Directive 2010/84/EU amending Directive 2001/83/EC and Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004 introduced new rules on pharmacovigilance. In addition, an implementing regulation with more precise requirements on content and format of documents and systems that marketing authorisation holders are obliged to fulfil has been adopted. The necessary amendments in Swedish law, including the MPAs provisions, became effective 21 July 2012.

Further information on the new legislation on pharmacovigilance can be found on the MPAs website: Ny-EU-lagstiftning-for-lakemedel (in Swedish).

New and revised provisions (in Swedish)

  • Läkemedelsverkets föreskrifter (LVFS 2012:14) om säkerhetsövervakning av humanläkemedel
  • Föreskrifter om ändring i Läkemedelsverkets föreskrifter (LVFS 2006:11) om godkännande av läkemedel för försäljning m.m.
  • Föreskrifter om ändring i Läkemedelsverkets föreskrifter (LVFS 2006:3) om traditionella växtbaserade läkemedel för humant bruk
  • Föreskrifter om ändring i Läkemedelsverkets föreskrifter (LVFS 2005:11) om märkning och bipacksedlar för läkemedel

Good Pharmacovigilance Practice (GVP)

A new set of guidelines on Good Pharmacovigilance Practice (GVP) is under development which, once adopted, will replace EudraLex Volume 9A. EudraLex Volume 9A remains the references as applicable until the transition period ends or until that specific GVP modules are published as final. The GVP modules are published on the EMAs website

Pharmacovigilance system

The marketing authorisation holder for a medicinal product (herbal medicinal products, certain medicinal products for external use or natural remedies) or the registration holder for a traditional herbal medicinal product must operate a pharmacovigilance system. More details on the format of the system are found in the GVP Module II. The pharmacovigilance system master file (PSMF) will have to be in place either at the time of the date of the following renewal, if applicable, or by 21 July 2015 (for nationally authorised / registered medicinal products), whichever is the earliest. These requirements apply to all authorised / registered medicinal products with or without a detailed description of the pharmacovigilance system (DDPS) in their dossier. It is not required for registered traditional herbal medicinal products to submit a summary of the pharmacovigilance system, but it must be available for inspection. In order to introduce the new pharmacovigilance system, a variation application should be submitted to the MPA.

Risk management system and risk management plan

The requirement to operate a risk management system applies as a general rule for medicinal products where the application is received after 21 July 2012. Risk management system and risk management plan are described in the GVP. The submission of a risk management plan is not required for an application for a traditional herbal medicinal product. In cases where a change in the relationship between the benefits and the risks of a medicinal product approved before the entry into force (21 July 2012) is suspected, the MPA may request that a risk management system is established for the medicinal product.

Periodic safety update reports (PSURs)

For traditional herbal medicinal products and medicinal products authorised through a bibliographic application (Article 10 of Directive 2001/83/EC, medicinal products with well established medicinal use) the requirements to submit PSUR is waived. This derogation to submit PSURs applies unless PSUR submission is requested by the MPA on the basis of concerns relating to pharmacovigilance data or the substance is included in the EURD list (Public list of Union reference dates and frequency of submission of periodic safety update reports) that is published by the European Medicines Agency (EMA). The first EURD list will come into force 6 months after its publication as final (6 months after 1 October 2012) and will be regularly updated. During the transition period the requirements to submit PSURs for traditional herbal medicinal products and medicinal products authorised through a bibliographic application is waived.



Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | | Contact information