Harmonisation of package leaflets and summaries of product characteristics

Updated 11 April 2012

Harmonisation of Danish package leaflets (PLs) and summaries of product characteristics (SPCs) of nationally authorised medicinal products for humans and herbal medicinal products/natural remedies

The national harmonisation project of the SPCs and PLs was completed with the close of 2008. It has been decided that we will maintain the harmonisation project by concentrating on changes to safety-related information, i.e. the updating of:

Section 4.3       Contraindications
Section 4.6       Warnings related to fertility, pregnancy and lactation
Section 4.8       Undesirable effects

In connection with type II variations, the we will request the relevant companies to submit an updated SPC.

The harmonisation project is described below.


Purpose of the harmonisation project

The purpose of the project is to achieve linguistically homogeneous package leaflets that are easy to understand and read for users. Another purpose is to ensure that the package leaflets contain the same factual safety information for all medicinal products containing the same active substance.

Background

There must be a package leaflet in all medicinal product packs, with the exception of products solely intended to be administered by healthcare professionals or veterinarians.

The package leaflets were often not easy to read and absolutely not understandable to the users. Moreover, the factual contents of the package leaflets of medicinal products containing the same active substance were not consistent, e.g. with regard to adverse drug reactions and information about pregnancy and breast-feeding. This makes it difficult to understand for patients who may be given different medicinal products each time due to the substitution rules.

The harmonisation project does not comprise:

  • human medicinal products authorised according to the MRP,
  • veterinary medicinal products,
  • nationally authorised vitamin and mineral products,
  • medicinal products authorised according to the centralised procedure.

For medicinal products/pharmaceutical forms which do not require package leaflets, the harmonisation only comprises the SPC, if the company does not want a package leaflet.

As the package leaflets must be in conformity with the summaries of product characteristics, it is a precondition for the harmonisation of the package leaflets that the summaries of product characteristics are harmonised first. Therefore, the harmonisation project has two steps.

  • Harmonisation of the summaries of product characteristics,
  • Harmonisation of the package leaflets.

Harmonisation of the summaries of product characteristics

Harmonisation of the summaries of product characteristics comprises the following aspects, cf. the summary of product characteristics:

  • 4.3 – 4.9 (safety information).
  • 4.1: Not included in the harmonisation project.
  • 4.2: Actual changes to the dosage are not included in the harmonisation project, but linguistic changes and adjustments may be made.
  • 5.1 – 5.3 Changes and updates are not included in the harmonisation project.

An update of the following is also made:

  • 2. according to the Danish Drug Standards (Danske Lægemiddelstandarder – abbreviated DLS).
  • 3. pharmaceutical form according to the DLS and a visual description of the medicinal product's appearance must be provided.
  • 6.1 – 6.6 according to the DLS and the guidelines.
  • actual changes to 2.3 or 6.1 – 6.6 are not included in the harmonisation project.

Headings should follow the current QRD template, and "standard texts" in the current guidelines must be used.

Harmonisation of package leaflets

The harmonisation of package leaflets focuses on the following:

  • compliance with the guidelines,
  • compliance with standard headings and standard texts,
  • compliance with the summary of product characteristics,
  • the same factual information must be written in the same way,
  • the package leaflet must be comprehensible,
  • the package leaflet should not contain any medical terms that ordinary users do not know,
  • the package leaflet must be easy to read,
  • package leaflet should not use passives,
  • the Danish word "man" (one/you) should not be used,
  • frequency must be stated for all adverse drug reactions.

Headings and sequential order should follow the current QRD template, and "standard texts" etc. in the current guidelines must be used.

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