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 conform Volume 6 Notice to Applicants 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 (2019/06). Outside EU procedures can however 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)
-Minor Use Minor Species (MUMS) Procedure, EMA
-Centralised Procedures (CP)
Incl. e-Submission and set up of a dossier in TIGes Vet (electronic dossier application), working with CESP and Eudralink. Guidance and implementations of SPC, label and leaflet´s incl. contact with marketing authorisation authorities is possible.
Dossier Studies related (pharmaceutical (Research and Development), animal incl. BA/BE studies, Residue Studies or Ecotox) will be outsourced after set up within Vet Online Consultancy and in agreement with the MAH the right party will be sought.
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) and electronic Adverse Event (AE) reporting.
'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
Export and authorisation VMP outside EU on request