When a marketing authorisation for a medicinal product is applied for the MEB assesses the benefits/risk balance for one or more uses. An SmPC and a package leaflet are compiled as part of the application. This product information may contain one or more patented indications.

Due to patent rights the marketing authorisation holder of the generic product may request that the patented indication is not included in the marketing authorisation, nor referred to in the SmPC and package leaflet.

Product information

Removal of patented indication

The marketing authorisation holder can decide to amend the SmPC and package leaflet as described below. The removal of information relating to a patented indication and the inclusion of the standard sentence in the package leaflet falls under the responsibility of the marketing authorisation holder. If the applicant or marketing authorisation holder wishes to remove a patented indication from the product information, an indication is given below per situation as to how this should be done.

Product applied for via national procedure

If the company does not apply for the patented indication during the application for a national marketing authorisation, the MEB will grant the marketing authorisation without the patented indication.

Product authorised via national procedure

If the marketing authorisation holder wants to remove an indication for a nationally authorised product (for which a marketing authorisation has already been granted) due to a patent issue, a variation will always be required for the removal of this indication. This concerns a type IB variation with classification C.I.6.b. After approval of the variation, the indication will no longer be part of the marketing authorisation and it will no longer be referred to in the SmPC and package leaflet.

The submission of the variation contains (in addition to the usual obligatory information about a variation):

  • the text of the SmPC and package leaflet
  • a declaration that the product information fulfils the guidelines below.

Requirements for removing information

When removing information about the patented indication of a generic medicinal product from the SmPC and package leaflet, this must not concern the safety information about the active substance. The MEB has drawn up the following requirements about which information may be removed:

  • Only information about the patented indication in sections 4.1, 4.2 and 5.1 of the SmPC and the corresponding sections of the package leaflet may be removed.
  • In the interest of prescribers and patients, all safety information about the active substance must be retained. This means that the safety information in other sections of the SmPC (4.3 to 4.9) and the corresponding sections of the package leaflet which is related to the patented indication must remain. If the marketing authorisation holder nevertheless wishes to remove or amend information in these sections such as, for example, the removal of text which can be traced to the patented indication, reasons for this must be provided.
  • If a patented indication is not included, the company will include the following standard sentence in the package leaflet:
    ‘<Productnaam> bevat de werkzame stof <stofnaam>, dat ook bij de behandeling van aandoeningen wordt gebruikt die niet in deze bijsluiter staan vermeld. Neem contact op met uw arts of apotheker als u vragen heeft.’

Products applied for via the decentralised or mutual recognition procedure

If the company wishes to remove a patented indication which was included in the approved common EU text after a completed decentralised or mutual recognition procedure, the company must do this during the national implementation phase of this procedure (before the MEB grants the marketing authorisation). The company must submit the Dutch product information during the national implementation phase, without the patented indication, in accordance with the above-mentioned requirements for removing information. The MEB will then grant the marketing authorisation without the patented indication.

In the case of a marketing authorisation subject to further conditions (see MEB 41) the above mentioned policy is not applicable. This is inherent to the fact that a product with a marketing authorisation subject to further conditions is not marketed. The above mentioned policy is applicable as soon as a marketing authorisation subject to further conditions has been transposed into a regular marketing authorisation.

Products authorised via the decentralised or mutual recognition procedure

In the case of products which have already been authorised via the decentralised or mutual recognition procedure, the marketing authorisation holder can remove a patented indication from the Dutch SmPC and package leaflet by submitting a notification with product type 401 to the MEB in the event that this indication is retained in the common EU text. A declaration must also be submitted to the effect that the above-mentioned requirements for removing information have been met. After that the indication will no longer be part of the marketing authorisation and it will no longer be referred to in the SmPC and package leaflet.

Ending of patented indication

If, after the ending (lapsing or becoming invalid) of the patent, the marketing authorisation holder wishes to add the indication to the SmPC and the package leaflet, this must be done in the following manner. Here too a distinction has been made between products authorised via the national procedure and products authorised via the decentralised and mutual recognition procedure.

Product authorised via national procedure

If the marketing authorisation holder wants to add an indication for a nationally authorised product (for which a marketing authorisation has already been granted), a variation will always be required. This concerns a type IB variation with classification C.I.2.a. After approval of the variation the indication will be part of the marketing authorisation and it will be referred to in the SmPC and package leaflet.

Products authorised via the decentralised or mutual recognition procedure

If the marketing authorisation holder for a product authorised via the decentralised or mutual recognition procedure wants to add an indication to the Dutch product information, and this indication is included in the approved common EU text, the marketing authorisation holder must submit the amended Dutch product information to the MEB via a notification with product type 401. This indication will be included in the marketing authorisation and will be referred to in the SmPC and package leaflet.

If this indication has not been stated in the approved common EU text, the company must first submit a type IB variation with classification C.I.2.a via the mutual recognition procedure. After approval of this variation, the indication will be part of the marketing authorisation and it will be referred to in the SmPC and package leaflet.