Veterinary medicines are regulated in Europe by Directive 2004/28/EC amending Directive 2001/82/EC. Since January 1st, 2010, the European agencies for medicinal products have progressively started accepting dossiers in electronic format and currently, most European countries accept such electronic submissions. The (electronic) dossier requirements are described in the amended Annex I of this Directive, Directive 2009/9/EC. A guideline for eSubmission has been published by the TIGes-Vet subgroup. ARCHE Consulting can help with the preparation of such submissions. If required, ARCHE Consulting can also follow-up dossiers submitted to national agencies or to the European Medicines Agency until approval.
ARCHE Consulting services for veterinary medicines are:
- Preparation of new dossiers and re-formatting of existing dossiers for Veterinary eSubmission: using correct root folder structures, renaming of files, inserting bookmarks and hyperlinks into documents, generating general tables of contents (GTOC) and tables of contents (TOC), running of VNeeS checker, electronic submission via the Common European Submission Platform (CESP).
- Data gap analysis including study planning, monitoring, data waivers.
- Detailed and critical summaries on the results of:
- pharmaceutical tests (physico-chemical, biological or microbiological)
- safety and residues tests (including risks assessments for users, animals, consumers and the environment)
- clinical trials
- Preparation of Clinical Trial Applications (CTA) for veterinary medicines.
- Risk/benefit analysis.
- Revision and updating of dossiers.
- Preparation of variation and renewal dossiers.
- Preparation and review of labels and Summary of Product Characteristics (SPC).