Sachkundige Person for Veterinary Medicines (Reg. (EU) 2019/6, Art. 97)

Who is the sachkundige Person for veterinary medicinal products under Regulation (EU) 2019/6?

Two different people carry that label. Article 97 names the qualified person responsible for manufacturing and batch release, the sachkundige Person whom every holder of a Herstellungserlaubnis must have permanently at its disposal. She needs a university degree in pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology, plus two years of practical experience in authorised manufacturing. Article 77(8) names a second, the qualified person responsible for pharmacovigilance, who works for the marketing authorisation holder, must reside and operate in the Union, and carries out the tasks in Article 78. Germany layers the Tierarzneimittelgesetz on top. The BVL authorises the products, the Länder license the plants.

The Bundesverband für Tiergesundheit reported on 8 May 2026 that the German veterinary medicines market grew 4.7 per cent in 2025, to 1,098 million euro across 24 member companies. Behind every batch that reaches a vet practice or a pig unit stands one named person who signed the control report.

I have recruited in pharma for 16 years, eight of them at Bayer and five with large CROs, and animal health is the corner where I get the fewest CVs and the most urgent briefs. Companies ring me because a sachkundige Person gave notice and the authorisation now has a 30 day clock on it. Almost everyone who could do the job sits in human pharma and has never opened Regulation (EU) 2019/6. The general route is in my piece on the sachkundige Person under § 14 AMG, the safety side in the one on the Stufenplanbeauftragter and QPPV.

What 28 January 2022 changed

Regulation (EU) 2019/6 of 11 December 2018 applies from 28 January 2022 under Article 160, and Article 149 repeals Directive 2001/82/EC outright.

That is not cosmetic. A Directive had to be transposed, so the German rules for veterinary manufacture used to live inside the Arzneimittelgesetz. A Regulation applies directly. Germany then passed the Tierarzneimittelgesetz vom 27. September 2021 (BGBl. I S. 4530), the Gesetz über den Verkehr mit Tierarzneimitteln und zur Durchführung unionsrechtlicher Vorschriften betreffend Tierarzneimittel, which pulled veterinary medicines out of the AMG. Regulation (EU) 2019/4 on medicated feed started the same day. When a veterinary advert still says "sachkundige Person nach § 14 AMG", the file has not been touched since 2021.

Article 97 is manufacturing, Article 78 is safety

Article 97 is headed "Qualified person responsible for manufacturing and batch release". Paragraph 1 requires the holder of a manufacturing authorisation to have "permanently at its disposal the services of at least one qualified person who fulfils the conditions laid down in this Article". Paragraph 6 is the core act: she ensures each batch is manufactured in compliance with good manufacturing practice and tested in compliance with the terms of the marketing authorisation, and draws up a control report valid throughout the Union.

The pharmacovigilance person sits elsewhere. Article 77(8) makes the marketing authorisation holder designate one or more qualified persons responsible for pharmacovigilance to carry out the eleven tasks in Article 78, from maintaining the pharmacovigilance system master file to communicating third country regulatory measures within 21 days. Article 78(2) makes her the contact point for inspections.

Article 100, sometimes miscited for the manufacturing role, covers wholesale distribution authorisations and requires "at least one person designated as responsible person, meeting the conditions provided for in national law". That is the verantwortliche Person of the wholesaler, and § 19 TAMG carries the German power to regulate her appointment.

What the manufacturing sachkundige Person must prove

Article 97(2) is short and unusually generous. The person "shall hold a university degree in one or more of the following scientific disciplines: pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology." No minimum course length, no prescribed syllabus.

Article 97(3) requires practical experience "over at least two years, in one or more undertakings which are authorised manufacturers, in the activities of quality assurance of medicinal products, of qualitative analysis of medicinal products, of quantitative analysis of active substances and the checking necessary to ensure the quality of veterinary medicinal products." Read "authorised manufacturers" again. Nowhere does the Regulation say those two years must have been served in a veterinary plant. The period drops by one year for a five year course and by eighteen months for a six year course.

