flavours

Criterion II

In addition, a grouping requires that the marketing authorisation holder of all the relevant medicinal products is the same (including the same address).

Criterion III

If the above conditions are satisfied, two or more medicinal products can be grouped under one D.Sp.No. even if they were authorised at different times and/or under different procedures (national, MRP or DCP) and/or with different reference member states. However, the medicinal products must have the same legal basis (Art. 10(1) and 10(3) for human applications and Art. 13(1) and 13(3) for veterinary applications are considered to be the same legal basis).

Medicinal products grouped under one D.Sp.No. must always have the same name. In case of an invented name, suffixes may be added.

Note that a grouping covers all pharmaceutical forms and strengths etc. of a given medicinal product and that none of these can subsequently be sold separately. Before the grouping, the marketing authorisation holder must confirm in writing that this condition is accepted.

3. In which cases can medicinal products not ”be grouped” under one D.Sp.No., nor have the same name as an authorised medicinal product?

A medicinal product authorised under the national procedure, MRP or DCP cannot be grouped with a medicinal product authorised under the centralised procedure, because the marketing authorisation for the latter is issued by the Commission and not by the Danish Medicines Agency as a national authority.

Medicinal products can only be grouped under one D.Sp.No. as long as the number of active substances is not changed. Thus, it is not possible to group a medicinal product containing one active substance with a medicinal product containing several active substances – not even if the medicinal products contain a common active substance and have the same marketing authorisation holder.

4. How do we name a medicinal product authorised via an extension application?

In case of an Extension (extension of the existing marketing authorisation), the new medicinal product must have the same name as the original medicinal product, perhaps with the addition of suffixes.

5. When will the Danish Medicines Agency comment on medicinal product names?

The Danish Medicines Agency only evaluates proposals for medicinal product names based on an actual application.

We comment on medicinal product names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP), on day 30 for MRP and on day 100 for DCP with Denmark as concerned member state, and on day 70 with Denmark as reference member state.

As regards veterinary medicines, we will comment on the name applied for on day 54 (MRP) and on day 100 (DCP).

Regarding medicinal product names applied for under the national procedure, we comment on the name applied for both on day 0 and when we send our day 110 letter.

However, this procedure is subject to the final approval of a name, because in the period until a marketing authorisation has been granted for a medicinal product, other medicinal product names may have been approved that can be confused with the medicinal product name applied for. Consequently, companies should note that the longer the clock stop period for an application, the greater the probability that the medicinal product name applied for - or a similar name with a risk of confusion - has already been approved for another medicinal product, since it is not possible to reserve a name during the procedure.

In addition, other circumstances may also arise, such as changed naming practice, with the result that the name cannot be approved.

6. Are there any special requirements for the naming of prolonged-released oxycodone?

The name of prolonged-release products containing oxycodone must include the Invented name and the suffix ”Depot” (prolonged release). In addition, the pharmaceutical form must be clearly highlighted on the outer packaging.

These special requirements follow from an increase in reports of adverse events (potential mix-ups of prolonged-release tablets and immediate-release medicines). 

7. How do we request an assessment and authorisation of a change in the name of a veterinary medicine prior to the submission of a variation?

Name changes for veterinary medicines are classified as an administrative variation requiring no assessment (A.2). According to the European Commission’s implementing regulation (EU) 2021/17, the new name must be approved by either the European Medicines Agency or the Danish Medicines Agency as applicable.

For the assessment and authorisation of names for medicines authorised under the NP, MRP, DCP or SRP (subsequently MRP) procedure, the marketing authorisation holder must complete a request form (Word). This form is to be sent to the Danish Medicines Agency with the text “Name proposal for a veterinary medicinal product in DK” in the subject field.

The Danish Medicines Agency will return the completed form with its decision after which the name is reserved for a period of 30 days. If a variation is not submitted within 30 days thereafter, the reservation is cancelled automatically, cf. CMDv Best Practice Guide for “Variations not requiring assessment”. This means that a new request must be submitted. 

The Danish Medicines Agency's assigns a case identification number (caseID) to its decision. We encourage applicants to provide this number in the “submission comment field” in UPD when submitting the variation.