Periodic safety update reporting (vet.)

The holder of marketing authorisation for a veterinary medicinal product is required to submit periodic safety update reports to the Swedish Medical Products Agency (Läkemedelsverket) regardless of whether the veterinary medicinal product is marketed or not. The periodic safety update report shall contain data related to the current period and the substance in question, as well as a scientific evaluation of the benefit/risk balance of the medicinal product. There is no separate fee for periodic safety update reports.

Centrally authorised veterinary medicinal products

After a veterinary medicinal product has been authorised for marketing the authorisation holder, in accordance with Article 49.3 in Regulation 726/2004*, is required to  submit periodic safety update reports to the European Medicines Agency (EMA) and the Swedish Medical Products Agency. Unless otherwise laid down as conditions for the marketing authorisation, the periodic safety update report shall be submitted immediately on request or in accordance with the following:

  • Every six months after the product has been authorised until the veterinary medicinal product is marketed.
  • If the product is marketed, every six months until the product has been marketed for two years.
  • After the product has been marketed for two years, a periodic safety update report shall be submitted every year over the next two years and every three years thereafter.

Guidelines for the submission of the periodic safety update reports for veterinary medicinal products are available in Volume 9B of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.
Information on the centralised procedure for marketing authorisation is available on the European Medicines Agency (EMA) website.

Nationally authorised veterinary medicinal products

After a veterinary medicinal product has been authorised the marketing authorisation holder, in accordance with § 10 of the Medical Products Agency provision (LVFS 2012:15) on pharmacovigilance for medicinal products for veterinary use, is required to submit periodic safety update reports to the Medical Products Agency. Unless otherwise laid down as conditions for marketing authorisation, periodic safety update reports shall be submitted immediately on request or in accordance with the following:

  • Every six months after the product has been authorised until the veterinary medicinal product is marketed.
  • If the product is marketed, every six months until the product has been marketed for two years.
  • After the product has been marketed for two years, a periodic safety update report shall be submitted every year over the next two years and every three years thereafter.

Guidelines for the submission of periodic safety update reports for veterinary medicinal products are available in Volume 9B of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.

* Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

 
 
 

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