--- title: Are your products correctly classified under Article 34, Reg. (EU) 2019/6? description: The Committee for Veterinary Medicinal Products has released a new guideline on the prescription status of veterinary medicinal products. image: https://blog.pqegroup.com/hubfs/Vet%20Questions_1.jpg --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![](https://blog.pqegroup.com/hubfs/blank-user.png) Leonardo Giraudo Pharmacovigilance Compliance expert @PQE Group # **Are your products correctly classified under Article 34, Reg. (EU) 2019/6?** [Regulatory Affairs](https://blog.pqegroup.com/tag/regulatory-affairs) ## Prescription status of Veterinary Medicinal Products  Article 34 of Regulation (EU) 2019/6 has defined the rules applicable for the classification of the prescription of Veterinary Medicinal Products. On 27 January 2023, the Committee for Veterinary Medicinal Products (CVMP) published its guideline on the application of Article 34 of Regulation (EU) 2019/6. Medicines that are on the market and do not require a prescription must be variated for the prescription status through a Variation Requiring Assessment G.I.6 Change in the legal status of a medicinal product for centrally authorized products.        ## 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.   \*\*\* 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    [#2 »](https://blog.pqegroup.com/ra-phv/is-your-pharmacovigilance-systems-master-file-already-approved-and-in-place) ![Vet Questions_1](https://blog.pqegroup.com/hubfs/Vet%20Questions_1.jpg) ## Want to know more? Visit our [Veterinary](https://www2.pqegroup.com/veterinary/) dedicated page **Bring your product into the next generation.** Risking inspection failures is a cost no company can afford: get in touch with us and learn more together with our experts. [Connect with us](https://www2.pqegroup.com/contact-us/) #### More on this topic [Regulatory Affairs ![eCTD as your strategic asset: Rethinking eCTD in Modern Regulatory Affairs](https://blog.pqegroup.com/hubfs/eCTD%20Regulatory%20Affairs_Blog.webp)](https://blog.pqegroup.com/regulatory-affairs/ectd-as-your-strategic-asset-rethinking-ectd-in-modern-regulatory-affairs) 06 Jul 2026 ## [eCTD as your strategic asset: Rethinking eCTD in Modern Regulatory Affairs Transform eCTD from a compliance requirement into a strategic asset. 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