# Buying APIs from India: the EU document checklist

Source: https://gfclinics.pl/insights/indian-api-import-documentation-checklist/
Updated: 2026-10-17

An API from India needs evidence of EU GMP, a CEP or ASMF, and a written confirmation from India's regulator. Each batch needs a specification and certificate of analysis. In Poland, the importer registers with GIF and follows EU GDP for active substances.

An active pharmaceutical ingredient (API), or active substance, is the substance that becomes the active ingredient of a medicinal product. An API imported into the EU must be made under GMP equivalent to EU standards. Unless the exporting country is on a Commission list, it must also travel with a written confirmation from that country's regulator. Buyers check three layers of documents: the manufacturer, the product and each batch, and the importing side in the EU.

## What must the manufacturer provide?

Three documents establish whether a site can supply the EU at all.

- **Evidence of EU GMP.** Look for an EU GMP certificate or a recent inspection record in EudraGMDP, where EU authorities record GMP certificates. A CEP alone is not a GMP certificate.
- **CEP or ASMF.** These documents carry the quality data for the marketing authorisation dossier. Check a CEP's status in the EDQM Certification database. For an ASMF, confirm the reference number and that the holder will issue a letter of access.
- **Written Confirmation (WC).** Under Article 46b(2)(b) of Directive 2001/83/EC, imported APIs must be accompanied by a written confirmation from the exporting country's authority. It states that the site follows GMP at least equivalent to EU GMP and is regularly inspected. India is not on the Commission's list of exempt countries. In India, the Central Drugs Standard Control Organisation (CDSCO) issues WCs and publishes them on its website.

### What a written confirmation does not do

A WC does not replace the buyer's own checks. Article 46b states that it is without prejudice to the manufacturing authorisation holder's duty to audit API suppliers. A Member State may waive the WC only exceptionally, to keep medicines available, and only for a site that an EU Member State has inspected and found GMP-compliant. Buyers should not plan supply around that waiver.

## Which documents cover the product and each batch?

| Document | What to check | Reference |
|---|---|---|
| Specification | All Ph. Eur. monograph tests plus extra tests on the CEP; product-specific attributes added by the buyer | EMA CEP Q&A, S.4.1 |
| Certificate of analysis (CoA) | One per delivered batch; batch number, results against the agreed specification, date and authorised signature | EU GMP Part II, 11.4; EU GDP for active substances, 6.2 |
| Stability data | Data supporting the retest period, or a CEP that states one | ICH Q1A(R2); EMA CEP Q&A, S.7 |
| Nitrosamine risk assessment | Route-specific assessment; data on impurities with vulnerable amines | EMA nitrosamine guidance |
| Residual solvents | Solvents used and their control; note if ICH Q3C option 2 was applied | ICH Q3C (R9) |
| Elemental impurities | Information on potential sources, such as catalysts, equipment and water, for the medicine's risk assessment | ICH Q3D (R2) |
| TSE/BSE statement | Declaration of no animal-derived materials, or a TSE CEP | EMA/410/01 rev.3 |

Two practical points apply to every row. First, documents should name the same site and the same synthetic route as the CEP or ASMF. Second, the finished-product manufacturer must test enough batches itself to qualify the source.

## What applies on the importer side in Poland?

### Registration with GIF

Any company that manufactures, imports or distributes active substances in Poland needs an entry in the National Register of Manufacturers, Importers and Distributors of Active Substances. The register is kept by the Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny, GIF) under Articles 51b–51d of the Pharmaceutical Law. The application must be filed at least 60 days before the activity starts. GIF may decide to inspect first. The register is public, and registrants report changes once a year. This implements Article 52a of Directive 2001/83/EC, which also requires Member States to enter registrations in the EU database, EudraGMDP. A buyer can therefore confirm a distributor's or importer's registration before placing an order.

### EU GDP for active substances

The EU guidelines on Good Distribution Practice of active substances (2015/C 95/01) apply to procuring, importing, holding, supplying and exporting APIs. They require a quality system, traceable records that include the original manufacturer, and checks on receipt. Repackaging or relabelling counts as manufacturing and falls under EU GMP Part II.

