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Conditions that request Veterinary Prescription
A Veterinary Medicinal Product is subject to prescription if it:
- contains narcotic drugs or psychotropic substances,
- is intended for food-producing animals,
- contains antimicrobial substances,
- is intended for treatments of pathological processes which require a precise prior diagnosis,
- is used for the euthanasia of animals,
- contains an active substance that has been authorized for less than five years in the Union,
- is an immunological product,
- contains active substances having a hormonal or thyrostatic action or beta-agonists.
Exemptions for a medicinal without prescription
Exemptions are admitted, with the exception of narcotics, antimicrobials, euthanasia products, thyrostatic and beta-agonists if:
- the pharmaceutical form does not require particular knowledge or skill in using the product;
- the product does not represent a direct or indirect risk even if administered incorrectly;
- the product information does not contain any warnings of potentially serious adverse events that are derived from its correct use;
- neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;
- the product information does not refer to contra-indications related to the use of the product concerned in combination with other veterinary medicinal products commonly used without a prescription;
- there is no risk to public health with regard to residues in food;
- there is no risk to public or animal health with regard to the development of resistance to substances.
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PQE Group can provide support to your business and ensure the full compliance with the new guidelines in veterinary medicinal products. Our services portfolio guarantees a comprehensive solution to cover all of your needs by using our Glocal approach -- we work at a local level while maintaining a global mindset. We offer:
- Webinars and trainings to educate your workforce on the new concepts of the recent release
- Support for integrating new concepts and methodologies in your QMS
- Workshops, Assessments & Gap Analysis oriented to prepare for the update of the CVMP
- Writing of new procedures and/or updating existing ones
- Support for the application of new concepts to real (pilot) projects, systems, equipment and infrastructures
Bibliography
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. (2019). Bruxelles: Official Journal of the European Union.
EMA/CVMP/273040/2022 Committee for Veterinary Medicinal Products (CVMP) Guideline on the application of Article 34 of Regulation (EU) 2019/6 Classification of veterinary medicinal products (prescription status)
EMA/CMDv/7381/2021 - Rev.1 Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
Veterinary product information templates [Version 9, 03/2022] corr. 11/2022
