Questions and answers about the naming of medicines

Updated 18 October 2017

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.

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