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:
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:
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.
We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies.
Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.
We offer multidisciplinary services in the field of Regulatory Affairs including support for pre-registration, registration and post-registration.
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.