Subject matter and scope
Article 1
1. This Regulation lays down the requirements for good manufacturing practice for veterinary medicinal products. 2. The manufacture of sterile veterinary medicinal products and aseptic manufacturing shall comply with the additional requirements set out in Annex I. 3. The manufacture of biological and immunological veterinary medicinal products shall comply with the additional requirements set out in Annex II. However, this Regulation shall not apply to inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link. 4. Additional requirements and specific adaptations to the requirements laid down in this Regulation are set out in Annex III for the following veterinary medicinal products: (a) herbal veterinary medicinal products; (b) veterinary medicinal products intended for incorporation into medicated feeding stuffs; (c) ectoparasitic veterinary medicinal products for external application; (d) liquids creams and ointments; (e) medicinal gases; (f) pressurised metered dose aerosol products for inhalation. 5. Whilst meeting the requirements laid down in this Regulation demonstrates compliance with good manufacturing practice for veterinary medicinal products, alternative approaches to the requirements provided for in this Regulation may be implemented where it is duly justified that the alternative approach is capable of meeting the same objectives and that the quality, safety and efficacy of the veterinary medicinal product concerned and compliance with the terms of the marketing authorisation is ensured.