Commission Implementing Regulation (EU) 2021/1248, of 29 July 2021, establishes measures relating to Good Distribution Practices for the Veterinary Medicinal Porducts. Good Distribution Practices apply to holders of authorizations for the wholesale distribution of medicinal products, as well as holders of manufacturing authorizations involved in distribution activities (including warehousing).

This new Regulation is heavily based on the GDP Guidelines for Medicinal Products for Human Use ("Guidelines of 5 November 2013 relating to good distribution practices for the medicinal products for human use - 2013/C 343/01").

The Good Distribution Practices for the Veterinary Medicines are divided into 11 chapters and 40 articles:

I - GENERAL PROVISIONS Subject matter, scope and definitions.

II - QUALITY MANAGEMENT Quality system (development, maintenance, requirements, management, review and monitoring and risk management).

III - PERSONNEL REQUIREMNTS Responsible person and their obligations, other personnel, training, hygiene.

IV - PREMISES AND EQUIPMENT Premises, environmental control, equipment, computer systems, qualification and validation.

V - DOCUMENTATION, PROCEDURES, AND RECORD-KEEPING Requirements, procedures and records.

VI - OPERATIONS Requirements for all operations that interfere with GDP, including customer and supplier qualification, product destruction and export.

VII - COMPLAINTS, RETURNS, SUSPECTED FALSIFIED VETERINARY MEDICINAL PRODUCTS AND RECALLS Activities for the handling of returns, complaints, recalls and suspicions of falsified veterinary medicinal products.

VIII - OUTSOURCED ACTIVITIES Quality agreements between the target entities of the contract.

IX - SELF-INSPECTIONS Program, conduct and recording of self-inspections.

X - TRANSPORT Requirements, containers, packaging and labelling, products requiring special conditions.


Reference: Commission Implementing Regulation (EU) 2021/1248, of 29 July 2021

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