Are your products correctly classified under Article 34, Reg. (EU) 2019/6?

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 

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