Application for expansion of the sales channel

Myyntikanavan laajennushakemus EN

A marketing authorisation applicant or holder may apply for approval for a non-prescription medicinal product to be included in an expanded sales channel, i.e. for sale also at retail stores outside pharmacies. Application for an expanded sales channel is only possible for non-prescription medicinal products whose ATC code is included in the list set out in the Medicines Decree of non-prescription medicines that may also be sold outside pharmacies (list not available in English).

An expanded sales channel may be applied for either in connection with a marketing authorisation application or, for an already authorised product, by means of a variation application. Fimea publishes information on non-prescription medicinal products and their packages that are approved for the expanded sales channel.

Content and handling of the application for expansion of the sales channel

The documentation for an application for an expanded sales channel shall include a concise justification to be placed in Module 1.2 of the application, demonstrating compliance with points 2 and 3 of section 23 e(2) of the Medicines Act (Act not available in English) in the use of the product. This means that the medicinal product intended for sale in an expanded sales channel must be associated with low risks and that treatment with the product can be carried out safely without pharmaceutical advice. At a minimum, the justification document in Module 1.2 must contain a declaration confirming compliance with the above-mentioned provisions of the Medicines Act. The applicant or marketing authorisation holder may provide more extensive justification if deemed necessary. Fimea will request additional information where needed. For ATC class A06AD65 (macrogol, combinations), the statements included in the report of the Parliamentary Social Affairs and Health Committee under “Rajatun itsehoitolääkevalikoiman myyntikanavan laajennus” (report not available in English) should be duly taken into account.

Labelling

As pharmaceutical advice is not available at retail stores outside pharmacies, particular attention should be paid to ensuring that the outer package labelling already approved for the product or proposed in the application complies with currently valid regulations and guidelines, especially with regard to therapeutic indications, target population and instructions for use.
Further information on general requirements for labelling of medicinal products:

The same labelling requirements apply to all non-prescription medicinal products regardless of the place of sale. Packages approved for the expanded sales channel will also remain available for sale in pharmacies.

Pack sizes

As a default, an application for expansion of the sales channel is processed as covering all non-prescription packs included in the marketing authorisation. If the applicant or marketing authorisation holder wishes to restrict the packs to be included in the expanded sales channel so that some non-prescription packs would remain available only in pharmacies, the packs concerned should be specified in the Module 1.2 justification document.

Further information: application for expansion of the sales channel with a variation application

The application must be submitted as a clinical Type II variation (C.z). The application scope field must indicate that the application concerns expansion of the sales channel.
If it is intended to apply simultaneously for both switch to non-prescription status and expansion of the sales channel for a product authorised as a prescription-only medicine, two Type II C.z variations must be submitted as a grouped variation application.

Further information: application for expansion of the sales channel in a marketing authorisation application

In the electronic Application Form, “Supply through non-pharmacy outlets and pharmacies (if applicable)” should be selected in section 2.3.3.
The Module 1.2 justification document should be included already at submission. Fimea will assess the application for expansion of the sales channel as part of the marketing authorisation assessment and decide on it in connection with the marketing authorisation decision.

 

More information about Retail sales of non-prescription medicines.