Role of the marketing authorisation holder regarding good manufacturing practice
Article 3
1. The marketing authorisation holder shall ensure that the specifications and instructions submitted to the manufacturer are in accordance with the terms of the marketing authorisation. Changes to the specifications or instructions required to comply with a variation to the terms of the marketing authorisation shall be notified immediately to the manufacturer. 2. The marketing authorisation holder shall communicate swiftly to the manufacturer any information that is relevant to the manufacturing process, as well as any relevant information that may have an impact on the quality, safety and efficacy of the veterinary medicinal product. In turn, the manufacturer shall inform the marketing authorisation holder of any information that is gathered in the context of the manufacturing activities and that is relevant for the quality, safety or efficacy of the veterinary medicinal product. 3. Where the marketing authorisation holder is a different entity than the manufacturer, he or she shall evaluate the results of the product quality review referred to in Article 6 and assess if any appropriate measure should be implemented. 4. The obligations of the marketing authorisation holder and the manufacturer and vis-à-vis each other shall be defined in writing.