Veterinary Medicinal Products Registration
Similarly to medicinal products for human use, also for new veterinary medicinal products there is a requirement to carry out a scientific assessment of its registration dossier before they can be placed on the EU market. This assessment is performed by the relevant authorities which, depending on the registration procedure, may be national registration agencies or EMA. Their aim is to ensure a high level of safety, quality and efficacy of medicinal products for use in animals. Only after this assessment and obtaining a marketing authorization it is possible to place a product on the market. This process is known as veterinary medicinal product registration.
What is the veterinary medicinal product registration?
Similarly to medicinal products for humans, the registration of the veterinary medicinal product is a process of exhaustive evaluation covering all the aspects of a new product. Such evaluation is based on the test results and data provided by the applicant. On the basis of this verification a decision to issue a marketing authorisation is taken.
Registration issues for veterinary medicinal products are regulated in the European Union by the Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (hereinafter: EU Regulation 2019/6), which came into force on January 28th 2022. Its aim is to harmonize laws and practices in the EU Member States, as well as improve the safety and availability of veterinary medicinal products and reduce administrative burdens both for applicants and competent authorities.
Registration procedures for a veterinary medicinal product
Veterinary medicinal products may obtain a marketing authorisation in the EU using one of the 4 registration procedures available, which are:
- National procedure (NP) - to obtain a single license in only one Member State;
- Decentralized procedure (DCP) - to obtain a license in several Member States for a new product that so far has not had a marketing authorization in any of the Member States.
- Mutual recognition procedure (MRP) - to obtain a license in several Member States. The MRP is used when the product does have a marketing authorization already granted in one or more Member States, but the Marketing Authorization Holder (MAH) wishes to extend the authorization into further Member States.
- Centralized procedure (CP) - to obtain a single pan-European license.
When choosing the registration route, it is important to remember that for the products listed in Art. 42 of EU Regulation 2019/6, the law requires their registration in the central procedure. This group of products includes:
- veterinary medicinal products developed by means of one of the following biotechnological processes:
- recombinant DNA technology;
- controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells;
- hybridoma and monoclonal antibody methods;
- veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;
- veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;
- biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;
- novel therapy veterinary medicinal products.
Registration dossier for a veterinary medicinal product
Pursuant to Art. 8 of the EU Regulation 2019/6, the basic documents that the applicant must submit to the Agency in order to start the registration procedure include:
- application form containing the information specified in Annex I to the Regulation;
- a summary of the pharmacovigilance system master file;
- technical documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in accordance with the requirements set out in Annex II.
Documentation of the veterinary medicinal product - 4 parts
According to the Annex II of EU Regulation 2019/6 the documentation of a veterinary medicinal product other than an immunological veterinary medicinal product should consist of 4 parts.
Part 1 is a summary of the dossier, including administrative information, product information (Summary of Product Characteristics, Labeling and Package Leaflet), and detailed and critical summaries of the results of pharmaceutical studies, safety and residue studies, pre-clinical and clinical trials, and a test assessing the potential risks posed by the veterinary medicinal product for the environment.
Part 2 is Pharmaceutical information, i.e. physico-chemical, biological or microbiological data that is the quality data of a veterinary medicinal product and includes, inter alia, information on: the qualitative and quantitative composition, stability tests, manufacturing methods and control of starting materials.
Part 3 is, in turn, Safety and residue tests containing, inter alia, pharmacology and toxicology data and environmental risk assessment. In turn, the last 4 part of the documentation is Pre-clinical and clinical trials.
Veterinary medicinal products regsistration with Health-Med
Our Experts have experience in preparing and verifying registration dossiers and in conducting registration procedures for human and veterinary medicinal products. This experience and knowledge is reflected in positive registration results, during which medicinal products under registration are successfully granted marketing authorisation.
Keeping abreast of the latest Competent Authorities requirements is much easier with the support of an experienced and well-informed team.
At Health-Med, we offer comprehensive support at all stages of the registration procedure. We provide assistance in preparing registration dossiers and managing the registration process under National, European and Centralised Procedures registration, depending on the individual needs of the Marketing Authorization Holder.
If you are interested in working with us, please do not hesitate to contact us. Our Experts will answer all your questions and resolve doubts.