QP certification and the German pharmaceutical import chain, explained for Indian exporters and their German counterparties.

A Qualified Person in Germany is not a rubber stamp. They are a named individual, personally liable under §15 AMG, who refuses to certify a batch if the documentation does not hold. For an Indian exporter selling into Germany, understanding what that person needs — and why India always faces an additional EU retest — is the difference between a smooth supply relationship and a batch that sits in Hamburg for three weeks while the importer’s regulatory affairs team writes emails to Mumbai.

What the Qualified Person actually is.

The Qualified Person is an EU-level construct, defined in Article 51 of Directive 2001/83/EC. Every holder of a manufacturing or importation authorisation in the EU must have at least one QP, and that QP takes personal legal responsibility for certifying that each batch of medicinal product released onto the EU market has been manufactured and tested in accordance with the marketing authorisation and EU GMP.

In Germany the role is implemented through the Arzneimittelgesetz (AMG), which translates the EU construct into the German term Sachkundige Person. Qualifications are defined in §15 AMG: a pharmacy degree plus two years of relevant practical experience, or equivalent scientific qualifications (chemistry, biology, human or veterinary medicine, pharmaceutical technology) with a longer experience window.

Two practical points follow for any Indian exporter thinking about the German market:

• The QP is an individual, not a department. When a batch is released, a named person signs the release — and that person can be called in front of the Landesbehörde if something goes wrong.
• The QP responsible for the batch released in Germany is almost always not the same person as any QP at the Indian manufacturing partner. There are typically two QPs in the chain — the MA holder’s QP (or that of the contract manufacturer inside the EU) and the German importer’s QP — and they have distinct but overlapping duties.

For the Indian side, what matters is that the German QP is the gatekeeper between your batch and the German hospital pharmacy. Everything the regulatory chain does — every document, every test, every audit — ultimately has to let that one person sign the release.

AMG §14, §15 and the German implementation of EU law.

The German framework for manufacturing and importation is built on a handful of AMG sections that anyone working the India–Germany lane should be able to cite from memory.

• §13 AMG — the manufacturing authorisation requirement. Anyone manufacturing a medicinal product in Germany needs one.
• §14 AMG — the conditions under which that manufacturing authorisation is issued, including the mandatory appointment of a Sachkundige Person.
• §15 AMG — the qualifications of the Sachkundige Person and the scope of their responsibility for batch release.
• §72 AMG — the import authorisation required for anyone bringing finished medicinal products into Germany from a non-EU/EEA country. This is the linchpin for Indian-origin imports.
• §72a AMG — the retest and release requirements for imports from third countries without a mutual recognition agreement. India falls under this section.

The authorities that issue and enforce these authorisations are the Landesbehörden — the sixteen state-level health authorities. A German importer based in Stuttgart works with the Regierungspräsidium in Baden-Württemberg; one in Munich works with the Bavarian authority; one in Düsseldorf with the North Rhine-Westphalia authority. BfArM sits above this state-level layer as the federal authority for the marketing authorisation itself (for small-molecule human medicines), while PEI covers biologicals, vaccines and advanced therapies.

The division matters: for a typical Indian generic flowing into a German importer, the MA sits with BfArM, the import authorisation sits with the Landesbehörde, and the QP at the importer’s site answers to both when things go wrong.

The §72 AMG import authorisation — who needs it, how it’s issued.

Any company in Germany that imports a finished medicinal product from a third country — India, China, anywhere outside the EU/EEA — must hold a §72 AMG import authorisation. Without it, the import is not merely irregular, it is prohibited. The authorisation is issued by the Landesbehörde of the state where the importer is physically based.

What the Landesbehörde looks at during the §72 application:

1. The applicant’s suitability and the qualifications of the proposed Sachkundige Person.
2. The physical premises — warehousing, sampling facilities, retained-sample storage, QC laboratory access (owned or contracted).
3. The quality management system, including SOPs for receipt, sampling, retest, release and onward distribution.
4. The intended range of products, the dosage forms and the source countries.
5. Arrangements for the EU retest — whether performed in-house or at a contracted EU-qualified laboratory.

The authorisation is inspected and renewed periodically, typically every two to three years. It is site-specific and scope-specific: adding a new dosage form, a new source country or a new manufacturing partner usually triggers a variation filing.

