Practice when applying for a change in the legal status of a human medicinal product

If a marketing authorisation holder applies for a change in the legal status of a human medicinal product from RX to OTC and the product meets the criteria for a change, all medicinal products containing the same substance(s) are changed simultaneously to the new legal status, according our practice. The same applies if the Danish Medicines Agency initiates the change in legal status. After having consulted all marketing authorisation holders of medicinal products containing the relevant substance(s), the Danish Medicines Agency sets the date of implementation.

If a centrally authorised medicine has been authorised with a limited indication area and has been given OTC status, the Danish Medicines Agency now makes it possible for the individual marketing authorisation holders to apply for a similar limitation of the indication area for their medicinal products and at the same time apply for OTC status for a medicinal product authorised via the national procedure with a broader indication area, without changing the legal status at the same time for other nationally authorised medicinal products containing the same substance(s) in the same pharmaceutical form and strength.

As regards MRP/DCP authorised medicinal products, the Danish Medicines Agency presupposes that the change in legal status in Denmark does not imply any changes to the Danish product information compared with the harmonised and approved common product information. In case of changes to the product information, they must be applied for by way of an MRP variation before the submission of a national variation application for change of legal status.

It is not a requirement that the centrally authorised medicine was used as reference medicinal product during the original approval procedure.

A medicinal product applied for via the national procedure may be authorised with the same indication area as a centrally authorised product. Note, however, that two different summaries of product characteristics cannot be approved for the same package size within one MT number.

In spite of this new possibility, the Danish Medicines Agency may still decide that a change of legal status should take place simultaneously for all nationally authorised medicinal products containing the same substance(s), if this is considered appropriate.

The Danish Medicines Agency can only determine the legal status for medicinal products authorised under the national procedure. Consequently, substances authorised both via the centralised procedure (CP) and the national procedure or the mutual recognition and decentralised procedures (MRP/DCP) may have a different legal status for the same pharmaceutical form and strength. The reason may be that the medicinal products are authorised on the basis of different dossiers and have been approved for different indication areas.

This does not impact the general possibility to apply for a change of legal status. A change of legal status should be applied for as a national type II variation, no. C.I.4.

Links

The Danish Medicines Agency’s legal authority to determine the legal status is contained in section 61 in the Consolidated Danish Medicines Act no. 99 of 16 January 2018.

The criteria for the prescription-only requirement appear from the Danish executive order no. 857 of 12 June 2020 on prescriptions, as amended (in Danish).

The Danish Medicines Agency uses the European Commission’s guideline A Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use, January 2006 when assessing the prescription-only requirement.