Veterinary products
Veterinary medicinal products (VMPs), known also as veterinary drugs, medicinal products for veterinary use or animal health products are substance or combination of substances that fulfils at least one of the following conditions:
- it is presented as having properties for treating or preventing disease in animals;
- its purpose is to be used in, or administered to, animals to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action;
- its purpose is to be used in animals with a view to making a medical diagnosis;
- its purpose is to be used for euthanasia of animals;
As pharmaceutical products intended for animal use, these products have to be developed according to appropriate guidelines and regulations as well as authorized (obtain Marketing Authorization) before being placed on the EU market(s) in selected countries in the EU. The requirements and procedures for granting Marketing Authorization for veterinary medicinal products are laid down in Regulation (EU) 2019/6 which replaced Directive 2001/82/EC. This regulation focuses on:
- harmonizes the internal market for veterinary medicinal products
- reduces the administrative burden
- enhances the internal market
- stimulates innovation
- provides for incentives to increase the availability of veterinary medicinal products
- strengthens the EU’s action to fight antimicrobial resistance
The veterinary products also require post-marketing activities typical for pharmaceutical products, e.g. regarding pharmacovigilance. If you are planning the development and registration of veterinary medicinal product, or need post-marketing support, contact SciencePharma.
Research and development
We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
Preclinical and clinical development
SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies.
Audits
Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.
Regulatory Affairs
We offer multidisciplinary services in the field of Regulatory Affairs including support for pre-registration, registration and post-registration.
Pharmacovigilance
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders have a legal obligation to set up and maintain a Pharmacovigilance system.