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Entry in force of the new amendments to the EU pharmacovigilance rules

Alexander Roussanov

07 November 2013
Obligations related to pharmacovigilance in the EU are governed by the Community Code on medicinal products.  Amendments to the pharmacovigilance rules were adopted in October 2012.  These amendments entered into force on 28 October 2013.

New notification requirements

From 28 October 2013, marketing authorisation holders for medicinal products authorised through the decentralised procedure by the competent authorities of the EU Member States are required to inform these authorities of the specific reasons for the company's decision to take any of the following actions.  For medicinal products centrally authorised by the European Commission, equivalent notification should be made to the European Medicines Agency ("EMA"):

  • temporary or permanent suspension of the marketing of the product in an EU Member State for any reason;
  • temporary or permanent suspension of the marketing of the product in a third country for safety reasons or due to lack of efficacy;
  • withdrawal of the product from a market in an EU Member State for any reason;
  • withdrawal of the product from a market in a third country for safety reasons or due to lack of efficacy;
  • request by the marketing authorisation holder for the withdrawal of the marketing authorisation for the product in an EU Member State for any reason;
  • request by the marketing authorisation holder for the withdrawal of the marketing authorisation for the product in a third country for safety reasons or due to lack of efficacy;
  • a decision not to seek the renewal of the marketing authorisation for the product in an EU Member State for any reason;
  • a decision not to seek the renewal of the marketing authorisation for the product in a third country for safety reasons or lack of efficacy.

Where a marketing authorisation holder for a medicinal product authorised through the decentralised procedure takes any of the actions listed above on the grounds of safety or lack of efficacy of the medicinal product, the notification should be submitted to both the competent authorities that authorised the medicinal products and to the EMA.

Marketing authorisation holders are required to submit notification of the planned, temporary, or permanent suspension of the marketing of a medicinal product at least two months before the suspension.  The notification of all other actions shall be submitted as soon as possible before the marketing authorisation holder takes the action.

The EMA is required to forward notifications received by the Agency to all EU Member States without delay.  The EMA is also required to publish on annual basis a list of medicinal products authorised through the centralised and decentralised marketing authorisation procedures:

  • for which marketing authorisations have been refused, revoked or suspended in the EU;
  • the supply of which has been prohibited; and
  • which have been withdrawn from the market in the EU.

The list published by the EMA shall include the reasons for these actions.

Automatic urgent safety procedures

The competent authorities of the EU Member States or the European Commission may initiate an urgent safety procedure in relation to a medicinal product for which safety concerns have been identified.  The procedure may lead to the variation, suspension or withdrawal of the marketing authorisation for the product.

The urgent safety procedure will automatically apply if the competent authority of an EU Member State or the European Commission takes one of the following actions:

  • suspension or withdrawal of the marketing authorisation for a medicinal product;
  • prohibition of the supply of a medicinal product;
  • refusal to renew the marketing authorisation for a medicinal product.

The urgent safety procedure will also automatically apply if the marketing authorisation holder informs the EMA or the competent authorities of the EU Member States of:

  • the planned suspension of the marketing of a medicinal product for safety reasons;
  • its intention to request the withdrawal of the marketing authorisation for a medicinal product for safety reasons.

Medicinal products subject to additional monitoring

The new amendments to the pharmacovigilance rules have extended the list of medicinal products that are subject to additional monitoring.  This list now includes:

  • medicinal products that contain a new active substance that was not contained in any medicinal product authorised in the EU prior to 1 January 2011;
  • biological medicinal products that have been authorised in the EU after 1 January 2011;
  • medicinal products that are subject to conditional marketing authorisations or marketing authorisations granted in exceptional circumstances;
  • medicinal products that are subject to marketing authorisation requiring the marketing authorisation holder to conduct post-authorisation safety studies.

The Summary of Product Characteristics and the Patient Information Leaflet for medicinal products that are subject to additional monitoring must include a statement reflecting the fact that the product is subject to additional monitoring.  The statement must be preceded by a symbol in the form of a black inverted triangle.  EMA is also required to make public the list of medicinal products that are subject to additional monitoring.

Exemptions from the requirement to translate the labelling and packaging of medicinal products

The Community Code on medicinal products requires that the packaging and labelling of medicinal products be translated into the official languages of the EU Member States in which the product is marketed.  The new amendments to the pharmacovigilance rules permit the EU Member States to provide exemptions from this requirement for medicinal products that are not intended to be made available to patients.  The exemptions may be also granted for medical products for which there are severe supply and availability issues.  EU Member States have the discretion to decide on whether and how to put in place such exemptions.

Alexander Roussanov

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