Okay, I can help you with that. Here’s a detailed description of Commission Implementing Regulation (EU) 2025\/2091:<\/p>\n
**1. Essence of the Act:**<\/p>\n
This regulation establishes the requirements for Good Manufacturing Practice (GMP) for veterinary medicinal products within the European Union. It aims to ensure the quality, safety, and efficacy of these products by setting standards for their manufacturing, control, and distribution. The regulation addresses specific aspects like sterile products, biological and immunological products, herbal remedies, and products with unique administration methods. It emphasizes a comprehensive pharmaceutical quality system, risk management, and continuous monitoring throughout the product lifecycle.<\/p>\n
**2. Structure and Main Provisions:**<\/p>\n
The regulation is structured into two main parts:<\/p>\n
* **Main Body (Chapters I-XI):** This part outlines the general principles and requirements applicable to all manufacturers of veterinary medicinal products.
\n * **Chapter I (General Provisions):** Defines the scope and subject matter, including specific annexes for certain product types.
\n * **Chapter II (Pharmaceutical Quality System):** Emphasizes the implementation of a comprehensive quality system based on risk management principles.
\n * **Chapter III (Personnel):** Sets requirements for personnel qualifications, training, and hygiene.
\n * **Chapter IV (Premises and Equipment):** Details the standards for manufacturing, storage, and quality control areas, as well as equipment qualification and maintenance.
\n * **Chapter V (Documentation):** Establishes a comprehensive documentation system to ensure traceability and data integrity.
\n * **Chapter VI (Production):** Outlines the requirements for manufacturing operations, handling of materials, and prevention of cross-contamination.
\n * **Chapter VII (Quality Control):** Defines the responsibilities of the quality control department, including sampling, testing, and on-going stability programs.
\n * **Chapter VIII (Certification and Batch Release):** Specifies the role of the qualified person in certifying and releasing batches of veterinary medicinal products.
\n * **Chapter IX (Outsourced Activities):** Sets requirements for outsourcing manufacturing and control activities.
\n * **Chapter X (Quality Defects and Recall of Products):** Establishes systems for handling complaints, investigating quality defects, and managing product recalls.
\n * **Chapter XI (Final Provisions):** States the entry into force and application date of the regulation.
\n* **Annexes (I-IX):** These annexes provide specific requirements and adaptations for particular types of veterinary medicinal products or processes.
\n * **Annex I:** Sterile Products and Aseptic Manufacturing
\n * **Annex II:** Biological and Immunological Products
\n * **Annex III:** Specific Requirements for Certain Veterinary Medicinal Products (herbal, medicated feedingstuffs, ectoparasitic, liquids\/creams\/ointments, medicinal gases, aerosols)
\n * **Annex IV:** Computerised Systems
\n * **Annex V:** Qualification and Validation
\n * **Annex VI:** Template for the Site Master File
\n * **Annex VII:** Use of Ionising Radiation
\n * **Annex VIII:** Model for Batch Release Certificate
\n * **Annex IX:** Real Time Release Testing and Parametric Release<\/p>\n
**Changes Compared to Previous Versions:**<\/p>\n
This regulation repeals Directive 2001\/82\/EC, aligning GMP requirements with Regulation (EU) 2019\/6 on veterinary medicinal products. Key changes include:<\/p>\n
* Emphasis on a comprehensive pharmaceutical quality system and risk management principles.
\n* Specific requirements for the manufacture of sterile, biological, and immunological veterinary medicinal products.
\n* Detailed guidelines for the use of computerised systems and outsourced activities.
\n* Focus on data integrity and traceability throughout the product lifecycle.
\n* Introduction of real-time release testing and parametric release concepts.<\/p>\n
**3. Main Provisions Important for Use:**<\/p>\n
* **Pharmaceutical Quality System (Chapter II):** Manufacturers must implement a comprehensive quality system that covers all aspects of the manufacturing process, from raw materials to finished products. This system should be based on risk management principles and regularly reviewed for effectiveness.
\n* **Prevention of Cross-Contamination (Article 29):** Manufacturers must implement measures to prevent cross-contamination between different products, including the dedication of equipment and facilities, the use of closed systems, and validated cleaning procedures.
\n* **Role of the Qualified Person (Article 38):** The qualified person is responsible for ensuring that each batch of veterinary medicinal product has been manufactured and tested in accordance with the requirements of the marketing authorisation and GMP. They must have access to all relevant documentation and data.
\n* **Outsourced Activities (Chapter IX):** Any outsourcing of manufacturing or control activities must be done under a written contract that clearly defines the responsibilities of each party. The manufacturer remains responsible for the quality of the product.
\n* **Annexes:** The annexes provide specific requirements for certain types of products or processes. Manufacturers must ensure that they comply with the relevant annexes for their products.<\/p>\n
**:** While the act itself does not directly mention Ukraine, it is important to note that this regulation, as part of EU law, may have implications for Ukrainian manufacturers who export veterinary medicinal products to the EU market. Ukrainian manufacturers would need to comply with these GMP standards to ensure their products can be sold in the EU.<\/p>\n