For Indian exporters, the practical takeaway is simple: verify your German counterparty holds a current §72 AMG authorisation covering the dosage form you intend to supply, and ask for a copy before you ship the first container. A §72 holder has been inspected; a company claiming it will arrange release via a third-party QP without holding one itself is a red flag for the shipment.

The EU retest — why India-origin always triggers it.

This is the most misunderstood part of the chain on the Indian side. The German QP cannot rely exclusively on the Indian manufacturer’s QC test results for batch release. For products imported from a third country, the QP must ensure each batch has been retested inside the EU/EEA against the MA specifications — unless the source country is covered by an EU Mutual Recognition Agreement for GMP.

The EU currently operates GMP MRAs with the United States, Japan, Switzerland, Canada, Israel, Australia and New Zealand. India is not on the list, and has not been added as of the current year. That means every batch of Indian-origin finished product destined for the German market goes through an EU retest, regardless of how thorough the Indian manufacturer’s release testing was.

The retest is not a full re-characterisation. It is a defined subset of analytical work — identity, assay, impurity profile, microbiological parameters where applicable, dissolution for solid dosage forms — carried out either at the importer’s in-house QC laboratory or at a contracted EU-qualified testing lab. Our experience with typical German importers puts this at five to fifteen working days between arrival at Frankfurt and QP release, depending on the analytical complexity and the importer’s laboratory throughput.

Two consequences follow:

• The Indian CoA is necessary but not sufficient. Treat it as the input to the retest, not the replacement for it. Provide the raw QC data on request so the German QP can cross-reference trends.
• The cold chain has to survive the retest dwell. For 2–8 °C products, the importer’s warehouse must hold qualified cold storage for the retest window. Factor this into lead-time conversations with the buyer at the quote stage, not after the PO.

BfArM, the MA dossier and the Indian manufacturing site.

For most Indian generics entering Germany through the standard commercial channel, the marketing authorisation sits with BfArM — the Bundesinstitut für Arzneimittel und Medizinprodukte — as either the Reference Member State in a Decentralised Procedure or the concerned authority in a Mutual Recognition Procedure. Centralised EMA procedures apply to a narrower set of molecules (biotechnology-derived products, orphan drugs, some oncology).

For a generic filed via the abridged route under Article 10 of Directive 2001/83/EC, the dossier BfArM reviews includes:

• The eCTD dossier, Modules 1–5.
• Bioequivalence study results against the European reference medicinal product.
• Module 3 CMC detail on the Indian manufacturing site.
• Stability data covering ICH climate zones II and IVa.
• Evidence of EU GMP compliance at the Indian manufacturing site — either a current GMP certificate issued by an EU member-state authority (BfArM itself, ANSM, AIFA, AEMPS, IGJ, HPRA), or an equivalent written confirmation following an EU-conducted inspection.

The EU GMP certificate for a non-EU site is the operative constraint. It is typically valid for three years from inspection, listed publicly on EudraGMDP, and scope-specific by dosage form. If it expires during the life of the MA, the variation to reinstate coverage is not optional — supply pauses until the site is re-inspected or a sister site with a current certificate is qualified in.

For the German QP on the import side, the BfArM MA is the reference document against which the batch is checked. Product composition, packaging, shelf life, indications, label text — all flow from the MA, and any batch that deviates is not releasable.

What the Indian exporter sends the German QP, every single time.

The German QP’s decision runs on documentation. The Indian manufacturer’s pack has to be complete and consistent, and it has to arrive with the batch, not three emails later. In our experience, a shipment-ready pack from the Indian side includes:

1. Manufacturer Batch Record, complete, with process parameters, in-process control results and any deviations formally recorded and resolved.
2. Certificate of Analysis, batch-specific, signed by the QC head, with the manufacturer’s release decision clearly stated.
3. Certificate of Compliance, confirming the batch matches the MA dossier on file at BfArM.
4. Manufacturer’s QC test raw data, available on request — chromatograms, spectra, microbiological plates as applicable.
5. Cold-chain logger data for any product travelling under a temperature claim, with excursion protocol written before dispatch.
6. Stability update where the batch extends the declared shelf life beyond the last supported stability pull point.
7. Training and calibration records on request during periodic audit.
8. Declaration of conformity with EU GMP from the manufacturing site, referencing the current EudraGMDP certificate.

