Within the EU medicinal-product framework, Qualified Persons perform defined certification responsibilities. EudraLex Volume 4 Annex 16 addresses certification by a Qualified Person and batch release. The exact duties and evidence depend on the product, legal basis and supply chain.
Certification is not a marketing adjective
A QP does not “approve a supplier” in the abstract for every product, jurisdiction and future lot. Commercial diligence must connect the proposed QP and licensed site to the specific manufacturing and import arrangements, product/batch records, testing and applicable authorization or technical basis.
Likewise, locating a GMP certificate in a public database is useful evidence about the named entity, site and recorded scope, but it does not by itself establish product fit, current capacity, batch conformity, import permission or a commitment to certify a proposed batch.
Why the route must be mapped before price comparison
When one quote ends at origin and another includes additional manufacturing, testing, certification or delivery, the headline prices are not comparable. A useful buyer screen separates product price from every downstream component and leaves unknowns visible.
Route checklist
Seven questions before treating the pathway as credible.
What is the exact product stage?
Starting material, intermediate product, bulk medicinal product, finished product or another defined stage. Avoid labels that hide unfinished work.
Which legal entity imports and which site receives?
Record the entity names, addresses, relevant authorization evidence, scope and current-status check.
Which manufacturing activities occur, and where?
Identify processing, treatment, packaging, labelling, testing or other operations and the licensed party responsible for each.
Which QP and licensed site are proposed?
Confirm that a real party has reviewed the contemplated product and route. A general capability deck is not a route commitment.
What evidence and testing will be required?
Define the batch documents, specifications, analytical work, supply-chain evidence and any outstanding data the responsible parties require.
What happens if the batch is rejected or delayed?
Allocate testing, storage, investigation, rework, return/destruction, replacement, cost and timing responsibilities in the commercial terms.
What is certified, when, and what release step follows?
Use the terminology and sequence required by the responsible quality system and legal framework. Do not treat a preliminary review as batch certification or release.
Evidence packet
What a buyer should be able to trace.
Exact legal entities
- Seller and producer
- Importer and receiving site
- Manufacturer/processor
- Testing laboratory
- QP and release site
- Current authorizations and scope
Product-linked record
- Lot/batch identifier
- Origin and traceability
- Manufacturing history
- Specifications and test reports
- Deviations and changes
- Storage and transport conditions
Responsibilities and cost
- Written scope and start conditions
- Samples and testing timeline
- Price inclusions and exclusions
- Loss/yield assumptions
- Rejection and delay allocation
- Quote validity and capacity
Do not let a route exist only in future tense. “Can be QP released” should remain counterparty-stated or proposed until the relevant entities, scope, evidence needs, capacity, timing and written terms are established.
Evidence states
How Provenance labels a route claim.
Registry checked
A current public record was reviewed for the named entity/site and recorded scope. This does not establish product acceptance or capacity.
Document reviewed
A controlled document was reviewed for the stated purpose and date. The label does not convert it into an independent certification by Provenance.
Counterparty stated
The responsible party supplied the information, but corroborating evidence or a binding commitment remains outstanding.
Inferred
A working interpretation derived from available facts. It is never presented as authorization or a party's confirmed position.
Unknown
The point has not been established. It remains a gap and cannot be ranked as a pass.
Expired or stale
Evidence is outside its stated validity or too old for the current commercial decision and must be refreshed.
Primary sources
Start with the official framework.
The responsible licensed entities and qualified professionals must apply these sources to the actual product and transaction.
- European Commission: EudraLex Volume 4 — includes Annex 16, “Certification by a Qualified Person and Batch Release.”
- EUR-Lex: Directive 2001/83/EC, consolidated text — including the EU medicinal-product provisions concerning manufacture/import and Qualified Persons.
- EudraGMDP — manufacturing and import authorizations, GMP certificates and non-compliance statements.
Limit: a public database entry can support a current-scope check. It does not prove that a facility has reviewed, accepted or reserved capacity for a particular cannabis product or batch.