implementation harmonised productinformation (class labelling)

European agreements on modifying product information for innovative and generic products are made regularly. The MEB strives to harmonise product information across all medicinal products (both generic and innovative).

Class labelling is required for various reasons, such as:

• Changes to product information on the MEB’s initiative, for example, based on CMDh and PhVWP recommendations
• Implementation of PSUR worksharing procedures, resulting in a Core Safety Profile (CSP) for an active substance
• Implementation of Paediatric worksharing procedures (Art. 45 or Art. 46)
• CHMP referral procedures

Actions after defining texts

The marketing authorisation holder is responsible for maintaining up-to-date product information. The MEB publishes an overview of agreed wording for product information per active substance. The overview contains links to defined product information. This information is updated on a monthly basis. Newly added actions can be viewed by selecting the date of decision in the overview.

There are two types of class labelling:

1. active class labelling (the marketing authorisation holder is asked in writing to submit a variation)
2. standard class labelling (no explicit request)

In both cases, the relevant marketing authorisation holders must implement the required changes to the product information by submitting a type 1B variation.

Trigger: CMDh and PhVWP

CMDh and PhVWP recommendations are published monthly on the CMDh website (English-language versions of the defined product information) and since September 2009 also by the PhVWP (concise evaluation report), in principle one week after the CMDh or PhVWP meeting. An overview of discussed topics is available on the page: pharmacovigilance > PhVWP.

Trigger: Paediatric Worksharing

Recommendations for SmPC and package leaflets based on Art. 45 and 46 Paediatric Worksharing are also published on the CMDh website. Dutch translations are published in the overview of agreed wording.

Trigger: CHMP referral

The texts defined after a CHMP referral are published on the European Commission's website.

Trigger: CSP

There are currently no European agreements on the publication of Core Safety Profiles (CSP) defined in the PSUR Worksharing project. The MEB will publish the CSPs in the agreed wording until they are published in a ‘central/European location’.