Language matters. Batch records, SOPs, deviation reports and investigation summaries are best provided in English. German is preferred for final regulatory correspondence but English is universally accepted for technical documents. What does not work is Hindi-annotated raw data the German QP cannot read — that blocks the release while a translation is commissioned.

Periodic audit is the other half of the equation. The German QP’s team will audit the Indian manufacturing site on a defined periodicity, typically every two to three years. A desk audit may be acceptable for low-risk products with a clean history; an on-site audit is generally required for sterile injectables, biologicals and cold-chain products, or when a significant deviation has occurred.

Five errors that stall first-time India–Germany supply.

After working enough India–Germany lanes, the same five mistakes surface in first-time supply relationships. All are avoidable with a pre-shipment documentation review.

1. Assuming the Indian QC eliminates the EU retest. It does not — India is not on the EU MRA list. Plan for the five- to fifteen-day retest dwell; do not promise the buyer a next-day release.
2. Sending a CoA without the batch record. The German QP is not releasing on a CoA alone. The manufacturer batch record, the deviation history and the in-process control data all need to be in the pack.
3. Shipping into an importer without a current §72 AMG authorisation. The container will sit. Verify the German counterparty holds the authorisation, covering the dosage form you are shipping, before the first order.
4. EU GMP inspection outside the three-year validity window. BfArM will not accept the MA’s GMP evidence, and the MA itself may need a variation. Track your manufacturing partner’s EudraGMDP expiry six months ahead and plan the re-inspection pathway early.
5. Non-English or non-German technical documents. The QP needs to read every page. Hindi-annotated chromatograms, vendor certificates only in the supplier’s native language, SOPs in a non-European script — each adds a translation cycle before release.

None of these are exotic problems. They are the standard failure modes when a new Indian supplier meets a new German importer, and they are the reason the first three shipments of a new supply relationship routinely take longer than the contract predicts. The second year is when the lane settles.

FAQ

What is the difference between a QP in Germany and one at an Indian manufacturing site?

The German QP — Sachkundige Person under §15 AMG — is personally and legally responsible for certifying that each batch released onto the German market complies with the marketing authorisation and EU GMP. The QP at the Indian manufacturing site (where one exists) signs off on manufacture to the site’s own GMP standards. For Indian-origin product entering Germany, there are typically two QPs in the chain and the German QP’s signature is the one that puts stock into the Apotheken or Krankenhausapotheken supply chain. The duties are distinct but the documentation flows between them.

Does an Indian exporter need a §72 AMG authorisation to supply Germany?

No. The §72 AMG import authorisation is held by the German-side importer, not the Indian exporter. M Care, as an Indian pharmaceutical exporter, does not hold and cannot hold a §72 AMG — the authorisation is issued by the German Landesbehörde to a company operating on German soil. What the Indian exporter should do is verify the German counterparty holds a current §72 authorisation covering the specific dosage form being supplied, and ask for a copy before the first shipment. Supplying into a counterparty without one puts the batch at legal risk.

Why is an EU retest required for Indian batches when the Indian QC has already tested them?

Because India is not covered by an EU Mutual Recognition Agreement for GMP. The EU maintains MRAs with the United States, Japan, Switzerland, Canada, Israel, Australia and New Zealand; batches from those countries can be released by the EU QP without a physical retest inside the EU. For everywhere else, including India, EU GMP import rules require that the batch be tested inside the EU/EEA against the MA specifications before QP release. This is typically a five- to fifteen-day dwell at the importer’s warehouse.

What does M Care provide to a German importer that shortens the QP release cycle?

The complete source-side pack, in English, before the batch departs Mumbai: manufacturer batch record, batch-specific CoA, certificate of compliance to the BfArM MA dossier, QC raw data on request, cold-chain logger validation, stability update where relevant, and the EudraGMDP reference for the manufacturing site’s current EU GMP certificate. We have supported our German importers through EU GMP inspections of Indian partner sites by ANSM, AIFA and BfArM, and the pack is designed so the German QP can move directly to retest scheduling without an email round-trip back to the manufacturer.