Regulatory Affairs Veterinary Medicines
The EU registration process or Marketing Authorisation process ensures that only those products meeting defined standards laid down in EU Law and Regulatory Guidelines will be authorised.
Decisions regarding a Marketing Authorisation are based on Safety, Quality and Efficacy.
Service in Regulatory Affairs Veterinary Medicines
Marketing authorisation applications
Strategic regulatory support throughout the entire development, set up clinical trial reports, scientific advice procedures, submissions in order to obtain and maintain marketing authorizations, not limited to the European Union only. EU applications are conform the current EU requirements (Regulation 2019/06).
Outside EU procedures can be requested for.
Application of the following procedures within the EU are possible;
-National Procedure´s (NP)
-Mutual recognition Procedure´s (MRP)
-Decentralised Procedure´s (DCP)
-Limited Market Authorisation Procedure (LMA), EMA
-Centralised Procedures (CP)
Incl. e-Submission and set up of a dossier in TIGes Vet (electronic dossier application), working with Syncplicity, IRIS, CESP and Eudralink.
Guidance and implementations of SPC, label and leaflet´s incl. contact with marketing authorisation authorities.
Dossier Studies related (pharmaceutical (Research and Development), animal incl. Bioequivalent studies, Residue Studies or Ecotox, will be outsourced, after set up within
Vet Online Consultancy and in agreement with the MAH.
Marketing authorisation dossier and maintenance
Registration activities including preparing parts of the Dossier eg. Expert Reports, overviews and quality overall summaries, Variations, Renewals, post- marketing activities like writing Periodic Safety Update Report´s (PSUR´s) for UK-GB, electronic Adverse Event (AE) reporting and Signalling.
'Marketing contact between Pharmaceutical Companies and (future) Marketing Authorisation Holders'
Being the local representative of the Marketing Authorisation Holder within the EU.
'Being the Company’s virtual private Regulatory Affairs and Pharmacovigilance department within the EU'
Parallel Import procedures EU
Informed Consent Applications
Authorisation VMP outside EU on request