Germany supplies the evidence rules. § 17 TAMG, headed Nachweis über die erforderliche Sachkunde der für die Herstellung und die Chargenfreigabe verantwortlichen sachkundigen Person, requires proof of Article 97(2) and (3) through a university certificate and documentation of the activity. § 15 TAMG lists what the application must contain beyond Article 89(2), and the Landesamt für Verbraucherschutz und Ernährung NRW additionally wants a declaration that "die ständige Ausübung der ihr im Rahmen der Herstellungserlaubnis obliegenden Verpflichtungen gesichert ist".

How this differs from § 14 AMG

The human framework is stricter on paper. § 15 Absatz 2 AMG requires the degree course itself to have covered named subjects, among them Analytische Chemie, Pharmazeutische Technologie and Toxikologie. Article 97 names no subjects at all. The Danish Medicines Agency draws the practical conclusion: where a manufacturing authorisation covers both human and veterinary medicinal products, the educational requirements for human products apply. A § 15 AMG qualified person therefore clears Article 97 easily, while the reverse fails on a dual scope site.

Nothing forbids one individual from holding both appointments, and on small dual scope sites that is normal. Article 93(1) obliges the holder to have her services at its disposal, to give her access to documents, premises and testing facilities, and to notify the authority at least 30 days before replacing her. There is no statutory dismissal protection. That notification is a brake on the company, not a shield for the person.

The QPPV vet and the Pharmakovigilanz-Stammdokument

Article 77(8) sets four conditions. The qualified persons responsible for pharmacovigilance "shall reside and operate in the Union and shall be appropriately qualified and be permanently at the disposal of the marketing authorisation holder. Only one such qualified person shall be designated for each pharmacovigilance system master file." Article 77(9) lets the Article 78 tasks be outsourced to a third party where the arrangement is detailed in the contract and in the master file.

Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 fills in the qualification. Its Article 3 requires documented experience in pharmacovigilance, then adds the condition that catches most human pharma applicants. The person "shall have completed veterinary surgeon training in accordance with Article 38 of Directive 2005/36/EC. Where such training has not been completed, marketing authorisation holders shall make arrangements to ensure that the qualified person responsible for pharmacovigilance is assisted by a veterinary surgeon on a continuous basis." The German text calls her the für die Pharmakovigilanz verantwortliche qualifizierte Person.

The Pharmakovigilanz-Stammdokument comes from Article 77(2); no product may have more than one. Article 22 of that Implementing Regulation splits its main part into six sections lettered A to F plus annexes, covering the qualified person and her back-up, the veterinary surgeon arrangement, document management, the quality system and contracted third parties. EMA guideline EMA/595115/2021 extends the EU location rule to Norway, Iceland and Liechtenstein. Article 76(2) sets 30 days from receipt for recording suspected adverse events in the Union pharmacovigilance database of Article 74. Article 73 makes that term far wider than human pharmacovigilance people expect. Lack of efficacy counts, as do environmental incidents, noxious reactions in exposed humans, and residues above maximum limits after the withdrawal period has run.

Databases, antibiotic volumes, and who supervises

Article 55 obliges the Agency to maintain the Union Product Database, live since January 2022 as the single source on authorised veterinary medicines in the EU and EEA. Article 58(12) makes the marketing authorisation holder record the annual volume of sales for each product in it.

Antimicrobials carry a second stack. Article 57 requires Member States to collect data on the volume of sales and on the use of antimicrobial medicinal products in animals, supplemented by Commission Delegated Regulation (EU) 2021/578 and reported to the EMA through its Antimicrobial Sales and Use platform. In Germany the industry duty runs to the Tierarzneimittel-Abgabemengen-Register at the BVL: manufacturers and holders of a Großhandelsvertriebserlaubnis report under § 45 Absatz 6 Nummer 1 und Nummer 2 TAMG, as XML, by 31 March each year. A new § 61a TAMG, announced by the BVL on 19 December 2025, extends usage reporting from 2026 to horses, geese, ducks, sheep, goats, meat rabbits and some fish.

