NACE 21.1 – Manufacture of Basic Pharmaceutical Products | Public Tenders

Definition: NACE 21.1 covers the manufacture of basic pharmaceutical products (Active Pharmaceutical Ingredients, APIs) — i.e. active substances used as starting materials for the production of medicinal products. This group is of strategic importance for public healthcare, as hospitals, pharmacies of public bodies and state health authorities depend on a secure supply of pharmaceutical active substances.

Legal basis: NACE Rev. 2 (Regulation (EC) No 1893/2006) · Last updated: January 2026

What does NACE 21.1 cover?

NACE 21.1 (Manufacture of basic pharmaceutical products) classifies businesses that synthesise, ferment or extract starting materials for medicinal products from natural sources — a key industry for public hospital procurement and state health strategies.

Group 21.1 within Section C (Manufacturing) and Division 21 (Pharmaceutical industry) covers:

The most important product categories include chemically synthesised active substances (e.g. paracetamol API, ibuprofen API), biotechnologically produced substances (e.g. insulin, monoclonal antibodies as raw materials) and extracts from plant or animal sources. These basic substances are not supplied directly to end users but are sold on to pharmaceutical manufacturers in NACE group 21.2.

Public tenders: scope of NACE 21.1

Direct public procurement of pharmaceutical basic products takes place primarily through state pharmaceutical operations, Bundeswehr pharmaceutical depots and research institutions — but the significantly larger procurement volume arises from hospitals and statutory health insurance facilities procuring medicinal products based on these active substances.

Typical contract types

• Active-substance procurement for hospital pharmacies: Direct purchase of APIs for in-house compounding by hospital pharmacies (section 21 AMG exemptions)
• Strategic stockpiling: State procurement of active-substance reserves for crisis scenarios (pandemic preparedness, civil protection)
• Bundeswehr medical services: Procurement of active substances for military pharmaceutical depots and field medical material
• Research institutions: Procurement of reference substances and pharmaceutical basic products for publicly funded research projects
• Blood products and plasma proteins: Procurement of blood derivatives for transfusion medicine in public clinics

Thresholds and procedure types

Supply contracts for pharmaceutical basic products are subject to the threshold of EUR 221,000 where EU-wide relevance applies (supplies for federal authorities: EUR 143,000). Owing to the regulated market and GMP requirements (Good Manufacturing Practice), the negotiated procedure with prior call for competition or competitive dialogue is frequently used where complex technical specifications need to be clarified.

Relevant CPV codes for NACE 21.1

CPV codes enable targeted searching for tenders on pharmaceutical basic products and related laboratory chemicals on TED and national procurement platforms.

Current tenders are published on TED (Tenders Electronic Daily) and on the German Procurement Portal (DTVP) and the procurement platform of the Procurement Office of the BMI.

For whom is NACE 21.1 relevant under procurement law?

Public contracting authorities

The main contracting authorities for pharmaceutical basic products in the public sector are publicly owned hospitals and university clinics with their own hospital pharmacies, BAAINBw for military medical material, the Paul Ehrlich Institute (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM) for reference substances, and the Federal Pharmacy and state health-preparedness institutions.

Companies and bidders

Pharmaceutical active-substance manufacturers seeking public contracts must meet extensive regulatory requirements:

• GMP certification: An EU GMP certificate per Annex 18/ICH Q7 is mandatory; inspection by the competent authority (e.g. state health authority)
• ASMF/DMF: Active Substance Master File as evidence of active-substance quality vis-à-vis medicines authorities
• REACH and ADR compliance: Adherence to chemical-law and dangerous-goods transport rules
• Supply security and dual sourcing: Public contracting authorities increasingly value supply security — evidence of alternative production sites and safety stocks is required
• Import certificates: Active substances from third countries require an import certificate under section 72a AMG

NACE 21.1 in context: Section C and Division 21

NACE 21.1 is part of Division 21 (Pharmaceutical industry) — one of the most strongly regulated and, at the same time, most procurement-relevant areas in manufacturing.

• NACE C – Manufacturing: Parent section
• NACE 21 – Manufacture of pharmaceutical products: Parent division
• NACE 21.2 – Manufacture of pharmaceutical preparations: Finished medicines, vaccines, dressings
• NACE 20 – Manufacture of chemicals and chemical products: Upstream chemical industry

Frequently asked questions about NACE 21.1 and public tenders

Which businesses fall under NACE 21.1? Businesses that produce pharmaceutical active substances (APIs) synthetically, by fermentation or by extraction from natural sources. These include classic API manufacturers, biotechnology businesses with API production, and producers of blood derivatives.

Why is supply security for pharmaceutical basic products a procurement topic? The COVID-19 pandemic showed that strong dependence on non-European producers (particularly China and India) can lead to supply bottlenecks. The EU and the federal government therefore support reshoring of API production to Europe — with implications for public procurement strategies (multi-sourcing, resilience clauses).

How are pharmaceutical basic products quality-assured in procurement? Technical specifications in the tender documents require GMP compliance, certificates from competent authorities, certificates of analysis (CoA) and stability data. Manufacturer visits (audits) can be envisaged as a suitability criterion.

Are tenders for medicines by statutory health insurance funds considered public tenders? Discount agreements by statutory health insurance funds under section 130a SGB V are procurement-law relevant and subject to GWB procurement law once the thresholds are exceeded — a central procurement format for medicines and related basic substances.

Last updated: January 2026 All information provided without warranty. For legally binding advice, please consult a law firm specialising in public procurement law.