Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Legal basis
- Re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Costs / Fees
According to Regulation (EU) 2019/6, a marketing authorisation is immediately valid for an unlimited period of time. Monitoring of the marketing authorisation and the safety of a veterinary medicinal product is carried out continuously after authorisation as part of the signal management process. The only exceptions to this rule of unlimited validity are marketing authorisations for limited markets according to Art. 23 of Regulation (EU) 2019/6 and marketing authorisations in exceptional circumstances according to Art. 25. For these types of marketing authorisations, a re-examination of marketing authorisation is foreseen every 5 years for limited markets and every year in exceptional circumstances. The application for re-examination serves the sole purpose of demonstrating that the conditions referred to in Art. 23 (1) are still fulfilled respectively that the exceptional circumstances still apply.
Legal basis
The legal bases for re-examination of marketing authorisations for limited markets and in exceptional circumstances can be found in Art 24 (2) and in Art 27 (2) of Regulation (EU) 2019/6 respectively.
See also BPG
Re-examination of marketing authorisations for limited markets and in exceptional circumstances
The re-examination of marketing authorisations for limited markets as well as the re-examination of marketing authorisations in exceptional circumstances is carried out upon request of the marketing authorisation holder, who has to submit an application at the latest 6 months before the expiry of the validity period of 5 years (limited markets) or at the latest 3 months before the expiry of the validity period of one year (exceptional circumstances). In the course of this re-examination, it is checked whether the conditions according to Art. 23 or 25 and 26 of Regulation (EU) 2019/6 are still fulfilled and whether there is agreement with the updated positive benefit-risk assessment of the marketing authorisation holder.
In case of a positive outcome of the re-examination procedure, the marketing authorisation for limited markets will be extended for another 5 years, the marketing authorisation in exceptional circumstances for another year.
The temporary marketing authorisation can be converted into a marketing authorisation with unlimited validity as soon as the outstanding documents according to Art. 8 of Regulation (EU) 2019/6 are submitted and the respective competent authority decides that a marketing authorisation with unlimited validity can be granted on the basis of the submitted documents on quality, safety or efficacy. In this case the obligation for re-examination process ends.
Costs / Fees
The fee for the re-examination process of a marketing authorisation pursuant to Art. 24 or Art. 27 of Regulation (EU) 2019/6 shall be determined in accordance with the applicable German Cost Regulation, as appropriate.
Find out more
- European marketing authorisation procedures
- National authorisation
- Veterinary medicinal products for food-producing animals
- Assessment of applications for marketing authorisation
- Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Marketability and legal status of supply
- Variation of marketing authorisation, registration, exemption
- SPC harmonisation
- Parallel trade
- Registration
- Co-distribution of veterinary medicinal products
- Examination of registration documents