Generic Name(s)

Labelling must contain all elements required by Article 54 of Council Directive 2001/83/EEC.

By 30 October 2010, where there are up to three active ingredients in a medicine, all of these will have to appear immediately after the brand name.

This Code of Practice should be read alongside the legislative requirements as set out in Council Directive 2001/83/EC, Article 54. It is a legal requirement for companies to submit full colour actual size mock-ups of packaging to the MHRA as part of an application for a Marketing Authorisation, a variation to an existing Marketing Authorisation which affects the information on the label or an application or notification submitted under Article 61(3) of Council Directive 2001/83/EC to propose changes to the label not impacting on the SmPC.

Ordinary people using OTC medicines do not always give attention to the active ingredients or realise that products utilising the same umbrella brand name may have different active ingredients. The law requires that the pack must include the product name followed by its strength and pharmaceutical form and the generic name(s) of the active ingredients where the product contains up to three active substances. The MHRA require that the generic name(s) appear on the front of the pack immediately after the product name. Any non-statutory information included must be subordinate in placement and prominence to the statutory information.

By 30 October 2010, where there are up to three active ingredients in a medicine, all of these will have to appear immediately after the brand name.

The font size and colour chosen should ensure that the generic name(s) can be seen clearly. Prominence is achieved by means other than just size. Other factors are:

  • Colours used
  • Contrast
  • Other graphics on the pack which may lead the eye away from the statutory information
  • Product name(s) on different faces.

The product name(s) should appear on at least three non-opposing faces of the carton to aid identification whichever way it is stored on a shelf. It is not necessary to repeat the names of the active ingredients on the pack sides or flaps, but where the names of the active ingredients are included, the font sizes should be in the same relative proportion to the product name as they are on the front of the pack.

DOs

The active ingredient(s) must appear immediately after the product name.

DONTs
The product name and generic names(s) should not be broken up by additional information, logos or background text or graphics.

 

SmPCs - Section 2

Sections of the SPC relevant to this section of the Code of Practice are:

Qualitative and quantitative composition (states the active ingredients).