Competence is split. The BVL authorises veterinary medicinal products, while the Paul-Ehrlich-Institut holds the Zuständigkeit für die Zulassung von Sera und Impfstoffen für Tiere. The Länder license and inspect the sites, and § 28 Absatz 1 TAMG puts the Herstellungserlaubnis with "die zuständige Behörde des Landes, in dem die Betriebsstätte liegt oder liegen soll". At EU level the EMA and its CVMP run the centralised route, with BVL experts on that committee.

Where the jobs are and what a CV must carry

The employer set is small and easy to map. Animal health arms of large groups such as Boehringer Ingelheim Vetmedica, MSD Tiergesundheit Intervet Deutschland, Elanco Deutschland, Zoetis Deutschland, Ceva Tiergesundheit, Virbac and Vetoquinol. Mid-sized German specialists including aniMedica, Bela-Pharm, CP-Pharma, Selectavet, Veyx Pharma and Serumwerk Bernburg. Contract manufacturers running veterinary lines beside human ones. Importers, whose Article 97 person also carries Article 97(7), the full qualitative and quantitative analysis in the Union of at least all active substances in every imported batch. Medicated feed producers under Regulation (EU) 2019/4 sit next door. Low hundreds of appointments, turning over slowly because they are personal.

Pay depends on whether the seat is combined with Leiter der Herstellung or Leiter der Qualitätskontrolle, on plant size, on dual scope, and on whether the person also carries the human § 14 AMG appointment. I have no citable band for it, so I will not print one. What a CV must show is narrow and checkable: the degree certificate in one of the six disciplines, and dated employment evidence that the two years ran inside undertakings holding a manufacturing authorisation, phrased in the vocabulary of Article 97(3) instead of internal job titles. For the safety seat, documented pharmacovigilance experience and either the veterinary qualification or an account of the veterinary assistance you worked under. Write the German strings verbatim, sachkundige Person, Herstellungserlaubnis, Chargenfreigabe, Pharmakovigilanz-Stammdokument.

Frequently asked questions

Can a qualified person from human pharma take over a veterinary site?

Yes, and the route is shorter than most assume. Article 97(3) requires the two years "in one or more undertakings which are authorised manufacturers" without restricting that to veterinary manufacturers, and Article 97(2) lists disciplines any § 15 AMG qualified person already holds. Your Land authority assesses the appointment against the dosage forms on that licence.

Does the veterinary QPPV have to be a vet?

Not necessarily. Article 3(2) of Commission Implementing Regulation (EU) 2021/1281 requires veterinary surgeon training under Article 38 of Directive 2005/36/EC, but where that training has not been completed the holder must arrange continuous assistance by a veterinary surgeon, duly documented and described in the master file. A pharmacist with real pharmacovigilance experience can hold the seat if the company builds that arrangement and writes it down.

Is the Stufenplanbeauftragter still relevant for veterinary products?

Not for products inside the scope of Regulation (EU) 2019/6. § 34 TAMG routes veterinary pharmacovigilance to Chapter IV Section 5 of the Regulation, so the Article 77(8) qualified person replaced the old national construction. Companies holding human authorisations still need the § 63a AMG Stufenplanbeauftragter for that portfolio.

Can the role be held externally or part time?

Article 77(9) permits the Article 78 tasks to be outsourced to a third party where the arrangement is detailed in the contract and in the master file. For manufacturing, Article 97(1) requires the qualified person to be "permanently at its disposal", which allows contracted or part-time work but not an absentee name.

Sources

Looking at a veterinary qualified person seat?

Book a free getting-to-know call. I will tell you honestly whether your existing § 14 AMG file already covers Article 97 or what evidence is still missing.

Book a Free Getting to Know Call