Service
Export documentation for medicines: COA, COPP, MSDS and dossiers
Registering a medicine and clearing it through customs both run on paper. Progene Pharma prepares the certificates, the registration dossier and the shipping documents for every product we manufacture, in the format your regulator and port expect, so your shipment is not held up by a missing page.
- Certificates
- COA, COPP, GMP
- Dossiers
- CTD and ACTD
- Shipping
- Invoice, packing list, origin
- Supply
- Export only, worldwide
What is export documentation?
Export documentation is the set of papers that lets a medicine be registered in the importing country and cross the border. It comes in two kinds. Registration documents are prepared once for each product and country: the dossier, the certificate of pharmaceutical product, the GMP certificate and stability data. Shipment documents travel with every order: the certificate of analysis, the invoice, the packing list and the certificate of origin.
Progene Pharma prepares both kinds for the products we manufacture. Your company, as the importer, files the registration with your regulator and clears each shipment with customs, and we answer their questions with you.
Who needs export documentation
Anyone who registers or imports a medicine, and wants the paperwork right the first time.
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Importers and distributors
Register products in your country and clear each shipment through customs without queries.
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Brand owners
Register a private label product in your company's name, with the manufacturer's certificates behind it.
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Tender suppliers
Submit the certificates and product documents a tender asks for, in the format it specifies.
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Hospital and healthcare groups
Show your own regulator or pharmacy board that the medicines you buy are made to a recognised standard.
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Health programmes and NGOs
Meet donor and programme requirements for quality assurance and traceability.
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Regulatory consultants
Get a complete, consistent set of manufacturer documents to build your client's submission.
We prepare the documents. You file them.
A clear division of work, so the dossier is accurate and the filing stays under your control.
You provide
- The product, strength and pack you want to register
- Your country and the authority you file with
- Your import licence and, where needed, the import permit
- The registration filing, in your company's name
- Customs clearance in your country
We handle
- The CTD or ACTD dossier, with stability data
- The COPP and a copy of the GMP certificate
- A COA for every batch
- MSDS, Free Sale Certificate and samples
- Invoice, packing list and certificate of origin
- Answers to your regulator's questions
The documents, one by one
What each document is, and why your regulator or customs asks for it.
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Certificate of Analysis (COA)
Test results for one batch against its specification. It travels with every shipment and is often checked at the port.
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Certificate of Pharmaceutical Product (COPP)
A certificate in the WHO format, issued by the regulator of the exporting country, confirming the product is authorised and made to GMP.
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GMP certificate
A copy of the manufacturing facility's WHO-GMP certificate, which many regulators ask for before registering a product.
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CTD and ACTD dossier
The registration file in the Common Technical Document format, or the ASEAN version, with the data on quality, manufacture and stability.
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Stability data
Studies showing how the product holds up in storage, at the climate zone of your market, which set its shelf life.
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MSDS
A safety data sheet for handling, storage and transport, needed for freight and customs.
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Free Sale Certificate
Proof that the product can be sold freely, which some regulators ask for in addition to the COPP.
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Invoice and packing list
The commercial invoice and a packing list of every carton, for customs value and clearance.
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Certificate of origin
A certificate stating where the goods were made, used by customs to decide duties and, in some countries, to allow the shipment in.
Documents for every category
The core set is the same, and each category adds what its regulator expects. Download the product list (PDF)
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Human formulations
COPP, CTD or ACTD dossier and stability data for registration with the medicines regulator.
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Veterinary medicines
A dossier in the format your veterinary authority asks for, plus label artwork with the withdrawal period.
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Nutraceuticals
Product specification, GMP certificate and label artwork for registration or notification as a supplement.
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Herbal and Ayurvedic
Specification, quality test reports and label artwork for registration as a herbal product.
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Cosmetic and personal care
The formula with INCI names, stability and preservative tests for your safety assessment or notification.
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DC granules and pellets
Specification, method of analysis and stability data for the finished-product dossier.
How documentation works with an order
Registration documents come first, because most countries will not accept a shipment of an unregistered product.
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01
Tell us your country
The product, strength and the authority you register with, so we know which format and documents apply.
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02
Confirm the list
We confirm the documents your regulator and customs expect, and which we can supply, with your quotation.
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03
Registration documents
We send the dossier, COPP, GMP certificate and samples before the first shipment, for you to file.
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04
Batch documents
Each batch is released with its COA and shipped with the invoice, packing list and certificate of origin.
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05
Customs and renewals
We answer queries from your regulator and customs, and refresh the documents when they come up for renewal.
Why importers choose Progene Pharma
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Since 2006
Two decades of exporting medicines to distributors in Africa, Asia, Latin America, the Middle East and Europe.
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Made and documented together
The team that manufactures the product prepares its documents, so the paperwork matches the batch.
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Certified manufacturing
Progene Pharma manufactures in a WHO-GMP certified facility, also certified to EU-GMP and ISO, matched to the standard your market accepts.
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Answers after the filing
We reply to your regulator's questions and renewal requests, not only at the start.
Questions about export documentation
Something else? Email [email protected].
Which documents are needed to export medicines?
For registration: a CTD or ACTD dossier, a COPP, a GMP certificate and stability data. For each shipment: a Certificate of Analysis, a commercial invoice, a packing list and a certificate of origin. Some countries ask for more, such as a Free Sale Certificate, so tell us your country and we will confirm.
What is the difference between a COA and a COPP?
A COA (Certificate of Analysis) shows the test results of one batch against its specification, and goes with every shipment. A COPP (Certificate of Pharmaceutical Product) is a WHO-format certificate, issued by the regulator of the exporting country, confirming the product is authorised and made to GMP. It is used to register the product.
What is a CTD dossier?
The Common Technical Document is the standard format for a medicine's registration file, covering its quality, manufacture, stability and, where required, safety and efficacy. Many regulators accept it, and ASEAN countries use a similar version, the ACTD.
Do documents come with every shipment?
Yes. Every batch ships with its Certificate of Analysis, the commercial invoice, the packing list and the certificate of origin, plus any other document your import permit calls for. Registration documents are sent once per product, before the first shipment.
Can you prepare documents in the format my regulator asks for?
Yes. Tell us the authority and we prepare the dossier and certificates in the format it uses. Where it needs a document we do not hold, we tell you in the quotation.
Can you attest or legalise documents for my country?
Where your country asks for documents to be attested by a chamber of commerce or an embassy, tell us when you order and we will confirm what we can arrange.
How long does it take to prepare the documents?
It depends on the product and the country. Documents for a product we already make are usually ready sooner than a dossier for a new formula. We confirm the schedule with your quotation.
Do you offer export documentation for the Indian market?
No. Progene Pharma's documentation is for export only. We supply importers, distributors and brand owners outside India.
Explore more
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494