Verantwortlicher under the German Narcotics Act: the named role behind a BtM licence

Some named roles in German pharma are famous enough to appear in job titles. This one usually hides in a sentence near the bottom of a job ad, phrased as experience as BtM-Verantwortlicher desirable, and hardly anyone can explain what standing behind it.

Controlled substances run through more of the industry than people assume. Opioid analgesics, ADHD medication, anaesthetics, benzodiazepines, medical cannabis, plus a long list of substances used in research and analytics. Every company that touches them commercially needs a licence, and every licence needs a person. I write this from 16 years recruiting in pharma, where the candidates who could genuinely hold a named statutory function were always the shortest supply.

The licence and the person behind it

The structure is straightforward once you see it. Cultivating, manufacturing, trading, importing, exporting or otherwise handling controlled substances requires a licence under § 3 BtMG, issued by the Bundesopiumstelle at BfArM. The application under § 7 BtMG has to name, among other things, the person who will be responsible.

Then § 5 BtMG turns that into a hard condition. The licence is refused unless it is assured that a person will be appointed at the site who is responsible for compliance with the Act and with the orders and conditions attached to the licence. The applicant can hold that position personally. And it is refused if the designated responsible person does not have the required expertise, or cannot continuously fulfil the obligations that come with the position. That second half is the one companies underestimate. Continuously means the function has to be covered in reality, not on paper, which is why deputies get appointed and why a person who is rarely on site is a problem for the licence file.

What the job looks like from the inside

The daily substance of the role is control. Controlled substances have to be secured against unauthorised access, which turns into vault specifications, access rights, alarm concepts and the discipline to keep them intact when a production line is behind schedule. Every movement has to be recorded, and the records have to reconcile: what came in, what went into production, what was rejected, what was destroyed and in whose presence, what is physically in the safe right now. Reporting duties toward the Bundesopiumstelle run on their own calendar. Import and export need separate authorisations per shipment.

What makes the role different from other quality functions is the tone of the oversight. Discrepancies here are not deviations to be trended. A missing quantity of a controlled substance is a matter for the authority, and possibly for the police, and the named person is the one who has to explain it. Candidates who have run a real reconciliation gap and come out of it with the process intact carry something on their record that cannot be taught in a course.

The expertise the statute wants

§ 6 BtMG sets out the proof of expertise, and the route depends on what the company does with the substances. Where controlled substances or exempt preparations are manufactured as medicinal products, the provision points at the expertise required under § 15(1) AMG, the same test that governs the sachkundige Person. For veterinary medicinal products it refers to the requirements of Regulation (EU) 2019/6. For controlled substances that are not medicinal products, it asks for a completed university degree in biology, chemistry, pharmacy, human or veterinary medicine together with at least a year of practical work in the manufacture or testing of controlled substances. For scientific use, the degree certificate in those fields. And in the remaining cases, commercial training in the chemical or pharmaceutical wholesale trade plus at least a year of practical work in the narcotics trade.

§ 6(2) then allows BfArM to depart from those requirements in individual cases, as long as the necessary safety and control of the trade in controlled substances stay assured. Read the whole provision before you assume you are out, and read it against your company's actual activity rather than its industry label. Which route applies is a question for the authority and, in a borderline case, for a lawyer.

Who appoints one

Manufacturers of finished products and active ingredients in the controlled range. Wholesalers and pharmaceutical trading companies carrying opioids or benzodiazepines. Importers and exporters. Contract manufacturers and packagers. Clinical trial supply units shipping controlled comparators. Analytical and reference-standard laboratories. Universities and research institutes. And the medical cannabis sector, which since legalisation has built a supply chain of cultivators, importers and distributors that all sit inside this regime and have been hiring into it.

In smaller companies the function lands on someone who already holds another named seat, often the sachkundige Person, the head of manufacturing or quality control, or the responsible person for wholesale distribution under § 52a AMG. Combined mandates are normal, and they are paid accordingly. In larger sites the role sits inside quality or production with a named deputy and a very specific set of standard operating procedures.

The routes in

Most people arrive sideways rather than by aiming. A QC or QA scientist takes over the controlled substances documentation. A warehouse or logistics lead at a wholesaler picks up the vault and the reconciliation. A pharmacist in industry inherits it with a quality portfolio. The deputy appointment is again the classic springboard, because the licence needs continuous coverage and the authority has already seen the deputy's file.

What almost never works is arriving with a strong CV and no controlled substances exposure at all, because the expertise routes ask for practical work with the substances. If you want this on your record, the move to make is internal and unglamorous: volunteer for the reconciliation, the destruction protocols, the annual reporting, the authority inspection. Two years of that is worth more in this niche than any external course.

What a CV has to evidence for this role

Be specific about substances and scope. Which schedules under the Act you have handled, whether you worked with narcotic active ingredients or only finished products, storage volumes, whether import and export authorisations ran through you. Name the systems you kept the records in. Put down every inspection by the Bundesopiumstelle or the state authority with the year and your part in it. If you hold or held the appointment, or the deputy appointment, write it explicitly with dates, and say whether it was combined with another named function. Recruiters and applicant tracking systems search for the German strings, so BtM-Verantwortlicher and Betäubungsmittel belong in the document literally; how that filtering works is in my guide on the ATS in pharma.

A note on salary

I will not quote a band. Pay here follows the surrounding role rather than the appointment, and the appointment is almost always combined with something else, so the variables that matter are which other named functions you hold, the size and risk of the site, and whether the employer is a wholesaler, a manufacturer or a cannabis importer with a young organisation. A single figure would mislead you. The reliable part: the niche is narrow enough that a credible candidate has real leverage, and companies with a licence at risk move quickly.

Frequently asked questions

Do you have to be a pharmacist to be the BtM-Verantwortlicher?

No. § 6 BtMG sets out several routes to the required expertise, and which applies depends on what the company does with the substances. Pharmacy is one of the listed degrees for some routes, biology, chemistry, human and veterinary medicine appear alongside it, and for parts of the trade a commercial training in chemical or pharmaceutical wholesale plus a year of practical work in the narcotics trade is what the provision names. BfArM may also depart from the requirements in individual cases under § 6(2).

Which authority issues the licence?

The Bundesopiumstelle at the Federal Institute for Drugs and Medical Devices, BfArM, issues the licence under § 3 BtMG and is the authority the responsible person deals with for reporting, import and export authorisations and inspections.

Can the role be combined with other named functions?

Yes, and in small and mid-sized companies it usually is, most often with the sachkundige Person under § 14 AMG, with a quality management lead, or with the responsible person for wholesale distribution under § 52a AMG. The limit is practical: § 5 BtMG requires that the person can fulfil the obligations continuously, so a stack of mandates that leaves the function uncovered is a licence problem.

Has medical cannabis changed the market for this role?

It has added employers. Cultivation, import and distribution of medical cannabis sit inside the licensing regime, so the companies built around it need the appointment like any other licence holder. I would treat any claim about the size of that demand with caution, including my own, because the sector has moved quickly and reliable figures are hard to verify.

Sources

§ 3 BtMG, licence requirement (gesetze-im-internet.de, German)
§ 5 BtMG, refusal of the licence (gesetze-im-internet.de, German)
§ 6 BtMG, expertise (gesetze-im-internet.de, German)
§ 7 BtMG, application for the licence (gesetze-im-internet.de, German)
BfArM, Bundesopiumstelle: licences for controlled substances (German)

© 28 July 2026 Andreas Schulz. All rights reserved. This article is career guidance, not legal advice; the statutory text prevails.