On January 28, 2022, the new Veterinary Drugs Act (TAMG) came into force and thus veterinary drugs were exempted from the regulatory area of the Drugs Act (AMG). The EU regulation (EU) 2019/6 has also been in force since this day. It replaces the previous Veterinary Drugs Directive (2001/82/EG). The TAMG serves to implement and specify the new regulation in Germany.
In particular, the new Veterinary Drugs Ordinance creates the legal framework for the approval of veterinary drugs, but also for the acquisition of a manufacturing or wholesale license.
The previously existing regulatory gap with regard to GDP-compliant distribution of veterinary medicinal products and the active ingredients used in them was already closed last year by means of implementing regulations (EU) 2021/1248 and 2021/1280 ( on measures for good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/ 6 or on measures to ensure good distribution practice for active substances used as starting materials for veterinary medicinal products ). The specifications known from the area of medicinal products for human use are mainly found here. An implementation regulation for the GMP area is also planned. At the current time, the EMA calls for the rules known from the Human GMP to be applied (see below under “questions and answers”).
A significant change for testing laboratories resulting from the new legal basis is that a manufacturing license is now also required for participation in the quality control of veterinary medicinal products on a contract basis. An exception to this obligation for external testing laboratories according to § 14 paragraph 4 AMG (which previously existed and continues to exist for the quality control of human medicinal products) is no longer provided for the veterinary medicinal product sector.
As mentioned above, the EMA (European Medicines Agency) is currently also dealing with the topic of veterinary medicinal products and has commented on some GMP-related issues in its “ Questions and Answers ” section ( https://www.ema.europa.eu/ en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers#requirements-for-active-substances-used-as-starting- materials-in-veterinary-medicinal-products-(new-feb-2022)-section ).
The GMP / GDP Guidance website has been expanded to include the topic: "are used". Seven questions were asked that may arise from changes in the new legal situation in the circles concerned, and explained by the EMA. The questions range from clarifying whether the starting materials and active ingredients in veterinary medicinal products have to be of (human) GMP quality (yes, they have to!) to innovations caused by Regulation (EU) 2019/6 to the subject of inspections . Here it is explained whether voluntary inspections triggered by the applicant are possible, how the situation is with inspections that are initiated by the monitoring authorities, and the question of the acceptance of inspections by third countries is also answered.
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