Draft EU GMP Regulations for Veterinary API and Products

Date

March 4, 2025

Category

EU Regulations

Description

On 22 January 2024 the European Commission released two draft implementing Regulations:

• GMP for APIs used in Veterinary Medicinal Products
• GMP for Veterinary Medicinal Products

Both are Regulations that implement requirements in Regulation (EU) 2019/6 and comments were due by 19 February 2025.

GMP for APIs used in veterinary medicinal products

This draft seeks to provide a legal framework for the adoption of VICH guideline GL60, which is an adaptation of the human medicines API GMP guideline ICH Q7. This draft is some 47 pages long and appears to contain the full text of the draft GL60 guideline. This is in contrast to the human medicines Regulation 1252/2014 that provides the legal framework for ICH Q7, which is just 7 pages, with the full text of Q7 being published as Part 2 of the EU GMP Guide.

The text of this draft can be found at https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14388-Veterinary-medicines-rules-on-good-manufacturing-practices-for-active-substances-used-as-starting-materials_en

GMP for veterinary medicinal products

This draft is 40 pages long and has 9 draft annexes. As with the draft API GMP Regulation, it appears to contain the full text of GMP expectations for veterinary products, which appears to be a prelude to changing the scope of EudraLex volume 4 to be just for human medicines.

The draft regulation contains the following Chapters:

1. General Provisions
2. Pharmaceutical Quality Systems
3. Personnel
4. Premises and Equipment
5. Documentation
6. Production
7. Quality Control
8. Certification and Batch Release
9. Outsourced Activities
10. Quality Defects and Recall of Products
11. Final Provisions

The Regulation will apply 8 months after it enters into force.

There are then nine Annexes to the draft Regulation, which largely reproduce the requirements given in the current corresponding Annexes in EudraLex Volume 4:

1. Sterile products and aseptic manufacturing
2. Biological and immunological products
3. Specific requirements for certain veterinary medicinal products.
   1. Herbal Veterinary Products
   2. Veterinary medicinal products intended for incorporation into medicated feedingstuffs.
   3. Ectoparasitic veterinary medicinal products.
   4. Liquids, creams and ointments.
   5. Medicinal gases.
   6. Pressurised metered dose aerosol preparations for inhalation.
4. Computerised systems.
5. Qualification and Validation.
6. Template for the site master file.
7. Use of ionising radiation in the manufacture of veterinary medicinal products.
8. Models for confirmation of partial manufacturing and batch release certificate.
9. Real time release testing and parametric release

The text of the draft regulation and the 9 annexes can be found at https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13994-Veterinary-medicines-rules-on-good-manufacturing-practices_en