### QP certification at the finished-product manufacturer

The manufacturing authorisation holder may only use APIs made under GMP and distributed under GDP. It must verify this by audits (Article 46(f)). Its qualified person (QP) signs the QP declaration on the API sites for the dossier. The QP then certifies each finished-product batch under EudraLex Volume 4, Annex 16.

## Is the legal basis changing?

Yes, but not yet. On 28 September 2026 the Council adopted its first-reading position on a new directive that will repeal Directive 2001/83/EC. The text still needs the European Parliament's second-reading approval, and Member States must then transpose it. Until then, Articles 46b and 52a remain the reference.

## Questions to ask a supplier before requesting a sample

1. Which site makes the API, and which steps happen at other sites, including micronisation?
2. Do you hold a valid CEP or an ASMF for this site and route? What are the CEP number and revision?
3. When was the site last inspected by an EU/EEA authority or the EDQM, and with what outcome?
4. Do you hold a current CDSCO written confirmation that covers this API and this site?
5. Will you sign a quality agreement that obliges you to notify changes before you implement them?
6. Can you share your nitrosamine risk assessment and data on impurities with vulnerable amines?
7. Which solvents and catalysts does the route use, and do you have an ICH Q3D risk assessment?
8. What retest period do you support, in which packaging, and with what stability data?
9. Does the process use any material of animal origin?
10. Will the sample come from a commercial batch, with a full certificate of analysis?

## How Green Future Clinics uses this

We use this checklist when we qualify an Indian API manufacturer. We ask for the documents in the table before we offer a price, and we check the CEP and EudraGMDP entries ourselves. Where an import requires a GIF-registered active-substance importer, we state in the offer which party in the chain holds that registration. Gaps are reported to the customer in writing. The audit, the QP declaration and the release decision stay with the customer.

## Sources

- Directive 2001/83/EC, consolidated text of 1 January 2025 (Articles 46, 46b, 52a): https://publications.europa.eu/resource/celex/02001L0083-20250101
- European Commission – Importation of active substances: listing of third countries: https://health.ec.europa.eu/medicinal-products/falsified-medicines/importation-active-substances-listing-third-countries_en
- CDSCO (India) – International Cell: written confirmations for export of APIs to the EU: https://cdsco.gov.in/opencms/opencms/en/International-cell1/
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances (2015/C 95/01): https://publications.europa.eu/resource/celex/52015XC0321%2801%29
- Prawo farmaceutyczne – consolidated text, Dz.U. 2026 poz. 612 (Articles 51b–51d): https://dziennikustaw.gov.pl/DU/2026/612
- EudraGMDP – public database of manufacturing authorisations, GMP certificates and API registrations: https://eudragmdp.ema.europa.eu/inspections/displayWelcome.do
- EDQM – Certification database (Certificates catalogue): https://extranet.edqm.eu/publications/recherches_CEP.shtml
- EMA – QWP Q&A: how to use a CEP in a marketing authorisation application or variation (Rev.1, 28 January 2026): https://www.ema.europa.eu/system/files/documents/scientific-guideline/questions-answers-how-use-cep-context-marketing-authorisation-application-en.pdf
- EMA – Nitrosamine impurities: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities
- EMA – ICH Q3C (R9) Residual solvents: https://www.ema.europa.eu/en/ich-q3c-r9-residual-solvents-scientific-guideline
- EMA – ICH Q3D Elemental impurities (R2): https://www.ema.europa.eu/en/ich-q3d-elemental-impurities-scientific-guideline
- EMA – Minimising the risk of transmitting animal spongiform encephalopathy agents (EMA/410/01 rev.3): https://www.ema.europa.eu/en/minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-veterinary-medicinal-products-scientific-guideline
- European Commission – EudraLex Volume 4: Good Manufacturing Practice guidelines: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
- Position (EU) No 11/2026 of the Council at first reading on the Union code relating to medicinal products for human use (OJ C/2026/5269): https://publications.europa.eu/resource/celex/52026AG0011%2801%29