Changes to product information policy

News item | 23-03-2020 | 12:00

The main changes are:

MEB 6: Labelling of pharmaceutical products

• 5.1.3. Packaging for more than one country: the addition that multilingual packaging for countries outside the EEA is only acceptable if the SmPC is the same in all the countries involved and fulfils the requirements of Title V of Directive 2001/83/EC.
   
• Layout: image and text
  • 6.1 Introduction: the addition that images and the layout of the packaging must contribute to the correct use of medicinal products. What is more, the information on the packaging may not be interpreted as a recommendation.
  • 6.3. Assessment criteria: a clarification of the rules relating to the assessment of packaging to make them easier to understand.
  • 6.4.4 Safety features: an addition on the basis of the Falsified Medicines Directive (FMD).

MEB 13: Nomenclature of pharmaceutical products

• 4. Purpose and scope

  • No name confusion: the addition that in relation to generic product names it is possible, in some cases, to deviate from the three letters (characters) difference rule. This is clarified in more detail in section 5.3.

  • Not for promotional purposes: the addition that the names of medicinal products may not directly or indirectly refer to (a recommendation by) scientists or healthcare professionals.

• 5.3 Name of the marketing authorisation holder
  • In the case of a generic product name in which the INN name is followed by the name of the marketing authorisation holder, the names of the marketing authorisation holders no longer have to differ from each other by at least three letters (characters).
     
• 10.1 Combination packages and combination products
  • Combination packaging: in the case of this type of packaging the strengths of the active substances must be separated from each other in the product name by the word 'and' or a plus sign (+).
  • Combination product: the different strengths of the various active substances which are present in a single combination product must be separated from each other by a slash sign (/).

Public consultation

With regard to amending these policy documents the MEB has taken account of questions, comments and experiences from the practice of doctors/pharmacists and the Authorisation Contact Committee (CCR). A public consultation then took place on the proposed amendments in the latter half of 2019. The MEB has weighed up and assessed the responses received. Where possible, they were taken into account.

The new policy comes into effect immediately.