SOPREFERENCE OUTLINE

Active Substance Distribution Procedure

Distribution procedure for bulk active substances under the guideline written for them, which is separate from the finished-product one. Begins by confirming the classification and that the finished-product guideline does not govern, then covers member-state registration, traceability to the original manufacturing site through any broker, control of repackaging and relabelling, certificates of analysis tied to the batch supplied, and storage and recall at bulk scale. Maps to EU GDP for Active Substances 2015/C 95/01.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

Checking your Professional access…

REGULATIONS MAPPED
2015/C 95/01
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

The EU publishes separate distribution guidelines for active substances and for finished medicinal products, and they are not interchangeable. This procedure starts by confirming which one governs, because bulk active substance moving from a manufacturer to a factory carries obligations the finished-product guideline never mentions. Classification is your determination, and getting it wrong is silent — nothing about the drum tells you which instrument applies.

What's Inside

✓Classification step confirming which guideline governs, recorded as a determination rather than assumed from the material itself
✓Member-state registration per activity, since importing, holding and supplying are registered separately in many territories
✓Traceability to the original manufacturing site, preserved through every broker and intermediate in the chain
✓Control of repackaging, relabelling and container integrity, with the conditions under which each is permitted
✓Certificates of analysis tied to the batch actually supplied, not passed along from an earlier consignment
✓Storage and transport controls scaled to bulk quantities and to the container types actually used
✓Complaint, return and recall handling reaching the medicinal product manufacturers who already used the material

How to Use It

1Confirm the classification first and record it; the finished-product guideline does not govern bulk active substance, however familiar the customer looks
2Check the intended use, because where the substance is destined for a veterinary product a different instrument applies again
3Register each activity you actually perform in each member state, rather than assuming one registration covers the set
4Name the original manufacturing site on every record; a broker that obscures it breaks traceability the downstream filing depends on
5Issue the certificate of analysis for the batch actually supplied — reusing a previous one is the failure found fastest
6Plan recall to reach the manufacturers who already incorporated the material, not only the customers on the open order book
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Which Guideline Governs
2Registration of the Activity
3Traceability to the Original Manufacturer
4Repackaging, Relabelling and Container Integrity
5Certificates of Analysis
6Storage, Transport and Complaints
REGULATORY CONTEXT

The EU Guidelines on Good Distribution Practice of Active Substances (2015/C 95/01) govern distribution of active substances used as starting materials, and are a separate instrument from the finished-product guidelines at 2013/C 343/01. Neither decides which of them applies to your material — that classification follows intended use and is a determination your organisation records and defends, consignment by consignment. The procedure structure and the sequencing used here are SPEQ practitioner synthesis.

MAPPED STANDARDS
2015/C 95/01
Browse the standards catalog →